Evaluation of Rhomboid Flap Outcome in the Surgical Treatment of Recurrent Sacrococcygeal Pilonidal Sinus vs. Deep Suturing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 30
- Primary Endpoint
- Primary Outcome of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Primary Outcome of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.
Time Frame: 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 Outcomes
- Secondary Outcome (subsidiary)of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.(baseline)
Investigators
Ahmed Dify Kamal
Principal Investigator
Assiut University