Pilonidal Excision Versus Endoscopic Surgery (PEVES)

St Helens & Knowsley Teaching Hospitals NHS Trust

Status: Completed

Conditions: Pilonidal Sinus

Treatments: Procedure: Excision; Procedure: EPSiT

Study type: Interventional

Funder types: Other

Identifiers

NCT03923621

RBN955/V1

Details and patient eligibility

About

Compare clinical outcomes of endoscopic pilonidal sinus treatment (EPSiT) with excision treatment with a randomised clinical trial.

Full description

Primary outcome: complication rate Secondary outcomes: Quality of life, recurrence rate, length of stay, post operative pain (NRS), return to work time, time to complete wound healing, resource use.

Allocation ratio 2:1

Enrollment: 39 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA I or II
• Pilonidal disease <3 previous treatments
• Previous incision and drainage allowed
• Over 16 years

Exclusion criteria

• Co-morbidity >ASA II
• Unable to consent themselves
• Under 16 years
• Vulnerable adults

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

39 participants in 2 patient groups

Experimental - EPSiT

Experimental group

Description:

Endoscopic Pilonidal Sinus Treatment

Treatment:

Procedure: EPSiT

Control - excision

Active Comparator group

Description:

Excision treatment

Treatment:

Procedure: Excision