Karydakis Flap Versus Burow's Triangle Advancement Flap in the Surgery of Sacrococcygeal Pilonidal Sinus Disease

Not Applicable

Recruiting

• Conditions: Pilonidal Sinus; Sacrococcygeal Pilonidal Disease
• Interventions: Procedure: Karydakis Flap Procedure; Procedure: Burow's Triangle Advancement Flap Procedure

• Registration Number: NCT05289297
• Lead Sponsor: Istanbul Sultanbeyli State Hospital

Brief Summary

In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in terms of complications, time to return to normal activity, and recurrence.

Detailed Description

Pilonidal sinus disease (PSD) is a chronic and inflammatory disease that is often generated in the sacrococcygeal region. It is commonly observed in puberty and young adult period and usually affects men. The incidence of pilonidal sinus disease is 26:100,000 and rising globally.

PSD risk factors contain young age, obesity, male gender, Mediterranean ethnicity, deep natal cleft, hairiness, and poor hygiene. It has been shown that PSD incidence increases in parallel with body weight. The precise etiology of pilonidal sinus disease is unclear. Many conservative and surgical methods have been described in treating pilonidal sinus disease. After the sinus area is excised, excision with laying open (secondary healing), excision with primary closure, marsupialization, and various flap techniques can be applied in surgical treatment. The primary principle in treatment is to ensure that the patient returns to normal life as soon as possible and eliminate recurrences. Although the best surgical technique in treating pilonidal sinus is controversial, the ideal operation should be cost-effective, simple to perform, short hospital stay, and have a low recurrence and complication rates. There is no definite consensus on an ideal technique yet.

In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in our clinic in terms of complications (wound dehiscence, seroma, hematoma, surgical site infection), time to return to normal activity, and recurrence.

Study Timeline

• Study First Submitted: 2022-03-13
• Study First Submitted QC: 2022-03-13
• Study First Posted: 2022-03-21
• Study Start: 2022-06-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients between the ages of 18-65
• Primary pilonidal sinus disease
• No abscess and absence of active infection during the operation

Exclusion Criteria

• Patients under the age of 18 and over the age of 65
• Recurrent pilonidal sinus cases
• Patients with chronic comorbidities such as immunosuppression, collagen tissue disease, insulin-dependent diabetes mellitus, and neurological disease
• Patients with an ASA score of 3-4
• Patients with a body mass index greater than 35 kg/m2
• Patients with drug and alcohol addiction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Karydakis Flap Procedure	Karydakis Flap Procedure	Vertical eccentric elliptical incision down to the post-sacral fascia, complete removal of unhealthy tissue, and normal tissue around the cyst and sinus tracts. Mobilization of the medial wound edge and advancement of the skin. Flap along the midline to the post-sacral fascia and suturing its margin to the lateral wound margin.
Burow's Triangle Advancement Flap Procedure	Burow's Triangle Advancement Flap Procedure	The flap is incised along the base of the wedge-shaped defect, and a small Burow's triangle is excised on the opposite side. The skin is mobilized and shifted in the direction of the arrow to close the defect. Excising the small Burow's triangle eliminates a dog ear at the base of the flap.

Primary Outcome Measures

Name	Time	Method
Pain score according to the visual analogue scale	1-3 days	Postoperative pain after surgery ( measured by the visual analog score with 1 being minimum score and 10 being maximum score)
Postoperative wound healing time	4 to 6 weeks	Number of weeks of complete duration epithelialization of the wound
Procedure-related complications	1 to 6 weeks	Number of complications; related to the surgery, Type (wound dehiscence, seroma, hematoma, surgical site infection)
Time to return to normal activity	4 to 6 weeks	The number of weeks it passes the patient to return to normal activity.

Secondary Outcome Measures

Name	Time	Method
Recurrence of Pilonidal Sinus	6 - 12 months	Number of patients with recurrence pilonidal disease

Trial Locations

Locations (1)

Istanbul Sultanbeyli State Hospital; 🇹🇷 Istanbul, Turkey