NCT02116738

Brief Summary

The investigators want to share our study that is the "Comparison of Modified Limberg Flap Transposition and Lateral Advancement Flap Transposition with Burrow's Triangle in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

2 months

First QC Date

April 14, 2014

Last Update Submit

April 15, 2014

Conditions

Sacrococcygeal Pilonidal Disease

Keywords

flappilonidal sinusvasrecurrence

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants with a 95% Decrease in Pain Visual Analogue Scale (VAS)

    12 hours

Study Arms (1)

Flap Transposition Technique

EXPERIMENTAL

Flap Transposition Technique

Procedure: Flap Transposition Procedures

Interventions

Flap Transposition ProceduresPROCEDURE

Modified Limberg Flap Transposition Procedure and Lateral Advancement Flap Transposition with Burrow's Triangle Procedure in The treatment of Pilonidal Sinus Diseases

Flap Transposition Technique

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Pilonidal Sinus Disease
  • Must be able to suitable for the surgery

You may not qualify if:

  • Patients with Recurrent Pilonidal Sinus disease
  • Patient whom is not suitable for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Mevki Military Hospital : General Surgery Department

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (1)

  • Yuksel BC, Berkem H, Ozel H, Hengirmen S. A new surgical method of pilonidal sinus treatment: a bilaterally paralel elliptic fascio-cutaneous advancement flap technique. Bratisl Lek Listy. 2012;113(12):728-31. doi: 10.4149/bll_2012_165.

    PMID: 23173633BACKGROUND

Related Links

MeSH Terms

Conditions

Pilonidal SinusRecurrence

Condition Hierarchy (Ancestors)

CystsNeoplasmsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. MEHMET SAYDAM (GENERAL SURGEON)

Study Record Dates

First Submitted

April 14, 2014

First Posted

April 17, 2014

Study Start

June 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

TU(1)