NCT02277340

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

3 months

First QC Date

October 2, 2014

Last Update Submit

October 26, 2014

Conditions

Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

  • Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application

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

    six months

Secondary Outcomes (2)

  • Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application

    six months

  • Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application

    six months

Study Arms (1)

EAPA for Pilonidal Disease

EXPERIMENTAL

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

Interventions

EAPAPROCEDURE

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.

EAPA for Pilonidal Disease

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with pilonidal disease with no acute abscess

You may not qualify if:

  • Patients with aacute pilonidal disease abscess

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

  • İbrahim E Gecim, MD

    Professor of Surgery, Ankara University Medical School

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 29, 2014

Study Start

February 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 29, 2014

Record last verified: 2014-10