Clinical trial NCT05404243: Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease
Official title: Randomized Clinical Trial to Test the Efficacy and Safety of Phenolization in Uncomplicated Sacrococcygeal Pilonidal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sacrococcygeal Fistula
Pilonidal Sinus
Pilonidal Disease
Pilonidal Disease of Natal Cleft
Lead sponsor: HJ23
Sponsor class: INDUSTRY
First posted: 2022-06-03
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical trial
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial to test the efficacy and safety of phenolization in uncomplicated Sacrococcygeal pilonidal disease

Detailed description: This is a single center randomized controlled clinical trial consisting in 2 treatment groups.

All patients admitted at University Hospital of Tarragona Joan XXIII with Sacrococcygeal pilonidal disease were likely to enter in the study. All patients with uncomplicated sacrococcygeal disease, localized in the midline and with only 1 fistulous orifice.

When the patients met the criteria and after consenting the admission in the study, they were included and were operated. The patients were randomly assigned to the phenolization group or conventional-surgery group. A unique anesthetic and surgical protocol were established for both groups.

Patients in the phenolization group underwent curettage with an otorhinolaryngology spatula and endocavitary phenol with an abocath needle until complete coagulation of the cyst. Patients in the conventional-surgery group were referred to conventional surgery consisting of complete excision of the cyst and closure by second intention. Both groups were managed without admission and discharged within a few hours if they met ALDRETE criteria. They were followed daily by the home hospitalization team

The main endpoint was short or medium-term recurrence of sacrococcygeal disease. The number of recurrences per group and the time from surgery to recurrence were assessed. Secondary endpoints included degree of satisfaction and sick leave

Eligibility criteria: Inclusion Criteria:

* patients over 18 years old
* ASA (american society anesthesiologists) less than or equal to 3
* patients who live accompanied in a home at a maximum distance of 30 minutes from the hospital
* adequate cognitive capacity

Exclusion Criteria:

* pregnancy or breastfeeding
* complicated Sacrococcygeal pilonidal disease
* non-randomized surgical management

Primary outcomes:
measure: recurrence
timeFrame: up to 1 year
Secondary outcomes:
measure: sick leave
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Tarragona
country: Spain
facility: Jordi Elvira Lopez
Study officials:
References:
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