This study will compare the results of marsupialization versus open wound after fistulotomy in low transsphincteric perianal fistulas.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
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.
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.
Consorci Sanitari Alt Penedes i Garraf
Sant Pere de Ribes, Barcelona, Spain
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.
Time frame: 6 weeks
Postoperative pain
Maximum pain experienced by the patient in the postoperative period measured by the visual scale of pain.
Time frame: 6 weeks
Return to daily activities
Days it takes the patients to return their daily activities (e.g. job).
Time frame: 6 weeks
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.
Time frame: 60 minutes
Hospitalization time
Days the patient has to stay admitted in the hospital.
Time frame: 2 days
Bleeding of the postoperative wound
Number of bleeding episodes that require more changing of the dressings or assistance of a medical professional.
Time frame: 6 weeks
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.
Time frame: 6 weeks
Frequency of dressing change
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Number of times per day a patient needs a dressing change
Time frame: 6 weeks
Who performs the dressing change
Indicate who performs the dressing change: Patient, family member or medical professional.
Time frame: 6 weeks
Postoperative wound infection
Presence of erythema, induration surrounding the wound or suppuration with or without an isolated pathogenic microorganism.
Time frame: 6 weeks
Recurrence of the fistula
Reappearance of the fistula after complete healing of the surgical wound within the period of the study.
Time frame: 1 year