Wound HealingNCT07080424
Comparison of Wound Healing in Fistulectomy and Fistulectomy With Marsupialization
An observational study of Wound Healing and Fistulectomy, run by Central Park Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Wound Healing, Fistulectomy, Fistulectomy With Marsupialization
- What is being tested?
- Fistulectomy with Marsupialization and Fistulectomy
- Type of treatment
- Surgery or procedure
- How many people
- 340 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 1 Oct 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of either gender aged between 18-70 years presenting with fistula in-ano
Who may be able to join
- Patients of either gender aged between 18-70 years presenting with fistula in-ano
Who cannot join
- the patients with recurrent fistula, with anal fissures, chronic colitis and hemorrhoids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Post-Operative Wound Healing in Fistulectomy and Fistulectomy With Marsupialization in Patients With Low Fistula in Ano
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.
- Being tested
- Fistulectomy with Marsupialization, Fistulectomy
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fistulectomy with MarsupializationProcedure or surgery
Patients with fistula in ano treated with Fistulectomy with Marsupialization and were compared for wound healing with other group
FistulectomyProcedure or surgery
Patients with fistula in ano treated with Fistulectomy and were compared for wound healing with other group
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | patients undergoing Fistulectomy with Marsupialization Receives: Procedure: Fistulectomy with Marsupialization | |
| Group 2 | patients undergoing Fistulectomy only Receives: Procedure: Fistulectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of wound healing
by employing southampton scale for assessment of wound healing scale; assessment of wound healing was done
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Jan 2024
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 340 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Central Park Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirza Zeeshan Sikandar, Central Park Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080424
- Sponsor's protocol ID
- PHRF/2023/S23
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-Operative Wound Healing in Fistulectomy and Fistulectomy With Marsupialization in Patients With Low Fistula in Ano
- ClinicalTrials.gov ID
- NCT07080424
- Acronym / sponsor ID
- PHRF/2023/S23
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Central Park Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Fistulectomy with Marsupializationpatients undergoing Fistulectomy with Marsupialization |
| Group 2 | – | Procedure: Fistulectomypatients undergoing Fistulectomy only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of either gender aged between 18-70 years presenting with fistula in-ano
Key inclusion criteria (1 listed)
- Patients of either gender aged between 18-70 years presenting with fistula in-ano
Key exclusion criteria (1 listed)
- the patients with recurrent fistula, with anal fissures, chronic colitis and hemorrhoids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fistulectomy with MarsupializationPatients with fistula in ano treated with Fistulectomy with Marsupialization and were compared for wound healing with other group | Procedure or surgery | Group 1 |
| FistulectomyPatients with fistula in ano treated with Fistulectomy and were compared for wound healing with other group | Procedure or surgery | Group 2 |
Primary outcome
Assessment of wound healing
Time frame: 6 weeks
by employing southampton scale for assessment of wound healing scale; assessment of wound healing was done
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Healing and Fistulectomy, run by Central Park Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of wound healing (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.