Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol

Pilonidal Sinus Clinical Trial

— EPSITCRYSP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277340
• Other study ID #: KRKAP-001
• Status: Completed
• Phase: Phase 1
• First received: October 2, 2014
• Last updated: October 26, 2014
• Start date: February 2014
• Est. completion date: May 2014

Study information

• Verified date: October 2014
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with pilonidal disease with no acute abscess

Exclusion Criteria:

• Patients with aacute pilonidal disease abscess

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application	"Number of Participants with Adverse Events as a Measure of Safety and Tolerability".	six months	Yes
Secondary	Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application	Number of Participants without healing of the sinus.	six months	Yes
Secondary	Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application	Recurrence rate	six months	Yes