Comparative Study Between Wide Local Excision and Minimal Excision of Pilonidal Sinus

Pilonidal Sinus Clinical Trial

Official title:

Comparative Study Between Wide Local Excision and Minimal Excision of Pilonidal Sinus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06021392
• Other study ID #: Techniques of PNS excision
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: September 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Comparative study between wide local excision and minimal excision of pilonidal sinus

Description:

Pilonidal sinus (PNS) disease is distributed in young adults who are supposed to be healthy with maximum productivity. Wide local excision creates a tissue gap, while the concept of minimal excision preserves healthy tissues with minimal tissue gap.

Pilonidal disease is a frequent suppurative condition that occurs twice as often in men as in women, usually between the ages of 15 and 30. Pilonidal disease is located beneath the skin of the sacro-coccygeal region. It presents acutely as an abscess under tension while the chronic form gives rise to intermittent discharge from pilonidal sinus(es). Diagnosis is clinical and usually straightforward. In the large majority of cases, treatment is surgical but there is no consensus as to the 'ideal' technique. Acute abscess must be evacuated and an off-midline incision seems preferable. Excision is the standard definitive treatment but the choice of wide versus limited excision on the school of thought. Minimal excision or debridement of the sinus and/or cavity through a midline or a separate paramedian excision can also be performed, leaving the wounds open or closed. These methods are simple and cost-efficient, and associated with low pain, rapid healing, and a rapid return to normal activity. A disadvantage is the higher recurrence rate; however, these methods can be used repeatedly for recurrences. Although recurrence rates seem high at first glance, the procedures can be successfully repeated for recurrences, achieving healing rates of over 90% for 1-2 interventions. Future well-designed trials are necessary to aid patient selection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2
• Est. completion date: October 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients complaining of primary PNS and Recurrent PNS following Minimal excision

Exclusion Criteria:

• Recurrent PNS following wide local excision

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

Procedure:
• Z plasty and minimal excision of pilonidal sinus
The investigators will perform a " Z plasty " procedure and Minimal excision procedure for patients complaining of pilonidal sinus and the investigators will compare the outcomes and rate of recurrence of these two procedures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abanoub emad fayez

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recurrence	Showing each of both procedures efficacy in decreasing rate of recurrence of PNS	In about 6 month follow up