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NCT Number: NCT07250711

Effect of Anal Lift Exercise on Rehabilitation After Anal Fistula Surgery

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.

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Key information

Conditions

Kegel Exercises Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Putian Universoty

Putian, Fujian, 351100, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kegel exercises

Procedure

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

Primary outcomes

  1. Record pain score

    Time frame: Day 1，2，3，4，5

    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.

  2. Record the bleeding score.

    Time frame: Day 1，2，3，4，5

    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.

  3. Record the score of anal distension and fullness.

    Time frame: Day 1, 2, 3, 4, 5

    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.

Secondary outcomes

  1. Compare the defecation situation of the patients.

    Time frame: Within 30 days postoperatively

    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.

  2. Length of hospital stay

    Time frame: Daily from Day 1 (max 60 days post-op)

    Record the length of the patient's hospital stay and make a comparison

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Putian University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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