NCT07080424

Brief Summary

The study was done at Central Park Medical College Lahore during January to September, 2024. Low fistula-in-ano patients were randomized into 2 groups i.e. Group A (SUR 1 fistulectomy) and Group B (170 patients in each group). The same surgical team applied all their procedures to reach spinal anesthesia. Wound infection determined after the operation was done clinically and verified by culture at 10 days of follow up. Statistical analyses based on SPSS version 26 were carried out and p \< 0.05 terminated as significant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

July 7, 2025

Last Update Submit

July 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of wound healing

    by employing southampton scale for assessment of wound healing scale; assessment of wound healing was done

    6 weeks

Study Arms (2)

Group 1

patients undergoing Fistulectomy with Marsupialization

Procedure: Fistulectomy with Marsupialization

Group 2

patients undergoing Fistulectomy only

Procedure: Fistulectomy

Interventions

Patients with fistula in ano treated with Fistulectomy with Marsupialization and were compared for wound healing with other group

Group 1
FistulectomyPROCEDURE

Patients with fistula in ano treated with Fistulectomy and were compared for wound healing with other group

Group 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of either gender aged between 18-70 years presenting with fistula in-ano

You may qualify if:

  • Patients of either gender aged between 18-70 years presenting with fistula in-ano

You may not qualify if:

  • the patients with recurrent fistula, with anal fissures, chronic colitis and hemorrhoids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Park Teaching Hospital

Lahore, 54600, Pakistan

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
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 23, 2025

Study Start

January 1, 2024

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations