NCT05892198

Brief Summary

Sacrococcygeal pilonidal disease (PND) is a common entity affecting the skin and subcutaneous tissue of the upper portion of the natal cleft of the buttocks. It is characterized by the presence of sinus tracts with recurrent inflammation and infection. It poses a significant healthcare problem due to its related morbidity, impaired quality of life, and financial costs.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
Last Updated

June 7, 2023

Status Verified

May 1, 2023

Enrollment Period

5.5 years

First QC Date

May 28, 2023

Last Update Submit

May 28, 2023

Conditions

Pilonidal Sinus

Keywords

sacrococcygeal pilonidal sinusprimary closurelimberg flaprotational flap

Outcome Measures

Primary Outcomes (2)

  • Select the best operative technique as regard the number and distribution of the pits in pilonidal sinus cases.

    best surgical option based on pits location

    6 months

  • Recurrence rate

    how many cases developed recurrence

    6 months - 1 year

Secondary Outcomes (1)

  • the incidence of complications such as: wound infection, wound dehiscence, postoperative pain.

    1 month

Study Arms (3)

primary closure

ACTIVE COMPARATOR

The group in which the pits location were in midline ,underwent excision with primary closure

Procedure: surgery

Rhomboid flap group

ACTIVE COMPARATOR

in which more lateral pits and pits located \<2cm from mid line natal cleft

Procedure: surgery

Rotational flap group

ACTIVE COMPARATOR

in which more lateral pits and pits located \>2cm from mid line natal cleft

Procedure: surgery

Interventions

surgeryPROCEDURE

surgery with primary closure, Rhomboid flap , or Rotational flap

Also known as: surgical procedure
Rhomboid flap groupRotational flap groupprimary closure

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both sexes
  • aging between 18- 60 years old
  • who underwent surgical intervention for the pilonidal sinus (Either primary or recurrent)
  • The surgical intervention includes excision with primary closure or lay open technique, Rhomboid flap and rotational flap.

You may not qualify if:

  • surgically unfit due to commodities.
  • those who lost follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pilonidal Sinus

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of general surgery

Study Record Dates

First Submitted

May 28, 2023

First Posted

June 7, 2023

Study Start

January 1, 2015

Primary Completion

June 30, 2020

Study Completion

December 30, 2021

Last Updated

June 7, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share