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

NCT04017260 | Completed

• 1 other identifier: zagazig university
• Study Type: interventional
• Target: 175
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

pilonidal sinus, combined, sutures, drain

Outcome Measures

Primary Outcomes (2)

• operative time

  operative time for all 4 groups are measured

  intraoperative

• infection postoperative

  follow up the wound in early postoperative period

  2 weeks

Secondary Outcomes (1)

• postoperative recurrence

  1 year

Study Arms (4)

open and closed technique

EXPERIMENTAL

treatment of pilonidal sinus by open and closed approach

Procedure: open and closed approach

Rhomboid flap technique

EXPERIMENTAL

treatment of pilonidal sinus by Rhomboid flap

Procedure: Rhomboid flap technique

karydakis technique

EXPERIMENTAL

treatment of pilonidal sinus by Karydakis

Procedure: Karydakis technique

open technique

EXPERIMENTAL

treatment of pilonidal sinus by open approach

Procedure: open technique

Interventions

open and closed approach PROCEDURE

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 .

open and closed technique

Rhomboid flap technique PROCEDURE

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

Rhomboid flap technique

Karydakis technique PROCEDURE

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.

karydakis technique

open technique PROCEDURE

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.

open technique

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• PSD in intergluteal region
• between 18-35 years.
• Also those fulfilling the diagnostic criteria of Chronic discharging sinus/sinuses in natal cleft with or without surrounding tissue inflammation and with associated pain and bleeding on clinical evaluation

You may not qualify if:

• recurrent pilonidal sinus,
• patients who were terminally ill, had Uncontrolled diabetics, were Immunocompromised and immunosuppressed patients,
• had acute pilonidal abscess.

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Pilonidal Sinus

Interventions

Open Abdomen Techniques

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Intervention Hierarchy (Ancestors)

Abdominal Wound Closure Techniques; Wound Closure Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professour

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 12, 2019
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2019
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share