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Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol (EPSITCRYSP)

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ClinicalTrials.gov Identifier: NCT02277340
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
I Ethem Gecim, Ankara University

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.

Condition or disease Intervention/treatment Phase
Pilonidal Sinus Procedure: EAPA Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Phenol

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with pilonidal disease with no acute abscess

Exclusion Criteria:

  • Patients with aacute pilonidal disease abscess

Information from the National Library of Medicine

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


Sponsors and Collaborators
Ankara University
Investigators
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Study Chair: İbrahim E Gecim, MD Professor of Surgery, Ankara University Medical School

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Responsible Party: I Ethem Gecim, Prof Dr, Ankara University
ClinicalTrials.gov Identifier: NCT02277340     History of Changes
Other Study ID Numbers: KRKAP-001
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Pilonidal Sinus
Cysts
Neoplasms
Phenol
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Sclerosing Solutions
Pharmaceutical Solutions