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IRCT20141218020364N8 IRCT 2018-03-03 Mazandaran University of Medical Sciences Limberg Flap and Karydakis Flap Surgery For Pilonidal Sinus Disease Comparison of Limberg Flap and Karydakis Flap Surgery in Pilonidal Sinus Disease 2016-10-22 anticipated 80 Complete https://irct.ir/trial/29482 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random drawing of sealed envelopes (Computer-based table of randomization ), Blinding description: The study participants had known two types of common pilonidal off-midline flap surgery treatment, But due to the dressing on the wound, they were not aware of the type of treatment we were used for them. The observer who completed the questionnaire did know the study groups. The original researcher (surgeon) was aware of the study groups. The data analyzer was not known from the study groups. The safety committee and data monitoring were aware of the study groups. N/A Pilonidal Sinus Disease. Intervention 1: First Intervention group: The Limberg flap (LF) group, Rhomboid excision was performed, the lower end being 2 cm lateral to the midline and covering the whole area where the sinus spread. Using electrocautery, hemostasis was provided. In order to ensure tension-free repair, the flap was released at the bottom including gluteal fascia and then slid to medial in order to cover the defect. A suction drain was applied to the region in all patients. The subcutaneous tissue was closed with 2-fold 2/0 polyglactin suture (Ethicon US, LLC, Cincinnati, Ohio), and the skin was closed with 3/0 polypropylene (Ethicon US, LLC) mattress suture. When the drain amount fell below 40 mL/d, it was removed. Intervention 2: Second Intervention group: The Karydakis Flap (LF) group, In this group an asymmetrical elliptic excision was done, lower and upper ends being located at approximately 2 cm lateral to the natal cleft, and all defective tissues were removed until reaching to the healthy borders. After that, the medical wound edge was mobilized, and the flap was slid by suturing to the fascia and skin suitable wound layers on the lateral wound edge corresponding to one another. The subcutaneous tissue was closed with 2-fold 2/0 polyglactin suture, and the skin was closed with 3/0 polypropylene mattress suture. In all patients, a suction drain was applied to the region. When the drain amount fell below 40 mL/d, it was removed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mohhammad Yasin Karami
Faghighi Hospital
Shiraz Iran (Islamic Republic of) 987441756965 +98 71 3839 1385 karamiy@sums.ac.ir Shiraz University of Medical Sciences scientific Mohhammad Yasin Karami
Faghighi Hospital
Shiraz Iran (Islamic Republic of) 7441756965 +98 71 3233 0724 karamiy@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Intergluteal Pilonidal Disease Age more than 15 year Age less than 65 year 15 years 65 years Both Elderly patients with co-morbidity diseases Scars from previous pilonidal surgery Abscess presentation Patients with diabetes mellitus, immunodeficiency, neurological disorder Drug addiction Alcoholism American Society of Anesthesiologists physical status classification 3–4 Those who are under 15 and over 65 Those whose pilonidal sinus orifice was located away more than 3 cm L05.9 Pilonidal cyst and sinus without abscess Treatment - Surgery Treatment - Surgery First Intervention group: The Limberg flap (LF) group, Rhomboid excision was performed, the lower end being 2 cm lateral to the midline and covering the whole area where the sinus spread. Using electrocautery, hemostasis was provided. In order to ensure tension-free repair, the flap was released at the bottom including gluteal fascia and then slid to medial in order to cover the defect. A suction drain was applied to the region in all patients. The subcutaneous tissue was closed with 2-fold 2/0 polyglactin suture (Ethicon US, LLC, Cincinnati, Ohio), and the skin was closed with 3/0 polypropylene (Ethicon US, LLC) mattress suture. When the drain amount fell below 40 mL/d, it was removed. Second Intervention group: The Karydakis Flap (LF) group, In this group an asymmetrical elliptic excision was done, lower and upper ends being located at approximately 2 cm lateral to the natal cleft, and all defective tissues were removed until reaching to the healthy borders. After that, the medical wound edge was mobilized, and the flap was slid by suturing to the fascia and skin suitable wound layers on the lateral wound edge corresponding to one another. The subcutaneous tissue was closed with 2-fold 2/0 polyglactin suture, and the skin was closed with 3/0 polypropylene mattress suture. In all patients, a suction drain was applied to the region. When the drain amount fell below 40 mL/d, it was removed. Pain. Timepoint: Patients were visited weekly for the first month and subsequently every 3 months for the first 6 months. Method of measurement: Visual Analogue Score. Duration of Surgery. Timepoint: During operation. Method of measurement: Evaluated by Surgeon. Satisfaction. Timepoint: Patients were visited weekly for the first month and subsequently every 3 months for the first 6 months. Method of measurement: Visual Analogue Score. Complication. Timepoint: Patients were visited weekly for the first month and subsequently every 3 months for the first 6 months. Method of measurement: Direct supervision by the surgeon. Recurrence Rate. Timepoint: Patients were visited weekly for the first month and subsequently every 3 months for the first 6 months. Method of measurement: Follow up by surgeon. Mazandaran University of Medical Sciences Approved 2016-10-19 Ethics committee of Mazandaran University of Medical Sciences Valie Asr highway Sari Mazandaran Iran (Islamic Republic of)