Application of polidocanol foam injection sclerotherapy in patients with antithrombotic therapy combined with mixed hemorrhoid bleeding: A single-center experience and literature review

doi:10.21203/rs.3.rs-5025279/v1

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Application of polidocanol foam injection sclerotherapy in patients with antithrombotic therapy combined with mixed hemorrhoid bleeding: A single-center experience and literature review

https://doi.org/10.21203/rs.3.rs-5025279/v1

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Objective

To explore the single-center clinical experience of polydocanol foam in the antithrombotic treatment of mixed hemorrhoid patients with bleeding and review the related literature.

Methods

From March 2018 to May 2023, we retrospectively analyzed the clinical data of 7 patients who were admitted to the General Surgery Department of Yangpu Hospital affiliated to Tongji University. Patients with antithrombotic therapy combined with mixed hemorrhoid bleeding who failed to receive conservative treatment need to be treated with polydocanol foam injection sclerotherapy. We summarized the single-center clinical application experience of polydocanol foam injection sclerotherapy in the treatment of patients receiving antithrombotic therapy combined with mixed hemorrhoid bleeding. Through a literature search, the related literature results concerning the application of polydocanol foam sclerotherapy in the antithrombotic treatment of patients with mixed hemorrhoid bleeding were reviewed.

Results

Seven patients were successfully treated with polydocanol foam sclerotherapy, and the bleeding stopped. The operation time ranged from 10–30 minutes, and no serious complications occurred. At the 4-week postoperative follow-up evaluation, none of the patients had bleeding again, and hemoglobin significantly increased (Hb: 106.0 ± 17.4 g/L vs Hb: 70.9 ± 19.7 g/L). Four weeks after surgery, the overall clinical efficacy rate reached 100%, with a satisfaction rate of 100%. Through a literature review, three studies were ultimately included for analysis.

Conclusion

Polydocanol foam injection sclerotherapy is a safe and effective method for patients receiving antithrombotic therapy combined with mixed hemorrhoid bleeding. However, larger multicenter prospective studies are needed before this is the preferred treatment for such patients.

Health sciences/Gastroenterology/Gastrointestinal diseases/Anal diseases

Health sciences/Signs and symptoms/Digestive signs and symptoms

Polidocanol foam sclerotherapy

Antithrombotic therapy

Bleeding

Hemorrhoids

Hemorrhoid disease is one of the most common anorectal diseases in the clinic. In the United States, its incidence rate is 4%-55%[1], and more than 50% of the population aged over 50 years has hemorrhoid-related symptoms[2]. Research has shown that only 9.3% of symptomatic hemorrhoids require surgical treatment. However, for patients with hemorrhoids complicated by coagulation dysfunction, especially those who require the use of antithrombotic drugs for treatment, their hemorrhoids are characterized mainly by bleeding symptoms, and sometimes, bleeding is dangerous[3], which presents certain challenges in treatment. For this group of patients, stopping antithrombotic therapy increases the risk of thrombosis, continuing antithrombotic therapy makes it difficult to control internal hemorrhoid bleeding through conservative treatment, and traditional surgical treatment methods have a high risk of postoperative rebleeding and poor patient tolerance [4].

Injection sclerotherapy (IST), a minimally invasive treatment method, has shown good efficacy and safety in the treatment of internal hemorrhoids in recent years [5]. As a new sclerosant, some studies have shown that for patients receiving antithrombotic drug treatment, polydocanol foam injection treatment without stopping the drug has satisfactory hemostatic effects, and 99% of patients have no bleeding requiring special treatment [6]. The Chinese expert consensus on hemorrhoid injection therapy (2023 edition) also strongly recommends the use of polidocanol for the treatment of Grade I-III hemorrhoids and hemorrhoid bleeding [5].

The research team of the author started performing sclerotherapy with polydocanol foam in 2018 and has completed IST for 119 patients, with some clinical experience. On this basis, the research team of the author extended sclerotherapy with polydocanol foam to the antithrombotic treatment of mixed hemorrhoid patients with bleeding and achieved relatively ideal results. In this study, we conducted a retrospective analysis of single-center case data, shared treatment experiences, and summarized clinical experience. In addition, owing to the lack of relevant literature, we reviewed the literature to provide a reference for the application of polydocanol foam in the antithrombotic treatment of mixed hemorrhoid patients with bleeding. The report is as follows.

Patients

From March 2018 to May 2023, a total of 7 patients with mixed hemorrhoid bleeding who were treated with antithrombotic therapy but failed conservative treatment were admitted to the General Surgery Department of Yangpu Hospital affiliated with Tongji University. Among them, there were 4 males and 3 females, aged 62–98 years, with an average age of 80.1 ± 12.4 years. There were 6 patients with Grade III hemorrhoids and 1 patient with Grade II hemorrhoids. The reasons for their antithrombotic treatment were 2 cases due to cerebral infarction, 2 cases due to dialysis treatment in the late stage of chronic kidney disease, 1 case due to persistent atrial fibrillation, 1 case due to coronary stent implantation in coronary heart disease, and 1 case due to mitral valve replacement surgery.

This study was approved by the Ethics Committee of Yangpu Hospital of Tongji University (Yangpu District Central Hospital) (No. LL-2024–LW-015) and followed the precepts established by the Helsinki Declaration. The participants provided written informed consent to participate in this study. Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article.

Surgical methods

Patient Preparation

(1) Exclude contraindications (patients allergic to polidocanol, combined with incarcerated mixed hemorrhoids and other anorectal diseases (perianal abscess, anal fistula, anal fissure, rectal polyps, rectal cancer, etc.), internal hemorrhoids with thrombosis, entrapment, ulceration, infection, etc.);

(2) Routine digital rectal examination is performed to rule out other anal and rectal diseases;

(3) Empty stool before treatment, no need for intestinal preparation (recommended enemas for patients with constipation), and no need for anesthesia or prophylactic antibiotic use;

(4) The patient's condition should be communicated, and informed consent should be obtained before treatment.

Preparation of venue and equipment:

(1) Polydocanol IST can be performed in outpatient operating rooms/operating rooms without the need for monitoring equipment;

(2) Adult anoscope;

(3) Polydocanol 3% injection, three-way tube*1, 10 ml/20 ml syringe*2, 21G needle.

Preparation of polydocanol foam (Tessari technique)[7]

(1) Configuration proportion: A 10 ml syringe without silica gel (with a rubber plug) draws 8 ml of air, and another 10 ml syringe draws 2 ml of liquid sclerosant to make a 10 ml foam sclerosing agent (20 ml syringe draws multiple times);

(2) Configuration method: A three-way valve is used to connect these two syringes and rotate them to a 90-degree angle; the syringe is quickly injected until it reaches the end, promoting the mixing of air and sclerosants, and vice versa (10 times); the three-way valve is rotated to tilt it, and the two syringes are still connected, but the channel is closed; then, 10 back-and-forth injections are carried out to prepare white uniform fine foam-like sclerosants (Fig. 1A).

Injection therapy steps

(1) Position and disinfection: The patient is placed in a prone position with a folding knife, a lithotomy position, or a left lateral position. The surgical field of view is routinely disinfected, and sterile towels are laid in place;

(2) Anal examination: An anal endoscope is inserted to identify the distribution and size of the hemorrhoids;

(3) Precautions for IST: the injection should be started immediately after the successful preparation of polydocanol foam (delayed injection after the preparation of foam will lead to liquid accumulation and a decrease in the foam volume, which will affect the therapeutic effect [8]);

(4) Injection method: The injection site should be located at the base of the hemorrhoid above the dentate line, and the depth should be strictly controlled in the submucosal layer. The injection angle should include multiple angles (3, 7, and 11 directions and an obvious venous plexus). The injection volume should be determined according to the size and tolerance of the hemorrhoids until the hemorrhoids become larger and white (0.4–2 ml of sclerosant foam should be injected at each injection point, with a total amount of 2–10 ml, and the needles should be withdrawn during injection) (Fig. 1B and 1C).

(5) Postinjection treatment: After injection, the hemorrhoids were fully massaged to evenly distribute the sclerosants under the mucosa, and the wounds were covered with Vaseline gauze.

Postinjection efficacy evaluation and treatment course

(1) Efficacy evaluation: After the injection is complete, the patient is followed up for the fourth week to assess improvements in symptoms such as bleeding and prolapse and to evaluate the patient's efficacy. The definition of a cure is the disappearance of symptoms such as rectal bleeding, prolapse, or pain in the patient and the disappearance of varicose veins without serious complications. The definition of improvement was significant improvement in symptoms such as rectal bleeding and prolapse, significant reduction in varicose veins, and no serious complications. The definition of vitiation is as follows: clinical symptoms; the size of the hemorrhoids has not changed after treatment; and even the condition has worsened or is accompanied by serious complications. The definitions of serious complications are as follows: (a) bleeding that requires hospitalization for hemostasis and blood transfusion treatment; (b) severe pain that requires hospitalization for treatment; and (c) urinary retention requiring catheterization. The clinical total effective rate=(number of cured cases + number of improved cases)/total number of cases × 100% [9].

(2) Treatment course: If the patient's symptoms do not improve, IST can be performed again, with a recommended treatment interval of 2 weeks; if the patient does not improve after 4 treatments, it is recommended to switch to other treatment methods. All postoperative patients who underwent IST were routinely treated with anthemorrhoid suppositories and sodium aescinate tablets for 2 weeks.

Literature Review

The relevant literature on Web of Science was searched with the key words polydocanol and hemorrhoids, the retrieved literature was screened, and the relevant literature on the application of polydocanol foam in antithrombotic treatment of patients with hemorrhoid bleeding was summarized.

Seven patients were successfully treated with polydocharol foam injection for hemostasis. The operation time ranged from 10–30 minutes, with an average of 19.7 ± 8.2 minutes. When reexamination was conducted 4 weeks after the operation, none of the patients experienced rebleeding (Fig. 2). These 7 patients all had varying degrees of preoperative anemia (3 severe, 2 moderate, 1 mild, Hb 70.9 ± 19.7 g/L), but their postoperative hemoglobin levels significantly increased at 4 weeks (1 normal, 5 mild, 1 moderate, Hb 106.0 ± 17.4 g/L). After 4 weeks of postoperative follow-up, no patients experienced serious complications, with a total clinical efficacy rate of 100% and a satisfaction rate of 100% (Table 1). After one year of postoperative follow-up evaluation, only one patient experienced recurrence, which improved after IST was performed again.

Through the literature review, only 3 studies were eligible for inclusion, as shown in Table 2.

For patients receiving antithrombotic therapy combined with mixed hemorrhoid bleeding, given the increased risk of thromboembolism after discontinuation [10], continuous antithrombotic drug treatment not only increases the incidence of hemorrhoid bleeding [4] but also makes it difficult to control hemorrhoid bleeding. In addition, during conservative treatment, a decrease in hemoglobin, platelet, and coagulation function in patients with chronic recurrent bleeding not only increases the risk of anesthesia and operation [11] but also increases the risk of postoperative rebleeding [12]. Rubber band ligation (RBL) is the most commonly used treatment for hemorrhoidal bleeding, but for patients receiving antithrombotic therapy, there is a high risk of rebleeding on the ulcer surface after the ligation thread falls off [3, 13]. Therefore, guidelines from multiple countries do not recommend RBL treatment [14–18] but recommend treatments such as IST and interventional embolization. Among them, IST has good therapeutic effects, with an overall success rate of 93–98% in patients with Grade I–III hemorrhoids [6, 19]. Compared with RBL, it has a lower incidence of postoperative complications such as rebleeding and pain [19] and is safer in the treatment of patients with hemorrhoidal bleeding who are receiving antithrombotic therapy [20]. Therefore, it is recommended as the preferred therapy for drug-resistant low-grade bleeding hemorrhoids [21]. In addition, IST does not require anesthesia or bowel preparation and can be quickly treated for hemostasis in outpatient settings [6]. It not only has high reproducibility and cost-effectiveness but also high patient satisfaction [22].

The mechanism of IST for internal hemorrhoids is to inject sclerosants into the submucosa and nucleus of the hemorrhoids, producing a sterile inflammatory response that causes coagulation of the hemorrhoids, occlusion of hemorrhoid blood vessels, fibrosis and fixation of hemorrhoid tissue, thereby causing hemorrhoid atrophy and cessation of bleeding, reducing patients' stool and itching, and alleviating prolapse symptoms [23]. This treatment method not only conforms to the theory of prolapse of the anatomical anal cushions but also conforms to the principle of minimally invasive treatment for internal hemorrhoids, with the main goal of eliminating or reducing symptoms of hemorrhoids [14, 24, 25]. As a new sclerosant in recent years, polydocanol has been proven to have good efficacy and safety in the treatment of Grade I to III hemorrhoids and hemorrhoid bleeding [5, 8]. Compared with other sclerosants, polydocanol foam has good curative effects and high safety, and its effective rate is up to 94.7%-98.0% [6, 26], with a complication rate as low as 0.15%-1.50% [26, 27]. In addition, polidocanol also has a local anesthetic effect [28], which can alleviate pain during treatment and improve patient comfort and satisfaction [27]. Therefore, polidocanol has long been recommended for the treatment of varicose veins in the European Guidelines for the Treatment of Chronic Venous Disease [29]. In addition, sclerotherapy for Grade I-III hemorrhoids and hemorrhoid bleeding is strongly recommended by the Chinese Expert Consensus on Hemorrhoid Injection Therapy (2023 edition) [5].

The 7 patients we treated were all elderly patients with grade II-III mixed hemorrhoids who had undergone long-term antithrombotic therapy. They had undergone a long conservative treatment process and had varying degrees of anemia due to repeated bleeding, resulting in poor surgical tolerance. Therefore, we learned from the advantages of polydocanol foam in hemostasis, anesthesia and safety and conducted IST for these patients without anesthesia or preoperative intestinal preparation. The patients were satisfied with the treatment effect, and all patients successfully stopped bleeding after one session of sclerotherapy. In terms of safety, the incidence of severe postoperative complications in this group was 0%, which is much lower than the 6.3% incidence of bleeding complications after hemorrhoidectomy in Nelson et al.'s antithrombotic treatment patients[12] and is consistent with the study by Salgueiro et al. in the literature review[19]. They reported that only one patient experienced serious postoperative complications (bleeding requiring blood transfusion) and demonstrated that the effects of polydocanol foam on hemorrhoids with and without bleeding diseases are equivalent. In terms of efficacy, the overall efficacy rate and satisfaction rate of our group of patients 4 weeks after surgery reached 100%, which is equivalent to the effective rate of 88.89% -94.52% reported in the literature review. This finding is similar to the results of a single-center prospective study by Fernandes et al., who analyzed the efficacy in 2000 hemorrhoid patients (including 210 who also received antithrombotic therapy) and reported that 98% of patients were satisfied with bleeding control and prolapse reduction at 4 weeks after surgery [6]. In terms of the postoperative recurrence rate, we reported a recurrence rate of 0% at 4 weeks after surgery, and only 1 patient experienced recurrence at the 1-year follow-up. The overall recurrence rate was 14.29% (1/7), which is not only lower than the 16.67% recurrence rate reported by Gartell et al. in a randomized controlled study of rubber band ligation for mixed hemorrhoids but also lower than the 17.81% recurrence rate reported by Salgueiro et al. in a literature review[19].

Although our research suggests that IST is a safe and effective option for patients with mixed hemorrhoid bleeding who are receiving antithrombotic therapy, it also has several limitations. First, this study is retrospective and has a small sample size. Although we summarized and compared existing relevant research results through a literature review, the number of studies included in the literature review was relatively small, and the number of cases was not sufficient. Second, the outcome indicators, such as efficacy and complications, in this study mainly rely on patients' subjective feelings, without further evaluation through objective indicators or scale scores. Additionally, owing to the small sample size, we did not analyze the differences in the efficacy of different antithrombotic drugs combined with hemorrhoid bleeding for sclerotherapy separately. Finally, although all the patients included in our study were treated with antithrombotic drugs, the preoperative coagulation function of these patients was basically normal, and the international normalized ratio (INR) was within the normal range; thus, further clarification of the efficacy of polydocanol foam for patients with mixed hemorrhoid bleeding combined with abnormal coagulation function was impossible. Therefore, larger prospective studies are needed in the future to clarify these findings further.

Our research revealed that the use of polydocanol foam for IST is a safe and effective method for patients receiving antithrombotic therapy combined with mixed hemorrhoid bleeding. However, larger prospective studies are needed before this is the preferred treatment for such patients.

IST

Injection sclerotherapy

RBL

Rubber band ligation

INR

International normalized ratio.

Ethics approval and consent to participate

This study was approved by the Ethics Committee of Yangpu Hospital of Tongji University (Yangpu District Central Hospital) (No. LL-2024--LW-015) and followed the precepts established by the Helsinki Declaration. The participants provided written informed consent to participate in this study. Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article.

Consent for publication

All authors agreed to publish this manuscript.

Availability of data and materials

The data that support the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author upon reasonable request. Data are located in controlled access data storage at Yangpu Hospital of Tongji University.

Competing interests

The authors declare that they have no competing interests.

Funding

This study was supported by the Clinical Research Special Project of Yangpu District Science and Technology Committee (YPM202303)

Authors’ contributions

Z.L., H.L., W.D., S.W. and H.D. participated in the design of this study.L.L., H.D., and W.D. collected data and performed the statistical analysis. Z.L., H.L., W.D., S.W. and H.D. drafted the manuscript. H.D., H.L., L.L., X.L. reviewed the manuscript. All authors read and approved the fnal manuscript.

Acknowledgements

None.

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Tables 1 to 2 are available in the Supplementary Files section

No competing interests reported.

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Application of polidocanol foam injection sclerotherapy in patients with antithrombotic therapy combined with mixed hemorrhoid bleeding: A single-center experience and literature review

Status:

Version 1

Abstract

Figures

Introduction

Methods

Patients

Surgical methods

Patient Preparation

Preparation of venue and equipment:

Injection therapy steps

Postinjection efficacy evaluation and treatment course

Literature Review

Results

Discussion

Conclusions

Abbreviations

Declarations

References

Tables

Additional Declarations

Supplementary Files

Status:

Version 1