Robotic-Assisted Surgery in Pediatric Gynecology: Preliminary Initial Outcomes

doi:10.21203/rs.3.rs-4960065/v1

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Robotic-Assisted Surgery in Pediatric Gynecology: Preliminary Initial Outcomes

https://doi.org/10.21203/rs.3.rs-4960065/v1

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Introduction

Robotic-assisted surgery has become widely used in adult gynecology, but has not yet been widely used in pediatric patients. We report our initial experience in robot-assisted pediatric gynecologic surgery to determine its feasibility, safety and limitations in children.

Methods

A retrospective single-center study was performed among consecutive girls under 18-years who underwent ginecologic robotic-assisted procedures in our institution between 2012-2021. A three-arm robot (5 mm trocars) with one camera arm (12 mm trocar) was used in all cases by the same surgical team. Demographic data, type of robotic procedure, surgery time, complication rate, conversion rate to laparoscopic procedure, lenght of hospital stay (LOS) and postoperative complications were analyzed.

Results

A total of 10 patients were included (median age 11.9 years; range 2.5-17.4 years), who underwent robotic assisted surgery for adnexal pathologies: 3 for ovarian cystectomy, 3 for ovarian teratoma resection, 2 for oophorectomy, 1 for bilateral salpingo-oophorectomy for gonadal dysgenesis and 1 for hysterectomy in a patient with cerebral palsy and recurrent severe uterine bleeding. Median surgery time was 74 minutes (interquartile range: 66-82 minutes). Intraoperative blood loss was minimal (median: 35 ml) Conversion to laparatomy was not necessary in any case. Median LOS was 1 day (interquartile range: 1-2 days). No intra- or postoperative complications occurred.

Conclusion

Preliminar outcomes indicate that ginecologic robotic-assisted surgery is effective and safely applicable in the pediatric population. However, it is still too early to conclude that it provides better clinical outcomes than traditional laparoscopic surgery. Further prospective, comparative studies are still needed.

Type of study: Observational retrospective study

Level of evidence: IV

robotic surgery

children

gynecological surgery

ovarian sparing surgery

oophorectomy

In the last decade, robotic-assisted surgery has become widely used in different surgical specialties such as gynecology, urology and general surgery, mainly in adult patients (1, 2). In children, robotic surgery has mainly focused on urology and general surgery, where different applications have been described (3–7), but has not yet been widely used in pediatric gynecology.

Although many studies have illustrated that robotic-assisted surgery can be used safely to perform adnexal and pelvic surgery in adult women, only a few cases in the area of paediatric gynaecologic surgery have been described (8–11). The aim of this study is to report our initial experience in robot-assisted pediatric gynecologic surgery to determine its feasibility, safety and limitations in children.

A retrospective single-center study was performed among consecutive girls under 18-years who underwent ginecologic robotic-assisted procedures in our institution between 2012–2021. Robotic device Da Vinci Si® was used in all cases. A two-arm robot (5-mm trocars) with one camera arm (12-mm trocar) was used in all procedures by the same surgical team.

Demographics, clinical features (type of gynecologic lesion, abdominal pain, history of previous ovarian torsion and radiological size of the lesion), intraoperative data (blood loss, intraoperative complications, conversion to open surgery and surgery time), length of hospital stay (LOS), postoperative complications, and follow-up outcomes were analyzed. Preoperative ultrasonography and/or MRI showed the longitudinal diameter of the ovarian lesion. In patients with ovarian or adnexal masses, laboratory quantification of tumor hormone markers was performed (CA-125, CA-19.9, human chorionic gonadotropin [hCG] and alpha-fetoprotein [AFP]). Intraoperative blood loss was assessed by quantifying the volume of blood aspirated into the suction system tube (measured in milliliters). Follow-up appointments were conducted regularly in the outpatient clinic for all patients following discharge with subsequent imaging surveillance. The study design and collection of patient data were carried out with approval from the Institutional Review Board (IRB number 1945724-1).

All interventions were performed under general anesthesia. Foley catheters were consistently placed in all patients as part of the standard procedure. Trocars were inserted while patients were in the supine position. In small girls with a narrow waist, the trocars were introduced as little as necessary for the robot to recognize them inside the patient, and thus achieve greater working space for the movement of the robotic instruments. Subsequently, the robotic cart was positioned at the foot end of the operating table, and before docking the patient was placed in Trendelemburg position with the legs slightly open, to allow for increased space in the pelvis. Da Vinci Si® robot, unlike the posterior Xi® model, does not allow the arms to rotate, so in pelvic surgeries it always has to enter from the patient's feet. Figure 1 shows the strategic operating room setup of the elements in the gynecological robotic procedures.

A single 12-mm trocar was utilized at the umbilicus to accommodate the 3D, 30º, robotic telescope. Additionally, two 5-mm working trocars were employed to accommodate the robotic instruments, such as bipolar fenestrated forceps, scissors, and a mopopolar hook. Before introducing the 12-mm umbilical trocar telescope, the sites for the working trocars were marked to optimize angulation and working space for the robotic arms. The 5-mm trocars were then inserted after insufflating with CO2 to a pressure ranging between 12–14 mm Hg. The main surgeon conducted the operations from the robotic console, while a surgical assistant positioned at the patient's side switched the different robotic instruments on the working trocars. All resected specimens were extracted by endobag through the umbilical incision and were sent for histological analysis.

Analysis of the data was conducted using Microsoft Excel software (version 2010, Washington, USA) and SPSS Statistics (version 23, Illinois, USA). Categorical variables were expressed as percentages (%) and frequency (n). The distributions of numerical variables were assessed using the Shapiro-Wilk and Kolmogorov-Smirnoff tests. Non-normally distributed continuous variables were presented as medians and interquartile range (IQR), while normally distributed continuous variables were reported as means and standard deviation.

A total of 10 patients were included, with a median age of 11.9 years (range of 2.5–17.4 years and IQR of 8.7–10.2 years), who underwent robotic assisted surgery for several adnexal pathologies: 3 for ovarian cystectomy, 3 for ovarian teratoma resection, 2 for total oophorectomy in lesions with elevated hormone markers, 1 for bilateral salpingo-oophorectomy in a patient with gonadal dysgenesis (chromosomal anomaly with XXY karyotype) and 1 for hysterectomy in a patient with cerebral palsy and recurrent severe uterine bleeding. Six of the patients (60%) were post-menarchal. In most cases the diagnosis was made by abdominal ultrasound in the context of abdominal pain. MRI was performed when the ultrasound diagnosis was not clear. The mean radiological diameter of the lesions was 5.5 ± 1.2 cm (range 2.5–13 cm). Two patients (one with an ovarian cyst and one with a teratoma) had previous episode of ovarian torsion, which required urgent surgical intervention to detorsion, and subsequently underwent scheduled surgery a few months later.

Regarding intraoperative data, all procedures were elective. Ovarian sparing surgery (OSS) was performed in 6 patients (3 solid teratoma and 3 ovarian cysts) in order to preserve healthy ovarian tissue in lesions with high suspicion of benignity. Total oophorectomy was performed in 2 patients with elevated tumor markers in whom pathological anatomy identified as immature teratoma. Median surgery time was 74 minutes (interquartile range: 66–82 minutes). No intraoperative complications were reported. No intraoperative bleeding or organ damage took place. In all cases bipolar forceps were used to perform hemostasis on the ovarian tissue. Intraoperative blood loss was minimal (median 35 ml and IQR 25–50 ml). Conversion to laparoscopy or laparatomy was not necessary in any case. Median LOS was 1 day (interquartile range: 1–2 days). No postoperative complications occurred and no postoperative blood transfusions were needed. After discharge, no intra-abdominal or trocar wound complications were reported. The histological result determined the definitive diagnosis. No signs of atypia or malignancy were found in any of the specimens analyzed. During long-termn follow-up (median time: 5.4 years; IQR: 3.7–8.6 years), no readmissions or surgical reinterventions were reported for this reason, with a satisfactory esthetic result in all cases. Table 1 outlines clinical data of the patients along with the procedures conducted.

In this study we discuss our preliminary experience using robotic surgery in gynecologic procedures in pediatric patients. Despite the limited number of patients who underwent surgery, the initial outcomes are promising. Robotic-assisted gynecological procedures with Da Vinci system shows full applicability in gynecological surgery in pediatric patients, with satisfactory results and no adverse effects in the medium to long term.

While the robotic device for gynecologic surgery received approval from the Food and Drug Administration in 2005, it remains in its early stages compared to other surgical approaches (12). In adult patients, robotic use for benign gynecologic procedures has has shown feasibility, safety, and comparable clinical outcomes to traditional laparoscopy, with superior outcomes compared to laparotomy (1). However, most of the experience has been reported in adult patients, due to a higher incidence of gynecologic disease compared to the pediatric population, resulting in few studies in children. In our experience, the robotic approach has a number of advantages over the laparoscopic approach, which facilitate the surgical procedure in complex and narrow anatomical areas such as the pelvis. We gained improved dexterity, coordination, and improved visualization with three-dimensional technology and increased magnification. The absence of intraoperative and postoperative complications also support the safety and feasibility of this approach in children. Innovations like three-dimensional capabilities have shown reduced error rates and faster task completion times compared to laparoscopy (13). There have also been reports of decreased physical and mental strain compared with laparoscopy (14).

Benign mature ovarian teratoma stands as the most prevalent ovarian tumor encountered in children, often necessitating surgical intervention (15, 16). Nonetheless, undergoing unilateral oophorectomy at a young age could potentially lead to a reduced reproductive lifespan and premature onset of menopause (17). In recent years, the importance of multidisciplinary collaboration between pediatric surgeons and gynecologists to promote ovarian preservation surgery in lesions with a high probability of being benign has been highlighted (18). One of the remaining challenges is to identify methods for accurate preoperative risk stratification of these lesions. Recent studies have identified a constellation of physical examination findings, imaging and laboratory tests that can help clinicians accurately differentiate between benign and malignant disease prior to surgery (19). Laparoscopic surgery is currently considered the gold standard for managing benign ovarian tumors because it associated benefits such as shorter hospital stays, reduced postoperative pain, quicker recovery periods, and lower rates of adhesion formation compared to open surgical methods (20). However, laparoscopic ovarian sparing surgery may have difficulty peeling off the cyst wall completely because of poor visual field stability and amplification of tremors, requires a long learning curve and leads to earlier surgeon fatigue (21, 22). All these drawbacks can be solved by the robotic approach, which allows a more precise dissection of the ovarian masses, which can decrease the risk of rupture. In addition, it requires a shorter learning curve and reduces surgeon fatigue, since the surgeons are seated during console time (23). Other less common gynecologic procedures in pediatric patients such as total oophorectomy or salpingo-oophorectomy also benefit from the robotic approach for the same reasons. Careful dissection of the vascular pedicles minimizes the risk of bleeding. Increased degree of movement and augmented precision also allows resection of neoplastic implants in the pelvis if they are found during the procedure. Finally, although hysterectomy is not a procedure commonly performed in children, the robotic approach has demonstrated advantages over the laparoscopic approach. (2). The unique patient in our series had a history of recurrent endometrial bleeding refractory to medical treatment in a 12-year-old girl with cerebral palsy, for which the surgical indication was consented with her family. The intervention was performed alongside members of the adult gynecology team, due to their greater experience in this type of procedure.

Gynecologic robotic surgery in pediatric patients has some unique peculiarities compared to adult surgery. In all procedures we only use 3 trocars, while in adults 4 trocars are normally required. Trendelemburg position allows us to clear the pelvis of bowel loops, to avoid placing an accessory arm to separate them. In large ovarian masses, we use rotation of the table to the opposite side of the lesion to achieve better exposure of the ovary. We avoid placing a fourth arm, because as it will require more space and interfere with the operation of other arms in the pelvis, thereby increasing difficulty of the manipulation of the other arms. Trocars position is essential to achieve an adequate range of motion with robotic instruments. (24). Some authors measure the distance between the anterior superior iliac spine, and consider at least 13 cm the necessary distance for the performance of these procedures by robotic approach (25). However, this gap is difficult to achieve in infant patients or in girls with narrow waists. We have previously shown that pelvic robotic surgery is safe and effective in patients under 12 months of age (26). For this reason we consider that the indications and contraindications for robotic surgery should be similar to those for laparoscopic surgery, regardless of the size and weight of the patient.

The limitations of this study are derived from its retrospective, single-center design. Despite the small sample size of our series, it is to the best of our knowledge, the largest ever carried to date. While our initial findings with robotic-assisted surgery in pediatric gynecology have shown considerable promising, it is still too early to determine whether the robotic approach offers superior clinical outcomes over traditional laparoscopic surgery in children. Further case-control and prospective comparative studies are needed to better understand the advantages of this new technology and its optimal applications in pediatric patients.

Preliminar outcomes indicate that ginecologic robotic-assisted surgery is effective and safely applicable in the pediatric population. This approach could be considered in infants and children regardless of their age and weight, in centers with an appropriate robotic training. However, it is still too early to conclude that it provides better clinical outcomes than traditional laparoscopic surgery. Further prospective, comparative studies are still needed.

Conflict of interest: The authors declare no conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding: No funding was provided for this study.

Ethics approval and consent to participate: This study obtained the approval of the institutional ethics committee and the institutional review board (IRB number 1945724-1). Child's parents signed a written informed consent form, which included the publication of the images of this case

Data availability statement: Data from this study are available upon reasonable and justified request to the authors.

Author Contribution

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by CDM, LR, WC, KD and JC. The first draft of the manuscript was written by CDM and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Truong MD, Tholemeier LN. Role of Robotic Surgery in Benign Gynecology. Obstet Gynecol Clin North Am. 2022;49:273-86.
Gitas G, Hanker L, Rody A, Ackermann J, Alkatout I. Robotic surgery in gynecology: is the future already here? Minim Invasive Ther Allied Technol. 2022;31:815-24.
Mattioli G, Lena F, Fiorenza V, Carlucci M. Robotic ureteral reimplantation and uretero-ureterostomy treating the ureterovesical junction pathologies in children: technical considerations and preliminary results. J Robot Surg. 2023;17:659-67.
Janssen KM, Kirsch AJ. Outcomes of complex robot-assisted laparoscopic ureteral reimplantation after failed ipsilateral endoscopic treatment of vesicoureteral reflux. J Pediatr Urol. 2021;17:547.e1-547.e6.
Bilgutay AN, Kirsch AJ. Robotic Ureteral Reconstruction in the Pediatric Population. Front Pediatr. 2019;7:85.
Delgado-Miguel C, Amarnath RP, Camps JI. Robotic-assisted vs. Laparoscopic Heller's Myotomy for Achalasia in Children. J Pediatr Surg. 2023:S0022-3468(23)00687-5
Delgado-Miguel C, Camps JI. Robotic-assisted versus laparoscopic redo antireflux surgery in children: A cost-effectiveness study. Int J Med Robot. 2023;19:e2541.
Nakib G, Calcaterra V, Scorletti F, et al. Robotic assisted surgery in pediatric gynecology: promising innovation in mini invasive surgical procedures. J Pediatr Adolesc Gynecol. 2013;26:e5-7.
Lima M, Maffi M, Di Salvo N, Ruggeri G, Libri M, Gargano T, Lardy H. Robotic removal of Müllerian duct remnants in pediatric patients: our experience and a review of the literature. Pediatr Med Chir. 2018;40(1).
Wong YS, Tam YH, Pang KKY, Chan SSC, Chu WCW. Robotic repair of congenital vesicovaginal fistula masquerading as a ureterocele in a 10-year-old girl. Urol Case Rep. 2018;20:48-50.
Xie XX, Wang N, Wang ZH, Zhu YY, Wang JR, Wang XQ. Robotic-assisted resection of ovarian tumors in children: A case report and review of literature. World J Clin Cases. 2019;7:2542-8.
Truong M, Kim JH, Scheib S, Patzkowsky K. Advantages of robotics in benign gynecologic surgery. Curr Opin Obstet Gynecol. 2016;28:304-10.
Shakir F, Jan H, Kent A. 3D straight-stick laparoscopy versus 3D robotics for task performance in novice surgeons: a randomised crossover trial. Surg Endosc. 2016;30:5380-7.
Hubert N, Gilles M, Desbrosses K, et al. Ergonomic assessment of the surgeon’s physical workload during standard and robotic assisted laparoscopic procedures. Int J Med Robotics Comput Assist Surg 2013;9:142-7.
Zhang M, Jiang W, Li G, Xu C. Ovarian masses in children and adolescents– an analysis of 521 clinical cases. J Pediatr Adolesc Gynecol. 2014;27:e73–7.
Łuczak J, Bagłaj M. Selecting treatment method for ovarian masses in children – 24 years of experience. J Ovarian Res. 2017;10:59.
Rosendahl M, Simonsen MK, Kjer JJ. The influence of unilateral oophorectomy on the age of menopause. Climacteric. 2017;20:540-4.
Abbas PI, Dietrich JE, Francis JA, Brandt ML, Cass DL, Lopez ME. Ovarian-Sparing Surgery in Pediatric Benign Ovarian Tumors. J Pediatr Adolesc Gynecol. 2016;29:506-10.
Lawrence AE, Minneci PC, Deans KJ. Ovary-sparing surgery for benign pediatric ovarian masses. Curr Opin Pediatr. 2019;31:386-90.
Seckin B, Ozdener T, Tapisiz OL, Batioğlu S. Laparoscopic treatment of ovarian cysts in adolescents and young adults. J Pediatr Adolesc Gynecol. 2011;245:300-3.
Laberge PY, Levesque S. Short-term morbidity and long-term recurrence rate of ovarian dermoid cysts treated by laparoscopy versus laparotomy. J Obstet Gynaecol Can. 2006;28:789-93.
Peters BS, Armijo PR, Krause C, Choudhury SA, Oleynikov D. Review of emerging surgical robotic technology. Surg Endosc. 2018;324:1636-55.
Morales-López RA, Pérez-Marchán M, Pérez Brayfield M. Current concepts in pediatric robotic assisted pyeloplasty. Front Pediatr. 2019;7:4.
Chang C, Steinberg Z, Shah A, Gundeti MS. Patient positioning and port placement for robot-assisted surgery. J Endourol 2014;28:631-8.
Finkelstein JB, Levy AC, Silva MV, Murray L, Delaney C, Casale P. How to decide which infant can have robotic surgery? Just do the math. J Pediatr Urol 2015;11:170.e1-170.e4.
Delgado-Miguel C, Camps JI. Robotic Soave pull-through procedure for Hirschsprung's disease in children under 12-months: long-term outcomes. Pediatr Surg Int. 2022;38:51-7.

No competing interests reported.

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Robotic-Assisted Surgery in Pediatric Gynecology: Preliminary Initial Outcomes

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Abstract

Figures

Introduction

Methods

Results

Discussion

Conclusion

Declarations

Author Contribution

References

Additional Declarations

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