Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol (EPSITCRYSP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02277340|
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : October 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pilonidal Sinus||Procedure: EAPA||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Treatment of Pilonidal Sinus May Decrease the Recurrence After Crystallized Phenol Application|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
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.
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.
- 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".
- Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application [ Time Frame: six months ]Number of Participants without healing of the sinus.
- Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application [ Time Frame: six months ]Recurrence rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277340
|Study Chair:||İbrahim E Gecim, MD||Professor of Surgery, Ankara University Medical School|