Combined Open and Closed Approach for Management of Pilonidal Sinus by Special U-shaped Sutures Without Drain.

NCT04017260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2019-07-12

No results posted yet for this study

Summary

Introduction: Pilonidal sinus disease (PSD) is a common surgical disease frequently seen in the intergluteal cleft. The treatment of this problem is mainly surgical.

Aim: introduce a novel technique of combined open and closed approach for management of primary pilonidal sinus (non-recurrent) by special U-shaped sutures and compare it with other techniques as regard operative time, time of complete wound healing, postoperative pain , time to stop analgesic drugs and evaluate the result of surgery without drain.

Patients: this study was conducted on 160 patients with PSD in the sacrococcygeal region who underwent operation between December 2015 and December 2017. All cases are divided randomly into four groups each consists of 40 patients.

Conditions

  • Pilonidal Sinus

Interventions

PROCEDURE

open and closed approach

The patients were hospitalized, and the site of the operation was shaved on the day of the surgery. All Patients were operated on under spinal anesthesia. Antibiotic was administered to all patients as prophylaxis 60 minutes prior to the surgery. An adhesive tape was used to part the buttocks. The patients were placed in the jack-knife position. (Fig. 1). Methylene blue was injected without pressure through the external opening to delineate the sinus. The operation site was cleaned with 10% povidone-iodine. All sinus tracts were resected en bloc via elliptical incision down to presacral fascia with meticulous hemostasis. Group A:The wound was closed with 0 polypropylene u-shaped sutures .

PROCEDURE

Rhomboid flap technique

The patients were hospitalized, and the site of the operation was shaved on the day of the surgery. All Patients were operated on under spinal anesthesia. Antibiotic was administered to all patients as prophylaxis 60 minutes prior to the surgery. An adhesive tape was used to part the buttocks. The patients were placed in the jack-knife position. (Fig. 1). Methylene blue was injected without pressure through the external opening to delineate the sinus. The operation site was cleaned with 10% povidone-iodine. All sinus tracts were resected en bloc via elliptical incision down to presacral fascia with meticulous hemostasis.Rhomboid flap technique: involve closure of the defect after excision of all sinuses with Rhomboid flap of skin and subcutaneous tissue

PROCEDURE

Karydakis technique

The patients were hospitalized, and the site of the operation was shaved on the day of the surgery. All Patients were operated on under spinal anesthesia. Antibiotic was administered to all patients as prophylaxis 60 minutes prior to the surgery. An adhesive tape was used to part the buttocks. The patients were placed in the jack-knife position. (Fig. 1). Methylene blue was injected without pressure through the external opening to delineate the sinus. The operation site was cleaned with 10% povidone-iodine. All sinus tracts were resected en bloc via elliptical incision down to presacral fascia with meticulous hemostasis.the long axis of the ellipse is parallel to the midline and 2cm from it.undercutting incision is made along the whole length 1cm below the skin surface then unrolling the flap over the midline.

PROCEDURE

open technique

The patients were hospitalized, and the site of the operation was shaved on the day of the surgery. All Patients were operated on under spinal anesthesia. Antibiotic was administered to all patients as prophylaxis 60 minutes prior to the surgery. An adhesive tape was used to part the buttocks. The patients were placed in the jack-knife position. (Fig. 1). Methylene blue was injected without pressure through the external opening to delineate the sinus. The operation site was cleaned with 10% povidone-iodine. All sinus tracts were resected en bloc via elliptical incision down to presacral fascia with meticulous hemostasis.Open procedure involved a wide excision of the pilonidal sinus tract and healing by secondary intention.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2017-12-01
Completion
2019-02-01

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Read the full study record

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View NCT04017260 on ClinicalTrials.gov