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Not yet recruitingNCT07250711Updated Apr 17, 2026

Effect of Anal Lift Exercise on Rehabilitation After Anal Fistula Surgery

An interventional study of Kegel exercises in Kegel Exercises, sponsored by The Affiliated Hospital of Putian University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by The Affiliated Hospital of Putian University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Kegel Exercises

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Keywords

  • anal fistula
  • Kegel Exercise
03

In context

Rectal Fistula

189 studies on the registry are indexed under Rectal Fistula; 42 are open to participants now.

This study's planned enrollment of 124 is above the median of 68 across 130 interventional studies indexed under Rectal Fistula.

Browse Rectal Fistula studies →

Lead sponsor

The Affiliated Hospital of Putian University is the lead sponsor of 14 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
124 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureKegel exercises

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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes

  1. 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.

    Time frame: Within 30 days postoperatively

  2. Length of hospital stay

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

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

07

Study locations

1 site
  • Putian Universoty
    Putian, Fujian 351100, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07250711
Lead sponsor
The Affiliated Hospital of Putian University
Responsible party
Sponsor
First posted
Nov 26, 2025
Start date
Jun 20, 2026 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Apr 17, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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