Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02186964
Other study ID # PS42
Secondary ID
Status Completed
Phase N/A
First received July 8, 2014
Last updated July 9, 2014
Start date February 2011
Est. completion date May 2014

Study information

Verified date July 2014
Source Konya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Konya Training and Research Hospital
Study type Interventional

Clinical Trial Summary

Pilonidal sinus is a chronic inflammatory disorder of intergluteal sulcus. The disease seen in between 15-35 years of age and 3-4 times more in males. The incidence of the disease is found as 8.8% in Turkish soldiers. The disorder mainly affects the quality of life.

There are numerous methods in surgical treatment of Pilonidal sinus. The main difference in between those methods is the closing of the defect that occurs after the excision of the sinus tract. The defect can be closed by primary sutures or it can be left for secondary healing. Nowadays, the recurrence rate of flap procedures are lower therefore, flap procedures are commonly used. However, it has been reported that there is no difference between flap procedures and tension free primary closure. This result triggered the controversy that; if the healing side is tension free, midline suturing may have no importance. The aim of this study is to compare the results of 3 different surgical procedures used in treatment of pilonidal disease.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date May 2014
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- having pilonidal sinus disease

- desire for surgical treatment

- accept to be involved in the study

Exclusion Criteria:

- patients under age of 18

- recurrent cases

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
tension free primary closure
tension free primary closure of the defects created by excision of the pilonidal sinus
karydakis
the defect after excision of the pilonidal sinus is closed by Karydakis procedure
Limberg flap
defect after excision of the pilonidal sinus is closed by Limberg flap procedure

Locations

Country Name City State
Turkey Konya Training and Research Hospital Konya

Sponsors (1)

Lead Sponsor Collaborator
Konya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary recurrence recurrence rates two years after the surgery 2 years No
See also
  Status Clinical Trial Phase
Completed NCT03545659 - Childhood Acute Lymphoblastic Leukaemia: Follow-Up
Completed NCT04838613 - Study of Diagnostic Performance of [18F]CTT1057 in BCR Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Recruiting NCT04539665 - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease. N/A
Recruiting NCT04266600 - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease N/A
Terminated NCT03257722 - Pembrolizumab + Idelalisib for Lung Cancer Study Phase 1/Phase 2
Completed NCT01141335 - Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair Phase 4
Completed NCT00029185 - Study of Dehydrex in Patients With Corneal Erosion N/A
Completed NCT01351974 - Sentinel Node Biopsy in Breast Cancer Patients N/A
Not yet recruiting NCT06038422 - GTP Regimen in the Treatment of Refractory/Recurrent HLH Phase 3
Withdrawn NCT03162120 - Comparison of Effectiveness of Ranolazine Plus Metoprolol Combination vs. FlecainidE pluS Metoprolol Combination in ATrial Fibrillation Recurrences FOllowing PhaRmacological or Electrical CardioverSion of AtRial Fibrillation Phase 2/Phase 3
Recruiting NCT04159051 - Charité HT-Prostate N/A
Recruiting NCT02566928 - Patient-Centered Comparative Effectiveness Research (CER) Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence Phase 4
Completed NCT01989845 - Rivaroxaban for the Prevention of Venous Thromboembolism in Asian Patients With Cancer Phase 4
Recruiting NCT01229475 - Stepwise Approach Versus Linear Ablation in Patients With Recurrence of Persistent Atrial Fibrillation N/A
Completed NCT00944554 - Relapse Prevention With Varenicline Phase 4
Terminated NCT02247258 - Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence. Phase 2
Completed NCT03654209 - Post-resection Treatment of Large Colon Polyps N/A
Recruiting NCT05557474 - Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit
Active, not recruiting NCT03865537 - Cold Snare Endoscopic Mucosal Resection Trial N/A