Effect of Anal Lift Exercise on Rehabilitation After Anal Fistula Surgery

April 14, 2026 updated by: The Affiliated Hospital of Putian University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1，2，3，4，5
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.
Day 1，2，3，4，5
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.
Day 1, 2, 3, 4, 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Within 30 days postoperatively
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
Daily from Day 1 (max 60 days post-op)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Hospital of Putian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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