Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease (SPQF)

HJ23

Status and phase: Completed; Phase 4

Conditions: Pilonidal Disease; Sacrococcygeal Fistula; Pilonidal Sinus; Pilonidal Disease of Natal Cleft

Treatments: Drug: phenolization; Procedure: Conventional surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT05404243

HJ23

Details and patient eligibility

About

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

Full 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

Enrollment: 122 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

phenolization group

Experimental group

Description:

Curettage of the sacral cyst is performed using a disposable otorhinolaryngologists curette. The perimeter of the cyst is covered with petroleum jelly to protect the skin, and 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.

Treatment:

Drug: phenolization

conventional surgery

Active Comparator group

Description:

entire exeresis is performed by means of an electric scalpel

Treatment:

Procedure: Conventional surgery