Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol (EPSITCRYSP)

Endoscopic Treatment of Pilonidal Sinus May Decrease the Recurrence After Crystallized Phenol Application

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.

Study Overview

• Status: Completed
• Conditions: Pilonidal Sinus
• Intervention / Treatment: Procedure: EAPA

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 58 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with pilonidal disease with no acute abscess

Exclusion Criteria:

• Patients with aacute pilonidal disease abscess

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application	Number of Participants without healing of the sinus.	six months
Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application	Recurrence rate	six months

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Study Chair: İbrahim E Gecim, MD, Professor of Surgery, Ankara University Medical School

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: October 2, 2014
• First Submitted That Met QC Criteria: October 26, 2014
• First Posted (Estimate): October 29, 2014

Study Record Updates

• Last Update Posted (Estimate): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 26, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: KRKAP-001