Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol

NCT ID: NCT02277340

Last Updated: 2014-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-05-31

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.

Conditions

Pilonidal Sinus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EAPA for Pilonidal Disease

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.

Group Type: EXPERIMENTAL

EAPA

Intervention Type: PROCEDURE

Under sedation and local anesthesia, a pit of pilonidal disease is widened, hair and debris removed and cavity first ablated by endoscopy assisted diathermy the filled with crystallized phenol. The remaining pits were also fulgurated.

Interventions

EAPA

Under sedation and local anesthesia, a pit of pilonidal disease is widened, hair and debris removed and cavity first ablated by endoscopy assisted diathermy the filled with crystallized phenol. The remaining pits were also fulgurated.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with pilonidal disease with no acute abscess

Exclusion Criteria

• Patients with aacute pilonidal disease abscess

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

I Ethem Gecim

Prof Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İbrahim E Gecim, MD

Role: STUDY_CHAIR

Professor of Surgery, Ankara University Medical School

Other Identifiers

KRKAP-001

Identifier Type: -

Identifier Source: org_study_id