Treatment of Lower Transsphincteric Perianal Fistula: Fistulotomy With Marsupialization vs Open Wound

Perianal Fistula Clinical Trial

Official title:

Randomized Clinical Trial for the Treatment of Lower Transsphincteric Perianal Fistula Using Fistulotomy With Marsupialization vs Open Wound

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04722965
• Other study ID #: CSAPG-13
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2024
• Source: Consorci Sanitari de l'Alt Penedès i Garraf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the results of marsupialization versus open wound after fistulotomy in low transsphincteric perianal fistulas.

Description:

This is a multi-center triple blinded randomized clinical trial in which we'll compare two techniques for the treatment of simple low transsphincteric perianal fistulas. 40 patients will undergo a fistulotomy with marsupialization and 40 patients will undergo a fistulotomy with open wound. There will be an inclussion visit in which personal information will be recorded and the consent will be signed. Randomization will be done after inclusion, following a balanced blocks model. Information of the surgery technic won't be available for the investigator. The patients will have a journal in which they'll write their postoperative symptoms. Follow up will be done at weeks 2, 4 and 6 by the main investigator of each center. Data will be based in clinical examination, patient's diary and medical records. Statistical analysis of the primary outcome will be based in a superiority analysis using the Mantel-Cox test, or in case needed, a multivariate Cox regression analysis. The secondary outcomes will be analyzed by comparing times, percentages, mean or median with parametric or non parametric tests as it corresponds.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Low transsphinteric perianal fistula, defined as a single tract in the lower third of the anal sphincter, confirmed by ultrasound and intraoperative evaluation.
• Ability to understand the study, to sign the consent and to complete the follow-up.

Exclusion Criteria:

• Under 18 years of age.
• Complex/recurrent fistula.
• Patients in which by clinical criteria is decided not to perform a fistulotomy.
• Anorectal malignancy.
• Crohn's desease.
• ASA IV or other contraindication for surgery.
• Inmunosuppressed patients or in treatment with steroids or cytotoxic drugs.

Related Conditions & MeSH terms

• Fistula
• Perianal Fistula
• Rectal Fistula
• Transsphincteric Anal Fistula

Intervention

Procedure:
• Fistulotomy with marsupialization
A probe is placed in the fistula tract and it's laid open over that probe. The tract is curretted. Wound edges are sutured to the bottom of the fistula using interrupted sutures of vicryl 3-0 completing the marsupialization.
• Fistulotomy with open wound
A probe is placed in the fistula tract and it's laid open over that probe. The tract is curretted. The wound is left open.

Locations

Country	Name	City	State
Spain	Consorci Sanitari Alt Penedes i Garraf	Sant Pere De Ribes	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing time	Comparisson of the time it takes for the wound to not have areas without epithelium after the fistulotomy between the group with marsupialization and the open wound group.	6 weeks
Secondary	Postoperative pain	Maximum pain experienced by the patient in the postoperative period measured by the visual scale of pain.	6 weeks
Secondary	Return to daily activities	Days it takes the patients to return their daily activities (e.g. job).	6 weeks
Secondary	Operating time	Time the surgery takes since the assessment of the fistula tract to the beginning of dressing of the postoperative wound. It's measured in minutes.	60 minutes
Secondary	Hospitalization time	Days the patient has to stay admitted in the hospital.	2 days
Secondary	Bleeding of the postoperative wound	Number of bleeding episodes that require more changing of the dressings or assistance of a medical professional.	6 weeks
Secondary	Anal incontinence	Postoperative anal incontinence measured by the Browning and Parks incontinence scale: I: normal continence, II: Continent for solid and liquid stools but not for flatus, III: Continent for solid stools only, IV: Complete incontinence.	6 weeks
Secondary	Frequency of dressing change	Number of times per day a patient needs a dressing change	6 weeks
Secondary	Who performs the dressing change	Indicate who performs the dressing change: Patient, family member or medical professional.	6 weeks
Secondary	Postoperative wound infection	Presence of erythema, induration surrounding the wound or suppuration with or without an isolated pathogenic microorganism.	6 weeks
Secondary	Recurrence of the fistula	Reappearance of the fistula after complete healing of the surgical wound within the period of the study.	1 year