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

Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf (Other)

Overall Status

Recruiting

CT.gov ID

NCT04722965

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Perianal Fistula Transsphincteric Anal Fistula	Procedure: Fistulotomy with marsupialization Procedure: Fistulotomy with open wound	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fistulotomy with marsupialization 40 patients with a simple low transsphincteric anal fistula. A fistulotomy with marsupialization is performed.	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.
Active Comparator: Fistulotomy with open wound 40 patients with a simple low transsphincteric anal fistula. A fistulotomy leaving the wound open is performed.	Procedure: 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.

Arm

Intervention/Treatment

Active Comparator: Fistulotomy with marsupialization

40 patients with a simple low transsphincteric anal fistula. A fistulotomy with marsupialization is performed.

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.

Active Comparator: Fistulotomy with open wound

40 patients with a simple low transsphincteric anal fistula. A fistulotomy leaving the wound open is performed.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Wound healing time [6 weeks]
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.

Secondary Outcome Measures

Postoperative pain [6 weeks]
Maximum pain experienced by the patient in the postoperative period measured by the visual scale of pain.
Return to daily activities [6 weeks]
Days it takes the patients to return their daily activities (e.g. job).
Operating time [60 minutes]
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.
Hospitalization time [2 days]
Days the patient has to stay admitted in the hospital.
Bleeding of the postoperative wound [6 weeks]
Incidence of bleeding episodes that require more changing of the dressings or assistance of a medical professional.
Anal incontinence [6 weeks]
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.
Frequency of dressing change [6 weeks]
Number of times per day a patient needs a dressing change
Who performs the dressing change [6 weeks]
Indicate who performs the dressing change: Patient, family member or medical professional.
Postoperative wound infection [6 weeks]
Presence of erythema, induration surrounding the wound or suppuration with or without an isolated pathogenic microorganism.
Recurrence of the fistula [1 year]
Reappearance of the fistula after complete healing of the surgical wound within the period of the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.