Efficacy and safety of an innovatively modified cutting seton technique for the treatment of high anal fistula

Abstract

Background: Anal fistula is a common anorectal disease. So far, operation is still the optimal method to cure anal fistula. High anal fistula (HAF) is an even more clinically difficult disease to treat. Evidence suggested that seton placement can be a definitive treatment for HAF. However, tightening the seton brings great pain to patients, which affects the clinical application of the therapy. Also, this may lead to difficulty in controlling anal fluids and gas because of the larger scar left and the local defect in the anal after the operation. We propose an innovative seton technique for the treatment of HAF, after long term attempts, the operation of the modified seton cutting technique. The aim of our present study is to compare the difference of anal function, healing time, pain severity, recurrence, and complications between the procedure of the modified seton cutting technique and the conventional cutting seton operation against HAF with a randomized, controlled, prospective study. Methods: 204 participants in this trial will be randomly divided into treatment group (procedure of the modified seton cutting technique) and control group (cutting seton technique) in a 1:1 ratio. The outcomes of continence state, pain severity after tightening, complete healing of fistula, duration to healing, operation time, recurrence rates, and postoperative complications will be recorded at 1, 2, 3, 4 weeks, then every month in the outpatient clinic. Data will be analyzed by SPSS version 22. Conclusions: The findings of the study will help to explore the efficacy and safety of the procedure of the modified seton cutting technique against AF. Trial registration number: DOI 10.17605/OSF.IO/V6G2S

Effectiveness of Partial Fistula Tract Excision with Loose Seton Application to Treat Perianal Fistula

“…Complications such as postoperative recurrence and stool incontinence may improve during the follow-up period (15). The basic principle of surgical treatment is to remove or close the fistula canal before incontinence occurs (17)(18)(19). However, the choice of surgical management is mostly influenced by experience and personal preference.…”

Surgical treatment of anal fistula

“…Установка свободного сетона в ряде случаев приводит к постепенному, медленному пересечению анального сфинктера или к «миграции» лигатуры в дис-SIBERIAN SCIENTIFIC MEDICAL JOURNAL 2023; 43 (5): 74−84 тальном направлении и формированию более поверхностного свища [63]. Применение режущей, пересекающей лигатуры причиняет пациентам сильную боль, что сказывается на клиническом применении данного метода [64]. Проспективное исследование с участием 372 пациентов в Саудовской Аравии, у которых был диагностирован высокий анальный свищ и применено лечение режущим сетоном, показало, что продолжительность симптомов варьировала от 3 до 21 месяца.…”

Simplified dressing change after surgery for high anal fistula: A prospective, single centre randomized controlled study on loose combined cutting seton (LCCS) technique

“…3,4 The application of traditional cutting seton has improved the cure rate of high complex anal fistula and effectively reduced the risk of anal incontinence by cutting the fistula sphincter while causing inflammatory changes and adhesions to form in the same place, thus protecting the anal sphincter from damage as much as possible, but it inevitably brings problems such as obvious pain, larger trauma, longer healing time and slower recovery of anal function. [5][6][7] The loose combined cutting seton (LCCS) technique is a new surgical method for high anal fistula based on the traditional Chinese medicine cutting seton technique, which was developed by Dr. Zheng Lihua after decades of clinical application and improvement. 8 LCCS advocates hanging the silk thread to the highest spot of each fistula and tying it firmly, without tightening the thread during postoperative dressing changes, which can reduce the damage to the anal sphincter and pain during dressing changes while effectively improving the healing rate.…”

“…Without surgery, high anal fistulas are recurrent, with swelling and hardness around the anus, pain, pus flow and itching 3,4 . The application of traditional cutting seton has improved the cure rate of high complex anal fistula and effectively reduced the risk of anal incontinence by cutting the fistula sphincter while causing inflammatory changes and adhesions to form in the same place, thus protecting the anal sphincter from damage as much as possible, but it inevitably brings problems such as obvious pain, larger trauma, longer healing time and slower recovery of anal function 5–7 . The loose combined cutting seton (LCCS) technique is a new surgical method for high anal fistula based on the traditional Chinese medicine cutting seton technique, which was developed by Dr. Zheng Lihua after decades of clinical application and improvement 8 .…”