Clinical trial NCT04722965: Treatment of Lower Transsphincteric Perianal Fistula: Fistulotomy With Marsupialization vs Open Wound
Official title: Randomized Clinical Trial for the Treatment of Lower Transsphincteric Perianal Fistula Using Fistulotomy With Marsupialization vs Open Wound
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Perianal Fistula
Transsphincteric Anal Fistula
Keywords: low transsphincteric anal fistula
fistulotomy
marsupialization
perianal fistula
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Wound healing time
timeFrame: 6 weeks
Secondary outcomes:
measure: Postoperative pain
timeFrame: 6 weeks
measure: Return to daily activities
timeFrame: 6 weeks
measure: Operating time
timeFrame: 60 minutes
measure: Hospitalization time
timeFrame: 2 days
measure: Bleeding of the postoperative wound
timeFrame: 6 weeks
measure: Anal incontinence
timeFrame: 6 weeks
measure: Frequency of dressing change
timeFrame: 6 weeks
measure: Who performs the dressing change
timeFrame: 6 weeks
measure: Postoperative wound infection
timeFrame: 6 weeks
measure: Recurrence of the fistula
timeFrame: 1 year
Other outcomes:
Locations:
city: Sant Pere De Ribes
country: Spain
facility: Consorci Sanitari Alt Penedes i Garraf
state: Barcelona
Study officials:
affiliation: CSAPG
name: Jessica Gonzales, MD
role: PRINCIPAL_INVESTIGATOR
References: