NCT04418336

Brief Summary

Aim of the work To compare Sinus Laser closure versus lay open technique versus Endoscopic pilonidal sinus treatment as regards recurrence rate, operative data, postoperative pain, intra and postoperative complications, healing time and return to daily activity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2021

Completed
Last Updated

June 9, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

June 3, 2020

Last Update Submit

June 5, 2020

Conditions

Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Recurrence of pilonidal sinus after treatment

    one year

Study Arms (3)

Endoscopic Pilonidal sinus treatment (EPSIT)

ACTIVE COMPARATOR

Endoscopic Pilonidal sinus treatment (EPSIT)

Procedure: Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique

Sinus Laser Closure (SiLaC)

ACTIVE COMPARATOR

Sinus Laser Closure (SiLaC)

Procedure: Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique

lay open technique

ACTIVE COMPARATOR

lay open technique

Procedure: Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique

Interventions

Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open techniquePROCEDURE

Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in sacrococcygeal Pilonidal sinus treatment

Endoscopic Pilonidal sinus treatment (EPSIT)Sinus Laser Closure (SiLaC)lay open technique

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with symptoms from sacrococcygeal pilonidal sinus .

You may not qualify if:

  • Abscess formation
  • Immunodeficiency.
  • Patients with congenital asymptomatic pits.
  • Patient with psychiatric disease disabling surgical intervention. . Pregnant females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Central Study Contacts

Mohamed Arnouse

CONTACT

01099222561drmhamdy@mans.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 5, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 2, 2021

Last Updated

June 9, 2020

Record last verified: 2020-05

Locations

EG(1)