NCT05404243

Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease

Randomized Clinical Trial to Test the Efficacy and Safety of Phenolization in Uncomplicated Sacrococcygeal Pilonidal Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: HJ23 · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Sacrococcygeal Fistula
• Pilonidal Sinus
• Pilonidal Disease
• Pilonidal Disease of Natal Cleft

Interventions

Type	Name	Description
DRUG	phenolization	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.
PROCEDURE	Conventional surgery	In case of conventional surgery, entire exeresis is performed by means of an electric scalpel

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-12-01
• Completion: 2022-05-01
• First posted: 2022-06-03
• Last updated: 2022-06-07

Locations

1 site across 1 country: Spain