Perianal Fistula, Transsphincteric Anal Fistula
Conditions
Keywords
low transsphincteric anal fistula, fistulotomy, marsupialization, perianal fistula
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.
Interventions
PROCEDUREFistulotomy 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.
PROCEDUREFistulotomy 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.
Sponsors
Consorci Sanitari de l'Alt Penedès i Garraf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Number of bleeding episodes that require more changing of the dressings or assistance of a medical professional. |
| Postoperative pain | 6 weeks | Maximum pain experienced by the patient in the postoperative period measured by the visual scale of pain. |
| 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. |
| 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. |
Countries
Spain
Outcome results
None listed