Effect of Anal Lift Exercise on Rehabilitation After Anal Fistula Surgery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kegel Exercises
• Intervention / Treatment: Procedure: Kegel exercises

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.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Putian, Fujian, China, 351100
      • Putian Universoty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observation group; Explain the relevant postoperative precautions and instructions to the patients, and the observation group is allowed to perform random movements.
Experimental: Control group; Explain the relevant postoperative precautions and instructions to the patients, and have the control group perform pelvic floor contraction exercises.	Procedure: Kegel exercises; The patient carried out pelvic floor elevation exercises after the surgery, aiming to accelerate the recovery process and alleviate the pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Record pain score	Assessment timepoints: At postoperative days 1, 2, 3, 4, 5.Pain: 0 points, no pain; 1 point, mild pain, tolerable; 2 points, obvious pain, requiring painkillers; 3 points, severe pain, requiring injection of painkillers.The higher the score, the more severe the anxiety.	Day 1，2，3，4，5
Record the bleeding score.	Assessment timepoints: At postoperative days 1, 2, 3, 4, 5.Bleeding: 0 points, no bleeding; 1 point, a little blood in the stool; 2 points, more blood dripping from the stool, which can be relieved by hemostasis; 3 points, heavy bleeding, requiring suture and ligation for hemostasis.The higher the score, the more severe the anxiety.	Day 1，2，3，4，5
Record the score of anal distension and fullness.	Assessment timepoints: At postoperative days 1, 2, 3, 4, 5.Anal distension: 0 points, none; 1 point, slight distension; 2 points, obvious distension, affecting movement; 3 points, severe distension, unbearable. The higher the score, the more severe the anxiety.	Day 1, 2, 3, 4, 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the defecation situation of the patients.	Patients with anal fistula should start doing pelvic floor exercises and controlling their diet from the day of surgery until the fifth day. Observe the defecation situation.	Within 30 days postoperatively
Length of hospital stay	Record the length of the patient's hospital stay and make a comparison	Daily from Day 1 (max 60 days post-op)

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Putian University

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: anal fistula; Kegel Exercise
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Digestive System Fistula; Fistula; Intestinal Fistula; Pathological Conditions, Signs and Symptoms; Rectal Fistula
• Other Study ID Numbers: PutianU-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No