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Pilonidal Excision Versus Endoscopic Surgery (PEVES)

S

St Helens & Knowsley Teaching Hospitals NHS Trust

Status

Completed

Conditions

Pilonidal Sinus

Treatments

Procedure: EPSiT
Procedure: Excision

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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