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Completed

NCT Number: NCT02277340

Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol

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.

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Key information

Conditions

Pilonidal Sinus Cysts Neoplasms

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with pilonidal disease with no acute abscess

Exclusion criteria

  • Patients with aacute pilonidal disease abscess

Treatment and study plan

EAPA

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.

Primary outcomes

  1. Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application

    Time frame: six months

    "Number of Participants with Adverse Events as a Measure of Safety and Tolerability".

Secondary outcomes

  1. Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application

    Time frame: six months

    Number of Participants without healing of the sinus.

  2. Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application

    Time frame: six months

    Recurrence rate

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Acronym: EPSITCRYSP

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 29, 2014
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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