NCT07250711

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

June 20, 2026

Expected
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

10 days

First QC Date

September 18, 2025

Last Update Submit

April 14, 2026

Conditions

Keywords

anal fistulaKegel Exercise

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Compare the defecation situation of the patients.

    Within 30 days postoperatively

  • Length of hospital stay

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

Study Arms (2)

Observation group

NO INTERVENTION

Explain the relevant postoperative precautions and instructions to the patients, and the observation group is allowed to perform random movements.

Control group

EXPERIMENTAL

Explain the relevant postoperative precautions and instructions to the patients, and have the control group perform pelvic floor contraction exercises.

Procedure: Kegel exercises

Interventions

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

Control group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Putian Universoty

Putian, Fujian, 351100, China

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2025

First Posted

November 26, 2025

Study Start (Estimated)

June 20, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations