Effect of Anal Lift Exercise on Rehabilitation After Anal Fistula Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Kegel exercises.
- Who it may be relevant to
- Registry conditions: Kegel Exercises. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Anal Lift Exercise on Rehabilitation After Anal Fistula Surgery: a Single-center, Prospective, Open-label, Randomized Clinical Trial
Overview
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.
Detailed description
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.
Interventions
- Procedure Kegel exercises
The patient carried out pelvic floor elevation exercises after the surgery, aiming to accelerate the recovery process and alleviate the pain.
Primary outcome measures
- Record pain score [Time frame: Day 1，2，3，4，5]
- Record the bleeding score. [Time frame: Day 1，2，3，4，5]
- Record the score of anal distension and fullness. [Time frame: Day 1, 2, 3, 4, 5]
Secondary outcome measures (2)
- Compare the defecation situation of the patients. [Time frame: Within 30 days postoperatively]
- Length of hospital stay [Time frame: Daily from Day 1 (max 60 days post-op)]
Eligibility criteria
Inclusion criteria
- Aged between 18 and 55 years old
- Patients diagnosed with anal fistula through digital rectal examination and anoscopy
- Receive operation
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Putian Universoty — Putian
Identifiers
NCT: NCT07250711 · PutianU-007