Pilonidal Excision Versus Endoscopic Surgery

St Helens & Knowsley Teaching Hospitals NHS Trust39 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pilonidal Sinus

Interventions

EPSiTPROCEDURE

Specialised fistuloscope to indentify sinus tracts, cautery tracts, remove causative hair, irrigation.

ExcisionPROCEDURE

Surgery to remove all affected tissue, followed by wound closure.

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

St Helens & Knowsley Hospitals NHS Trust

Prescot, Merseyside, United Kingdom

Outcomes

Primary Outcomes

Complication rate

As described by Dindo et al 2004

Time frame: 12 months

Secondary Outcomes

Quality of life (QoL)

QoL utilising validated tool

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.