The proposal and application of the "Suture Formula" make single port laparoscopic myomectomy simpler and more efficient: a retrospective cohort study

doi:10.21203/rs.3.rs-5345088/v1

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The proposal and application of the "Suture Formula" make single port laparoscopic myomectomy simpler and more efficient: a retrospective cohort study

https://doi.org/10.21203/rs.3.rs-5345088/v1

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Background: Single-port laparoscopic surgery offers unique minimally invasive and cosmetic results and facilitates the patient's postoperative recovery.In transumbilical single-port laparoscopic myomectomy, suturing of the uterine wound is a critical intraoperative step.Due to the difficulty of operating with a single hole, it takes longer to suture the uterine wound, which somewhat increases the potential risk and limits the development of this procedure.This study describes the technique of the "suture formula" and compares it with the traditional randomized suture pattern.

Materials and Methods:The author's team summarized the uterine incision selection and suture pattern in single-port laparoscopic myomectomy, conceptualizing the steps of uterine incision selection and suture closure to reduce unnecessary intraoperative backstitching and thread winding operations.In this study, we retrospectively analyzed 91 patients who underwent transumbilical single-port laparoscopic myomectomy and compared the intraoperative and postoperative indices between the two groups.

Results:Surgical time, intraoperative bleeding, and hemoglobin drop were lower in the "suture mode" group than in the traditional randomized suture group (p<0.05).There was no statistically significant difference between the "suture formula" group and the traditional randomized suture group in terms of the number of days of postoperative hospitalization, the time to the first postoperative anal evacuation, the VAS score at 12h postoperatively, the VAS score at 24h postoperatively, and the postoperative complications (P > 0.05).Suture pattern (Beta: -19, P=0.043), number of leiomyosarcomas (Beta: 43, P=0.002), maximum diameter of the tumor (Beta: 6.2, P=0.032), and BMI (Beta: 4.0, P=0.018) were the factors influencing the duration of surgery.Suture pattern (Beta: -46, p=0.011), and maximum tumor diameter (Beta: 13, p=0.027) were the factors influencing intraoperative bleeding.

Conclusion:The "Suture Formula" technique conceptualizes the selection of the uterine incision and the suture steps, which reduces the difficulty of the operation and ensures the hemostatic effect while reducing the unnecessary inverted needle and thread wrapping during the operation, thus shortening the operation time and improving the efficiency of the operation.The use of the "suture formula" does not increase the risk of surgery or the incidence of surgical complications compared with conventional single-port laparoscopic myomectomy.This suture pattern provides a new breakthrough in single-port laparoscopic myomectomy.

Single-port laparoscopic surgery

Hysteromyoma

Suture formula

Suture Technique

Single-port laparoscopic suturing of uterine wounds is difficult and time-consuming, leading to potential risks.
We have summarized the uterine incision selection and suture pattern in single-port laparoscopic myomectomy, which we call the "suture formula".
After selecting the appropriate incision, the "Suture Formula" conceptualizes the suture steps and improves surgical efficiency.
The "suture formula" is more advantageous in terms of reducing the difficulty of the operation, shortening the operation time and reducing intraoperative bleeding.
The "suture formula" provides a new breakthrough in single-port laparoscopic myomectomy.

Uterine smooth muscle tumors (also known as uterine fibroids) are clinically the most prevalent benign tumors of the female reproductive system. Its occurrence is mainly associated with the proliferation of uterine smooth muscle cells[1].In recent years, the incidence of uterine fibroids tends to be younger. As the size of leiomyoma increases, patients may experience increased menstrual flow, anemia, and pressure symptoms, which threaten women's health[2].Surgery is the primary treatment for this disease. Myomectomy may be performed in patients with a need or indication for uterine preservation.Traditional open abdominal surgery is more traumatic and has a great impact on the patient's postoperative recovery[3].Driven by the concept of minimally invasive, laparoscopic surgery has become a routine procedure for myomectomy.In recent years, transumbilical single-port laparoscopic surgery (TU-LESS) has been favored for its unique minimally invasive and cosmetic results[4].

Combined with the vascular distribution and blood supply characteristics of uterine fibroids, intraoperative bleeding is almost inevitable[5].Single-port laparoscopic operation has obvious "chopstick effect", which makes it difficult to suture the tumor cavity, and is prone to prolonged operation time and intraoperative bleeding, which increases the chance of supplemental suturing for hemostasis[6].This feature severely limits the development of single-port laparoscopic techniques in the field of myomectomy.A study has used the "hook-assisted method"[7] in transumbilical single-port laparoscopic myomectomy, trying to reduce the difficulty of the operation by using the suspension of the uterus by the hook to immobilize the uterine trauma.A study has also used the "suspended line method" [8]in transumbilical single-hole laparoscopic myomectomy, attempting to use the hanging wire to fix the uterine trauma, and adjusting the position of the fixed uterine trauma by pulling the hanging wire to reduce the difficulty of the operation.Although all of these methods require the addition of necessary consumables as well as new abdominal wall trauma, relevant experimental data confirm that these adjunctive methods are safe and effective.

Our team performed the first single-port laparoscopic myomectomy in 2012, and the volume of single-port laparoscopic myomectomy surgeries peaked in 2017–2020, and we have survived the initial learning phase in the learning curve of single-port laparoscopic myomectomy in nearly 10 years of exploration and practice.In early 2022, our team summarized the suture pattern based on the minimally invasive concept without any additional trauma to the abdominal wall, and we called the summarized suture pattern the "suture formula"[9].Prior to the introduction of the "suture formula", the selection of uterine incisions and suture methods tended to be randomized and lacked certain rules and regulations, and the uterine incisions were often sutured with frequent backstitching and thread wrapping due to angulation problems, or additional suture operations were performed due to bleeding from the incision for a variety of reasons.As a result, the operator often feels that the procedure is difficult under the traditional randomized suture pattern.The "Suture Formula" conceptualizes the steps of suturing, which ensures hemostasis and reduces unnecessary intraoperative backstitching and thread wrapping, thus shortening surgical time, improving surgical efficiency, and reducing potential risks.In order to evaluate the efficacy and safety of the "Suture Formula", we compared the "Suture Formula" suture pattern with the traditional randomized suture pattern in a retrospective comparative cohort study. This is reported as follows.

Study population

We conducted a retrospective comparative cohort study to analyze the data of patients who underwent single-port laparoscopic myomectomy from March 2020 to September 2023 at the Second People's Hospital of Changzhou City affiliated with Nanjing Medical University.Inclusion criteria：①All patients underwent successful transumbilical single-port laparoscopic myomectomy; ②all patients' pathology was uterine smooth muscle tumor;③age 18-60 years old; ④BMI <35 kg/m2; ⑤preoperative HB ≥80 g/L.Exclusion Criteria：①postoperative pathology of malignant tumors; ②intraoperative finding of severe pelvic or abdominal adhesions; ③maximum diameter of the tumor >15 cm;④ combination of severe cardiopulmonary dysfunction.After applying these inclusion and exclusion criteria, the included patients were divided into "suture formula" group and "traditional randomized suture" group according to the mode of intraoperative suturing of the uterine wound（Fig.1）.All surgeries were performed by the same group of doctors.

Surgical procedure of myomectomy under LESS with"suture formula"

All patients completed preoperative auxiliary examinations such as blood routine, coagulation function, liver and kidney function, electrocardiogram, ultrasound, etc., to exclude contraindications to surgery.The umbilical orifice was fully disinfected preoperatively, and vulvar skin preparation and vaginal scrubbing were performed.Oral laxatives, enemas, and fasting for more than 6 hours were given 1 day before surgery.Prophylactic antibiotics were given 30 minutes before surgery.

The patient took the amputation on the operating table, and after successful tracheal intubation for general anesthesia, routine vulvar, vaginal, and abdominal surgical field disinfection, laying of sterile towel sheet, insertion of urinary catheter, and insertion of uterine lifter were performed.Sterilize the umbilicus again.The umbilical hole was taken as the puncture point, the skin on both sides of the umbilical hole was lifted up with scarf pliers, the umbilical hole was incised longitudinally for about 1.5 cm, and downward incision was made to enter into the abdomen layer by layer, a single-hole Port was placed, and a pneumoperitoneum was established, and the abdominal pressure was set at 12 mmHg.A 30° conventional laparoscopic lens was introduced to fully explore the pelvic-abdominal cavity and assess the feasibility of the procedure.If pelvic adhesions or intestinal adhesions interfere with the surgery, the adhesion bands are separated with a monopolar electric hook to restore the tissue to its normal anatomy and fully expose the surgical field.Diluted posterior pituitary hormone was injected at the junction of the fibroid envelope and the uterine body.A unipolar electric hook was used to longitudinally incise the plasma membrane of the uterus at the bulge to the tumor, and a combination of blunt and sharp resection of the tumor was performed to remove the fibroid from the umbilicus.Fibroid tumors can be removed in pieces if they are large in diameter.Fibroid specimens were sent for rapid pathologic examination.The tumor cavity was closed with absorbable barbed sutures.Suture is performed using the "Suture Formula".

Under single-port laparoscopy, our team observed that when a longitudinal uterine incision is used, the angle of the needle holder is parallel to the incision, which makes suturing less difficult and is more conducive to suture manipulation of the incision.Therefore, the use of the "suture formula" is based on a longitudinal uterine incision (Fig. 2A)[9].In order to adopt the "suture formula", the following concepts need to be clarified first.Positive needle: needle on the left side of the needle holder, tip up (Fig. 2B).Counter-needle: the needle is on the right side of the needle holder, with the tip pointing upwards (Fig. 2C).Backwards needle: the needle is on the left side of the needle holder with the tip down (Fig. 2D).Orthogonal suture: the point of needle entry is on the right side of the incision or cutting edge, and the point of needle exit is on the left side of the incision or cutting edge (Fig. 2B).Reverse suture: the point of needle entry is to the left of the incision or cutting edge, and the point of needle exit is to the right of the incision or cutting edge (Fig. 2C).When continuous baseball suture is used, anterior uterine wall incision: left margin positive needle positive suture (Fig. 2B), right margin reverse needle negative suture (Fig. 2C); posterior uterine wall incision: left margin reverse needle positive suture (Fig. 2D), right margin positive needle negative suture (Fig. 2E)[9].A study has shown that the inside-out needle travel characteristic of the baseball suture allows for better hemostasis after tensioning the suture with pressure going in the direction of the smooth muscle of the uterus[10].Therefore, continuous baseball suture (Fig. 2F) is used in all cases where the "suture formula" is used.

After suturing was completed, the wound and pelvic and abdominal cavities were rinsed with saline and checked for no active bleeding.Hemostatic gauze and sodium hyaluronate were placed to prevent adhesions, and abdominal drains were placed as appropriate depending on the intraoperative situation.If a drain is placed, an abdominal drain is secured to the anterior end of the umbilical incision.After the count was correct, the air was deflated, the single-hole Port was removed, and the umbilical fascia and skin incision were closed layer by layer.Use alcohol cotton balls and dry gauze to apply pressure bandages.Postoperatively, cardiac monitoring, low-flow oxygen, antibiotics to prevent infection, nutrition and rehydration, promote contraction and other symptomatic treatment, if necessary, pain relief, prophylactic anticoagulation and other treatments.Wound dressing was changed on the first postoperative day, patients were encouraged to get out of bed appropriately, and the urinary catheter was removed 24 hours after the operation.

Surgical procedure of traditional single-port laparoscopic myomectomy

The preoperative preparation was similar to that of the "suture formula" group.The surgical procedure prior to myoma debulking is the same as in the "suture formula" group.The choice of uterine incision for the site of the fibroid is based on intraoperative maneuverability by the surgeon at the time.The procedure for myomectomy is similar to that of the "suture formula" group.Suturing of the uterine incision is also performed according to the intraoperative maneuverability of the surgeon at the time, and the main suture methods used include simple continuous sutures and continuous baseball sutures.The surgical procedure and postoperative treatment after suture completion is the same as that of the "suture formula" group.

Data collection

The procedure was approved by the hospital ethics committee(2017-Y-15-01).Written informed consent was obtained from the patient.All data were obtained from patients' medical records.Patients' basic information, clinical data, intraoperative conditions and early postoperative outcomes were analyzed.

Outcome

The primary study endpoint was operative time in the "suture formula" and "traditional randomized suture" groups.Secondary study endpoints were intraoperative bleeding, hemoglobin drop values, postoperative hospital days, time to first postoperative anal defecation, 12h postoperative VAS scores, 24h postoperative VAS scores, and surgical complications in both groups.

The Visual analogue scale (VAS) is used to score pain and is more widely used in Chinese clinics.Patients rate their pain level on a scale of "0" for no pain and "10" for unbearable severe pain.The clinical evaluation was "0–2" as "excellent", "3–5" as "good", "6–8" as "acceptable", and ">8" as "poor". "6 to 8" was categorized as "acceptable", and > 8" was categorized as "poor".

Statistical analysis

The data were analyzed using SPSS 26.0 statistical software, and the measurement data conforming to normal distribution were expressed as mean ± standard deviation (± s), and t-test was used for comparison between groups, while the comparison of count data was analyzed by X² test/continuous corrected test/Fisher's exact test.A multifactorial regression model was used to assess the influencing factors associated with operative time and intraoperative bleeding. P < 0.05 was considered a statistically significant difference.

Baseline demographics and clinical characteristics

In this study, we screened 95 patients who underwent myomectomy at the Second People's Hospital of Changzhou City, affiliated with Nanjing Medical University, from March 2020 to September 2023, of whom 4 were excluded (age > 70 years, n = 1; BMI ≥ 35 kg/m2, n = 1; preoperative HB < 80 g/L, n = 2) (Fig. 1).A total of 91 patients who met the study criteria were included in this study (Table 1).Forty-one patients were operated on using the "suture formula" and 50 patients were operated on using the "traditional randomized suture pattern".Table 1 summarizes baseline demographic and clinical characteristics.In the "suture formula" group, age ranged from 26 to 55 years, with a mean of 41.12 ± 6.38 years; BMI ranged from 18.36 to 29.97 kg/m2, with a mean of 23.12 ± 2.95 kg/m2; maximum tumor diameter ranged from 4 to 9.7 cm, with a mean of 6.25 ± 1.42 cm. Tumor maximum diameter 4ཞ9.7 cm, mean (6.25 ± 1.42) cm. pregnancy 0ཞ7 times, mean (2.73 ± 1.66) times. Labor 0 to 4 times, mean (1.34 ± 0.91) times. The number of fibroids was single in 31 cases and multiple in 10 cases. The location of fibroid was anterior wall in 17 cases, posterior wall in 18 cases and both anterior and posterior wall in 6 cases. 1 case was combined with hypertension, 1 case was combined with diabetes mellitus, 8 cases were combined with mild anemia and 3 cases were combined with moderate anemia.In the "traditional randomized suture" group, age ranged from 27 to 55 years, with a mean of 42.58 ± 7.11 years; BMI ranged from 18.14 to 32.05 kg/m2, with a mean of 23.44 ± 3.13 kg/m2; maximum diameter of the tumor ranged from 3 to 12 cm, with a mean of 6.11 ± 1.78 cm; pregnancy ranged from 0 to 6 times, with a mean of 2.32 ± 1.25 times. Tumor maximum diameter 3 to 12 cm, mean (6.11 ± 1.78) cm. pregnancy 0 to 6 times, mean (2.32 ± 1.25) times. Labor 0ཞ2 times, average (1.06 ± 0.42) times. The number of fibroids was 33 cases with single tumor and 17 cases with multiple fibroids. The location of fibroid was anterior wall in 23 cases, posterior wall in 18 cases, and both anterior and posterior wall in 9 cases. 3 cases were combined with hypertension, 1 case was combined with diabetes mellitus, 9 cases were combined with mild anemia, and 2 cases were combined with moderate anemia.All surgeries were performed by the same group of surgeons, and there was no statistically significant difference in basic information such as age, BMI, number of pregnancies and births, maximum diameter of tumor, number of leiomyosarcomas, location, and comorbidities between the two groups (P > 0.05).

Table 1

Comparison of general information of patients in both groups(\(\:\overline{\text{x}}\)±s)
Variant		"Suture formula" group(n = 41)	"Traditional randomized suture" group(n = 50)	t/X²	P
Age		41.12 ± 6.38	42.58 ± 7.11	−1.018	0.311
BMI(kg/m2)		23.12 ± 2.95	23.44 ± 3.13	−0.503	0.616
Number of pregnancies		2.73 ± 1.66	2.32 ± 1.25	1.312	0.194
Number of deliveries		1.34 ± 0.91	1.06 ± 0.42	1.822	0.074
Maximum tumor diameter (cm)		6.25 ± 1.42	6.11 ± 1.78	0.405	0.686
Number of fibroids	Single	31	33	0.997	0.318a
Number of fibroids	Numerous	10	17	0.997	0.318a
Fibroids Location	Front wall	17	23	0.616	0.735a
	Back wall	18	18
	Front and back walls	6	9
Combined high blood pressure	Yes	1	3	0.096	0.756b
Combined high blood pressure	No	40	47	0.096	0.756b
Combined diabetes	Yes	1	1	-	1.0c
Combined diabetes	No	40	49	-	1.0c
Combined mild anemia	Yes	8	9	0.034	0.854a
Combined mild anemia	No	33	41	0.034	0.854a
Combined moderate anemia	Yes	3	2	0.052	0.819b
Combined moderate anemia	No	38	48	0.052	0.819b

aPearson’s X² test.

bContinuity correction X² test.

cFisher’s exact test.

Comparison of intraoperative relevant indicators

Surgical time in the "suture formula" group ranged from 50 to 200 min, with a mean of (104.02 ± 44.18) min, and in the "traditional randomized suture" group ranged from 30 to 230 min, with a mean of (125.60 ± 46.13) min. Surgical time in the "suture formula" group was significantly less than that in the "traditional randomized suture" group (P < 0.05).Intraoperative bleeding in the "suture formula" group ranged from 10 to 500 ml, with a mean of (52.44 ± 81.02) ml. Intraoperative bleeding in the "traditional randomized suture" group ranged from 10 to 500 ml, with a mean of (93.60 ± 83.90) ml. The intraoperative bleeding in the "suture formula" group was significantly less than that in the "traditional randomized suture" group (P < 0.05) (Table 2).

Table 2

Comparison of intraoperative related indexes between the two groups of patients
Variant	"Suture formula" group(n = 41)	"Traditional randomized suture" group(n = 50)	t	P
Surgical time (min)	104.02 ± 44.18	125.60 ± 46.13	−2.262	0.026
Intraoperative bleeding (ml)	52.44 ± 81.02	93.60 ± 83.90	−2.365	0.020

Comparison of relevant indicators in the early postoperative period

The hemoglobin decrease in the "suture formula" group ranged from 1 to 15 g/L, with a mean of (5.98 ± 3.98) g/L. The hemoglobin decrease in the "traditional randomized suture" group ranged from 0 to 17 g/L, with a mean of (8.02 ± 3.85) g/L. The hemoglobin decrease in the "suture formula" group was significantly smaller than that in the "traditional suture" group (P < 0.05). The decrease in hemoglobin in the "suture formula" group was significantly smaller than that in the "traditional randomized suture" group (P < 0.05).In the "suture formula" group, the number of days of postoperative hospitalization ranged from 3 to 9, with a mean of (4.85 ± 1.22) days. Postoperative time to first anal defecation ranged from 18 to 79 h, mean (25.24 ± 9.72) h. Postoperative 12h VAS score 0 to 3, mean (1.44 ± 0.67). Postoperative 24h VAS score 1 to 3, mean (1.41 ± 0.63)." In the "traditional randomized suture" group, postoperative hospitalization ranged from 3 to 12 days, with a mean of (4.98 ± 1.45) days. Postoperative time to first anal defecation ranged from 18 to 32 h, with a mean of (23.16 ± 3.56) h. Postoperative 12h VAS score ranged from 0 to 3, with a mean of (1.58 ± 0.70). Postoperative 24h VAS score 1 to 3, mean (1.34 ± 0.62)." There was no significant difference between the "suture formula" group and the "traditional randomized suture" group in the number of days of postoperative hospitalization, the time of the first postoperative anal defecation, the 12h postoperative VAS score, and the 24h postoperative VAS score (P > 0.05) (Table 3).

Table 3

Comparison of relevant indicators in the early postoperative period between the two groups of patients
Variant	"Suture formula" group(n = 41)	"Traditional randomized suture" group(n = 50)	t	P
Hemoglobin drop value (g/L)	5.98 ± 3.98	8.02 ± 3.85	−2.482	0.015
Post-operative hospitalization days	4.85 ± 1.22	4.98 ± 1.45	−0.444	0.658
Time to first postoperative anal defecation (h)	25.24 ± 9.72	23.16 ± 3.56	1.303	0.199
12h postoperative VAS score	1.44 ± 0.67	1.58 ± 0.70	−0.971	0.334
24h postoperative VAS score	1.41 ± 0.63	1.34 ± 0.62	0.564	0.575

Comparison of intraoperative and early postoperative complications

One case of intraoperative hemorrhage, one case of postoperative fever, and one case of postoperative bowel obstruction occurred in the "suture formula group". In the "traditional randomized suture" group, there was one case of intraoperative hemorrhage, one case of intraoperative injury to adjacent organs, two cases of postoperative fever, and one case of poor healing of postoperative umbilical incision. There was no significant difference in the overall complication rate as well as the rates of each intraoperative and postoperative complication between the two groups (P > 0.05) (Table 4).

Table 4

Comparison of surgical complications between the two groups
Variant			"Suture formula" group(n = 41)	"Traditional randomized suture" group(n = 50)	P
Complications (total)		Yes	3	5	0.938b
Complications (total)		No	38	45	0.938b
Intraoperative complications (total)		Yes	1	2	1.0b
Intraoperative complications (total)		No	40	48	1.0b
Intraoperative complications	haemorrhage	Yes	1	1	1.0c
	haemorrhage	No	40	49	1.0c
	Adjacent organ damage	Yes	0	1	1.0c
	Adjacent organ damage	No	41	49	1.0c
Early postoperative complications (total)		Yes	2	3	1.0b
Early postoperative complications (total)		No	39	47	1.0b
Early postoperative complications	Fever	Yes	1	2	1.0b
	Fever	No	40	48	1.0b
	Intestinal obstruction	Yes	1	0	0.451c
	Intestinal obstruction	No	40	50	0.451c
	Poor healing of the umbilicus	Yes	0	1	1.0c
	Poor healing of the umbilicus	No	41	49	1.0c

aPearson’s X² test.

bContinuity correction X² test.

cFisher’s exact test.

Multivariate analysis of operative time in uniportal laparoscopic myomectomy for uterine fibroid removal

We performed a multivariate regression analysis of the factors associated with the surgical time of single-port laparoscopic myomectomy, constructing a model using the following variables that may affect the surgical time: suture pattern, age, number of leiomyomas, location of leiomyomas, maximum diameter of the tumor, BMI, number of pregnancies, number of deliveries, comorbidity with hypertension, comorbidity with diabetes mellitus, comorbidity with mild anemia, and comorbidity with moderate anemia.We found that "suture formula" (Beta: -19, 95% CI: -37, -0.62, P = 0.043) was a protective factor associated with operative time, multiple leiomyosarcomas (Beta: 43, 95% CI: 16, 69, P = 0.002) was a risk factor affecting operative time, tumor maximum diameter (Beta: 6.2, 95% CI: 0.53, 12, P = 0.032), and BMI (Beta: 4.0, 95% CI: 0.72, 7.4, P = 0.018) were the influencing factors of surgery time (Table 5).

Table 5

Multifactorial analysis of operative time in single-port laparoscopic myomectomy for uterine fibroid removal
Variant		Surgical time (min)
Variant		Beta	95% CI	P
Suture pattern	"Traditional randomized suture" group	—	—	—
Suture pattern	"Suture formula" group	-19	-37, -0.62	0.043
Age		0.15	-1.2, 1.5	0.8
Number of fibroids	Single	—	—	—
Number of fibroids	Numerous	43	16, 69	0.002
Fibroids Location	Front wall	—	—	—
	Back wall	-1.4	-20, 18	0.9
	Front and back walls	-32	-67, 3.8	0.080
Maximum tumor diameter		6.2	0.53, 12	0.032
BMI		4.0	0.72, 7.4	0.018
Number of pregnancies		6.7	-0.37, 14	0.063
Number of deliveries		-12	-27, 3.9	0.14
Combined high blood pressure	No	—	—	—
Combined high blood pressure	Yes	-4.6	-56, 47	0.9
Combined mild anemia	No	—	—	—
Combined mild anemia	Yes	21	-3.8, 46	0.10
Combined moderate anemia	No	—	—	—
Combined moderate anemia	Yes	26	-14, 66	0.2
Combined diabetes	No	—	—	—
Combined diabetes	Yes	-3.3	-67, 61	> 0.9

Multivariate analysis of intraoperative bleeding during single-port laparoscopic myomectomy

We performed a multivariate regression analysis of the factors associated with intraoperative bleeding in single-port laparoscopic myomectomy, constructing a model using the following variables that may affect intraoperative bleeding: suture pattern, age, number of leiomyomas, location of leiomyomas, maximum diameter of the tumor, BMI, number of pregnancies, number of deliveries, comorbid hypertension, comorbid diabetes mellitus, comorbid mild anemia, and comorbid moderate anemia.We found that the "suture formula" (Beta: -46, 95% CI: -81, -11, P = 0.011) was a protective factor related to the amount of intraoperative hemorrhage, and that the maximum diameter of the tumor (Beta: 13, 95% CI: 1.5, 24, P = 0.027) was an influencing factor on the amount of intraoperative hemorrhage ( Table 6).

Table 6

Multifactorial analysis of intraoperative bleeding in single-port laparoscopic myomectomy
Variant		Intraoperative bleeding (ml)
Variant		Beta	95% CI	P
Suture pattern	"Traditional randomized suture" group	—	—	—
Suture pattern	"Suture formula" group	-46	-81, -11	0.011
Age		2.5	-0.17, 5.3	0.066
Number of fibroids	Single	—	—	—
Number of fibroids	Numerous	9.7	-42, 61	0.7
Fibroids Location	Front wall	—	—	—
	Back wall	-1.3	-39, 36	> 0.9
	Front and back walls	2.8	-67, 72	> 0.9
Maximum tumor diameter		13	1.5, 24	0.027
BMI		-0.60	-7.1, 5.9	0.9
Number of pregnancies		8.6	-5.3, 22	0.2
Number of deliveries		4.5	-26, 35	0.8
Combined high blood pressure	No	—	—	—
Combined high blood pressure	Yes	-49	-150, 51	0.3
Combined mild anemia	No	—	—	—
Combined mild anemia	Yes	46	-2.3, 95	0.061
Combined moderate anemia	No	—	—	—
Combined moderate anemia	Yes	10	-68, 89	0.8
Combined diabetes	No	—	—	—
Combined diabetes	Yes	36	-89, 161	0.6

Uterine fibroids are the most common benign tumors of the female reproductive system, with a prevalence of up to 75% in women of childbearing age, and the likelihood of fibroids in postmenopausal women decreasing significantly[11].Its occurrence is associated with a variety of factors, such as genetics, estrogen, progesterone, childlessness, sexual disharmony, etc[12].For patients with infertility caused by uterine fibroids, repeated miscarriages, large or fast-growing fibroids, and ineffective conservative treatments, myomectomy can be the first choice of treatment, providing effective treatment for the disease while preserving fertility[13].Depending on the surgical access, it can be categorized into open and minimally invasive surgery.With the development of minimally invasive concepts, the surgical approach for myomectomy has gradually evolved from traditional open surgery to today's popular transumbilical single-port laparoscopic surgery.Single-port laparoscopic surgery has the advantages of less trauma, faster recovery, better cosmetic results and fewer complications than traditional multi-port laparoscopic surgery or open surgery[14].In spite of this, single-port laparoscopic surgery has greater operational difficulties and requires a longer learning cycle, which somewhat limits the development of single-port laparoscopic surgery.In single-port laparoscopic myomectomy, suturing of the trauma is a critical step in the procedure and a technical difficulty in this procedure.Suturing of the uterine wound requires frequent backstitching and thread winding, which tests the surgeon's skill even more in a single-port operation.A study showed that single-port laparoscopic surgery was prone to longer operative times compared with conventional multi-port laparoscopic surgery, but had a significant advantage in terms of observables such as postoperative pain scores, days of hospitalization, and incision satisfaction[15].

In single-port laparoscopic myomectomy, the efficiency of suturing the uterine wound affects the overall outcome of the procedure[16].Frequent additional suture hemostasis operations prolong the duration of the procedure, have an impact on the operator's state of mind, and increase the potential risks of the procedure.In conventional single-port laparoscopic myomectomy, the lack of exploration of uterine incision selection as well as techniques for single-port laparoscopic suturing methods has slowed the development of this procedure in recent years.

Our team performed the first single-port laparoscopic myomectomy in 2012, peaked in single-port laparoscopic myomectomy volume in 2017–2020, and has survived the initial learning phase in the learning curve of single-port laparoscopic myomectomy over the past nearly 10 years of exploration and practice.In order to improve the surgical efficiency of single-port laparoscopic myomectomy, in early 2022, our team summarized the suture pattern based on the concept of minimally invasive without adding any abdominal wall trauma, and proposed the "suture formula" operation technique.The results of this study showed that the operative time, intraoperative bleeding, and hemoglobin drop in the "suture formula" group were less than those in the "traditional randomized suture" group (P < 0.05), and the differences in postoperative hospital days, postoperative time to first anal evacuation, postoperative 12h VAS score, and postoperative 24h VAS score were not significant (P > 0.05).This demonstrates that the intraoperative use of the "Suture Formula" technique is feasible, does not increase the risk of surgery, and can significantly shorten the operation time, improve the efficiency of the operation, thereby reducing the amount of intraoperative bleeding and increasing the safety of the operation.In the "suture formula" group, intraoperative hemorrhage occurred in 1 case (2.4%), postoperative fever in 1 case (2.4%), and postoperative intestinal obstruction in 1 case (2.4%); in the "traditional randomized suture" group, intraoperative hemorrhage occurred in 1 case (2%), injury to adjacent organs in 1 case (2%), postoperative fever in 2 cases (4%), and poor healing of the umbilicus in 1 case (2%).The difference in intraoperative and postoperative complications between the two groups was not statistically significant (P > 0.05).This demonstrates that the intraoperative use of the "suture formula" is safe, does not increase the incidence of complications, and does not affect the short-term outcome of the patient.

In addition, we performed a multifactorial analysis of operative time and intraoperative bleeding in single-port laparoscopic myomectomy.The results of the study showed that suture pattern was an influencing factor for operative time (Beta: -19, 95% CI: -37, -0.62, P = 0.043) and intraoperative bleeding (Beta: -46, 95% CI: -81, -11, P = 0.011), which could shorten the operative time and reduce the amount of intraoperative bleeding.At the same time, the number of leiomyosarcomas (Beta: 43, 95% CI: 16, 69, P = 0.002), the maximum diameter of the tumor (Beta: 6.2, 95% CI: 0.53, 12, P = 0.032), and the BMI (Beta: 4.0, 95% CI: 0.72, 7.4, P = 0.018) were also the factors influencing the duration of the operation, and the maximum diameter of the tumor (Beta: 13, 95% CI: 1.5, 24, P = 0.027) were also influential factors for intraoperative bleeding.

The results of this study preliminarily show that the use of the "suture formula" technique in single-port laparoscopic myomectomy is safe and effective, improves the efficiency of intraoperative suturing, reduces intraoperative hemorrhage, and achieves a satisfactory clinical outcome.However, the study still has some limitations, and there is some bias due to the retrospective analysis and limited number of cases.Although there were no significant differences in baseline demographics between the two groups, it was still not possible to control for differences in patient selection.Although the "suture formula" technique is only a conceptual innovation, with no increase in abdominal wall trauma, no change in surgical access, and no special requirements for surgical instruments, skilled use of the formula still requires a certain degree of basic skills in laparoscopic suturing and single-port surgery.In terms of case selection, the feasibility of performing a longitudinal uterine incision needs to be met as much as possible, and there may be some limitations to the use of uterine fibroids in specific areas.This suturing technique is still in the exploratory stage, and the operator still needs to be flexible if additional intraoperative maneuvers such as hemostasis are required.

Although traditional transumbilical single-port laparoscopic myomectomy has a beautiful incision and high patient satisfaction, the operation time is long and the efficiency of the operation is low.The use of the "Suture Formula" technique conceptualizes the intraoperative selection of uterine incisions and suture steps, which reduces the difficulty of the procedure and, while ensuring hemostasis, reduces the need for unnecessary intraoperative backstitching and thread wrapping, thus shortening the operative time, improving the efficiency of the procedure, and reducing the potential risks.The use of this suturing technique does not increase the surgical risk as well as the incidence of surgical complications compared to conventional single-port laparoscopic myomectomy.This suture pattern provides a new breakthrough in single-port laparoscopic myomectomy.

Ethical approval

This surgical procedure was approved by the Ethics Committee of the Second People's Hospital of Changzhou, Affiliated to Nanjing Medical University（2017-Y-15-01）.

Consent

All patients signed a written informed consent.

Sources of funding

Funded by China Medical and Health Care Development Foundation（BJ2023YCPYJH003）；Changzhou Health Talent Overseas Training Grant Program（GW2023024）；Changzhou “14th Five-Year Plan” High-level Talent Cultivation Project for Healthcare（2022CZBJ074）；Jiangsu Province Maternal and Child Health Key Talent Program（RC202101）；Maternal and Child Health Research Program in Jiangsu Province（F202138）；Jiangsu Postdoctoral Research Funding Program(2019K064) ；Jiangsu Province “333 Project” Scientific Research Funding Program(BRA2019161).

Author contribution

YW,QJ,HT and JC: data curation, investigation, methodology, formal analysis, writing – original draft; YW,QJ,HT and WC: data curation, investigation, methodology, software, visualization; YW,QJ,HT and YY: data curation and investigation; YW,QJ,HT and WW: conceptualization, writing – review and editing; YW,QJ,HT and BT: conceptualization, methodology, and visualization; YW,QJ,HT and JC: conceptualization, investigation, methodology, resources, project administration, writing – review and editing.

Conflicts of interest disclosure

The authors declare that they have no known competing interests or personal relationships that could have appeared to influence the work reported in this paper.

Research registration unique identifying number

The trial was registered by Research Registry with a unique identification number (researchregistry10369).

Data availability statement

Data used for this research are available from corresponding author upon request. All authors confirm its originality and bear responsibility of postproduction queries.

Provenance and peer review

Not commissioned, externally peer-reviewed.

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No competing interests reported.

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The proposal and application of the "Suture Formula" make single port laparoscopic myomectomy simpler and more efficient: a retrospective cohort study

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Abstract

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Highlights

Introduction

Materials and methods

Study population

Surgical procedure of myomectomy under LESS with"suture formula"

Surgical procedure of traditional single-port laparoscopic myomectomy

Data collection

Outcome

Statistical analysis

Result

Baseline demographics and clinical characteristics

Comparison of intraoperative relevant indicators

Comparison of relevant indicators in the early postoperative period

Comparison of intraoperative and early postoperative complications

Multivariate analysis of operative time in uniportal laparoscopic myomectomy for uterine fibroid removal

Multivariate analysis of intraoperative bleeding during single-port laparoscopic myomectomy

Discussion

Conclusions

Declarations

References

Additional Declarations

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