Back to resultsEndoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol (EPSITCRYSP)
Primary Purpose
Pilonidal Sinus
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
EAPA
Sponsored by
About this trial
This is an interventional treatment trial for Pilonidal Sinus
Eligibility Criteria
Inclusion Criteria:
- Patients with pilonidal disease with no acute abscess
Exclusion Criteria:
- Patients with aacute pilonidal disease abscess
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EAPA for Pilonidal Disease
Arm Description
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.
Outcomes
Primary Outcome Measures
Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application
"Number of Participants with Adverse Events as a Measure of Safety and Tolerability".
Secondary Outcome Measures
Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application
Number of Participants without healing of the sinus.
Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application
Recurrence rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02277340
Brief Title
Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol
Acronym
EPSITCRYSP
Official Title
Endoscopic Treatment of Pilonidal Sinus May Decrease the Recurrence After Crystallized Phenol Application
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EAPA for Pilonidal Disease
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
EAPA
Intervention Description
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 Outcome Measure Information:
Title
Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application
Description
"Number of Participants with Adverse Events as a Measure of Safety and Tolerability".
Time Frame
six months
Secondary Outcome Measure Information:
Title
Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application
Description
Number of Participants without healing of the sinus.
Time Frame
six months
Title
Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application
Description
Recurrence rate
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with pilonidal disease with no acute abscess
Exclusion Criteria:
Patients with aacute pilonidal disease abscess
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İbrahim E Gecim, MD
Organizational Affiliation
Professor of Surgery, Ankara University Medical School
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol
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