Comparison of Wound Healing in Fistulectomy and Fistulect... | NCT07080424

Studies
Comparison of Wound Healing in Fistulectomy and Fistulectomy With Marsupialization

NCT07080424

Sponsor

Central Park Medical College

Status

Completed

Last Update Posted

Jul 23, 2025Actual

Enrollment

340Actual

Phase

Not provided

Conditions

Wound Healing
Fistulectomy
Fistulectomy With Marsupialization
Fistula in Ano

Interventions

Fistulectomy with Marsupialization
Fistulectomy

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Sep 1, 2024Actual

Completion Date

Oct 1, 2024Actual

First Submitted Date

Jul 7, 2025

First Submission Date that Met QC Criteria

Jul 14, 2025

First Posted Date

Jul 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2025

Last Update Posted Date

Jul 23, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mirza Zeeshan Sikandar, Principal Investigator, Central Park Medical CollegePrincipal Investigator

Lead Sponsor

Central Park Medical CollegeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

340Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		patients undergoing Fistulectomy with Marsupialization	Procedure: Fistulectomy with Marsupialization
Group 2		patients undergoing Fistulectomy only	Procedure: Fistulectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fistulectomy with Marsupialization	Procedure	Patients with fistula in ano treated with Fistulectomy with Marsupialization and were compared for wound healing with other group	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of wound healing	by employing southampton scale for assessment of wound healing scale; assessment of wound healing was done	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Park Teaching Hospital		Lahore		54600	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012003	Rectal Fistula

Ancestor Terms

ID	Term
D007412	Intestinal Fistula
D016154	Digestive System Fistula
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided