Pilonidal Disease, Pilonidal Disease of Natal Cleft, Pilonidal Sinus, Sacrococcygeal Fistula
Conditions
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
Interventions
DRUGphenolization
In case of phenolization group, an Abbocath catheter 18 G is introduced into the cystic cavity. Undiluted 88% phenol is instilled into the cavity, ensuring that the cystic cavity is filled. It is maintained for 5 min until complete coagulation of the cyst is achieved.
PROCEDUREConventional surgery
In case of conventional surgery, entire exeresis is performed by means of an electric scalpel
Sponsors
HJ23
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recurrence | up to 1 year | short or medium-term recurrence of sacrococcygeal disease. For this purpose, a clinical follow-up was performed in outpatient clinics where the patient was assessed and explored regularly for signs of recurrence. The number of recurrences per group and the time from surgery to recurrence were assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sick leave | up to 1 year | time from surgery to return to work. This will be counted in days. |
Countries
Spain
Outcome results
None listed