Rhomboid Flap vs. Deep Suturing in Recurrent Pilonidal Sinus

Not yet recruiting

• Conditions: Pilonidal Sinus Infected

• Registration Number: NCT06152952
• Lead Sponsor: Assiut University

Brief Summary

This prospective clinical trial aims to compare the perioperative outcomes of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.

Detailed Description

Pilonidal disease derives its name from Latin- pilus meaning "hair," and nidus meaning "nest" . The source of pilonidal disease is thought to be a deep intergluteal sulcus. It is widely accepted that the establishment of the pilonidal sinus results from the penetration of shed hair shafts through the skin, which ultimately leads to an acute or chronic infected site .

Pilonidal disease is largely considered a surgical disease, especially in acute instances with secondary infection and abscess. Infection or abscess requires incision and drainage. Definitive treatment is delayed the majority of the time if there is an acute infection or abscess until after the infection has been addressed. Surgical options for chronic disease are numerous and can include "pit picking," curettage, aspiration, unroofing, or surgical excision. Defects can be closed primarily, with flaps or grafts, or allowed to heal by secondary intention .

The most serious problem of the various surgical approaches proposed is the recurrence rate, ranging from 0% to 40% .

The surgical treatment of patients with recurrent disease does not differ from the surgical treatment of primary pilonidal disease. In case of a recurrence with an abscess, incision and drainage prevail, while in case of chronic recurrent disease, a flap based procedure may be indicated following sinus excision with scarring, like the rhomboid flap .

Study Timeline

• Study First Submitted: 2023-11-12
• Study First Submitted QC: 2023-11-29
• Status Verified: 2023-12
• Study Start: 2023-12
• Study First Posted: 2023-12-01
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-05
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adult patients aged between 18 and 60 years;
• Patients with one or two small inactive sinuses will be included for easier excisional procedures;
• Previous intervention for pilonidal disease whether surgical or non-surgical;

Exclusion Criteria

1 - Patients with an acute abscess. 2- Patients with mall inactive pilonidal sinus disease. 3- Age beyond the previous limits. 4- Patients with primary pilonidal disease. 5- Refusal to participate in the study. 6- Unfit for anaesthesia and surgery. 7- Patients with malignant neoplasms or inflammatory bowel disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.	baseline	Primary Outcome : Postoperative recurrence rate. Recurrence will be defined as the additional outbreak of signs and symptoms of pilonidal disease after a disease-free interval following complete wound healing

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome (subsidiary)of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.	baseline	Secondary Outcome (subsidiary): 1. Operative time.; 2. Postoperative pain.; 3. The incidence of other complications.; 4. Postoperative cosmetic outcome.; 5. The duration to walk, sit on toilet free from pain.; 6. The duration till complete daily activities.