Effect of Anal Lift Exercise on Rehabilitation After Anal Fistula Surgery

Официальное название

Effect of Anal Lift Exercise on Rehabilitation After Anal Fistula Surgery: a Single-center, Prospective, Open-label, Randomized Clinical Trial

Обзор

This prospective randomized controlled study aims to include patients who have undergone anal fistula surgery, to observe the impact of early postoperative pelvic floor muscle training combined with dietary intervention on postoperative pain, bleeding, anal distension and defecation function, with the goal of clarifying the value of early rehabilitation intervention in the recovery after anal fistula surgery, and providing a reference for optimizing postoperative management plans in clinical practice.

Подробное описание

This study is a single-center prospective randomized controlled clinical trial, which plans to include 124 patients aged 18 to 75 years who are scheduled to undergo anal fistula surgery. They will be randomly assigned in a 1:1 ratio to the observation group and the control group. The control group will receive the conventional postoperative management plan, including dressing changes, anti-infection treatment, pain relief, and basic dietary guidance. The observation group, on the other hand, will, in addition to the above, undergo standardized pelvic floor muscle training and postoperative dietary control intervention from the day of surgery to the fifth postoperative day. The pain score, bleeding score, and anal distension and fullness score of the patients in both groups will be continuously collected on the first, second, third, fourth, and fifth postoperative days. At the same time, the related indicators of defecation will be observed and recorded. The aim is to systematically evaluate the clinical effect of early postoperative pelvic floor muscle training combined with dietary management on pain relief, bleeding control, improvement of anal distension and fullness, and recovery of defecation function in patients after anal fistula surgery, providing high-quality evidence-based basis for formulating more optimized and targeted early rehabilitation management plans after anal fistula surgery.

Вмешательства

• Процедура Kegel exercises
  The patient carried out pelvic floor elevation exercises after the surgery, aiming to accelerate the recovery process and alleviate the pain.

Первичные конечные точки

• Record pain score [Срок оценки: Day 1，2，3，4，5]
• Record the bleeding score. [Срок оценки: Day 1，2，3，4，5]
• Record the score of anal distension and fullness. [Срок оценки: Day 1, 2, 3, 4, 5]

Вторичные конечные точки (2)

• Compare the defecation situation of the patients. [Срок оценки: Within 30 days postoperatively]
• Length of hospital stay [Срок оценки: Daily from Day 1 (max 60 days post-op)]

Критерии участия

Критерии включения

• Aged between 18 and 55 years old
• Patients diagnosed with anal fistula through digital rectal examination and anoscopy
• Receive operation

Критерии исключения

• The patient has a mental disorder.
• Patients with hemorrhoids
• Anal fistula combined with perianal abscess
• Patients who are unable to cooperate with follow-up visits

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Putian Universoty — Putian

Идентификаторы

NCT: NCT07250711 · PutianU-007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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