Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol

Phase 1

Completed

• Conditions: Pilonidal Sinus
• Interventions: Procedure: EAPA

• Registration Number: NCT02277340
• Lead Sponsor: Ankara University

Brief Summary

This study presents 23 sacrococcygeal pilonidal disease cases treated with endoscopic cleaning and fulguration of pilonidal sinus inner surfaca followed by application of crystallized phenol into the sinus.

Detailed Description

Endoscopic treatment and crytallized phenol application are two sovereign treatments described for pilonidal disease. The curative rate may be as low as 65 % and the recurrence rate is at least 10 % after crystallized phenol alone application for pilonidal disease. The experience with endoscopic treatment of pilonidal sinus is only limited but at least 4 % recurrence rate was reported.

In this study a preliminary group of 23 patients were treated with combination of these two modalities between February to May 2014 and at the end of 6-9 months follow up, there was no recurrence after excellent cosmetic results. Patients were all operated and mild sedation and local anesthesia. There was no serious complication but only some skin irritation was noticed secondary to phenol burn. Some patients felt mild pain and the pain was self limited in most cases where only a few needed oral pain killers. Some patients were observed to have mild drainage from the sinus but only two of them needed further application of phenol crystals.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-10
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-26
• Last Update Submitted: 2014-10-26
• Study First Posted: 2014-10-29
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Patients with pilonidal disease with no acute abscess

Exclusion Criteria

• Patients with aacute pilonidal disease abscess

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EAPA for Pilonidal Disease	EAPA	The abbrevition EAPA is used to describe the study. The cohort of pilonidal disease patients treated who do not have an acute abscess or other problems like hydradenitis suppurativa, has been treated by endoscopy assisted fulguration of the inner surface and additional crystallized phenol application for further clean up of the remaining tissue as well as preventing bacterial growth.

Primary Outcome Measures

Name	Time	Method
Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application	six months	"Number of Participants with Adverse Events as a Measure of Safety and Tolerability".

Secondary Outcome Measures

Name	Time	Method
Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application	six months	Recurrence rate