NCT04334681

Surgical Approach for Pilonidal Disease

Completed Results posted Last updated 27 October 2022

What this trial tests

trial testing Un-roofing curettage method in Pilonidal Disease in 278 participants. Completed in 1 October 2020.

Timeline

2 April 2020

Primary endpoint
15 September 2020

1 October 2020

Quick facts

Lead sponsor	Konya Meram State Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	278
Start date	2 April 2020
Primary completion	15 September 2020
Estimated completion	1 October 2020
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Un-roofing curettage method
• Modified Limberg Flap Group

Conditions studied

• Pilonidal Disease — all drugs for Pilonidal Disease →

Sponsor

Konya Meram State Hospital

Who can join

Adults 18 to 70, any sex, with Pilonidal Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mobilization Time,Days Primary · 15 days

Time to return to the daily activities of the patients were measured.

Group	Value	95% CI
UC Group	3.21	± 3.7
MLF Group	12.3	± 7.3

Number of Participants With Recurring Disease Primary · Number of Participants with Recurring Disease, up to five years

It has been reported in the literature that a five or ten year follow-up period is required for the effective evaluation of recurrence. In both groups, the number of recurrent patients during the follow-up period will be determined. Observation of the following findings on physical examination made a diagnosis of recurrence; * New sinus orifice formation, * Or discharge from the sinus orifice

Group	Value	95% CI
MLF Group	6
UC Group	2

Operation Time Primary · operation time, up to 100 minutes

Mean operation time was determined in minutes in both groups.

Group	Value	95% CI
UC Group	11.44	± 3.56
MLF Group	52.47	± 7.92

Hospitalization Time Primary · Hospitalization time, up to 15 days

In both groups, hospitalization will be determined as a day.

Group	Value	95% CI
UC Group	0.24	± 0.45
MLF Group	1.07	± 0.26

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

UC Group

Serious: 1/135 (1%)

Deaths: 0/135

LF Group

Serious: 2/143 (1%)

Deaths: 0/143

Serious adverse events (2 terms)

Reaction	System	UC Group	LF Group
Hemorrhage	Injury, poisoning and procedural complications	—	—
Hematoma	Injury, poisoning and procedural complications	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	UC Group	LF Group
Wound İnfection	Skin and subcutaneous tissue disorders	—	—
Wound dehiscence	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Hemorrhage, Hematoma.

Data from ClinicalTrials.gov NCT04334681 adverse events section.

Sponsor's own description

In our hospital, between January 2013 and January 2017, those operated with the Modified Limberg flap method after the Rhomboid excision due to pilonidal disease, and those operated with the un-roofing curettage method will be screened retrospectively. Patients will be divided into two groups as Un-roofing curettage group (UC group) and the Modified Limberg Flap group (LF group). Operation time, hospital stay time, return to work time, recovery time, Time to walk without pain, days, Time to sit on the toilet without pain, days, Postoperative VAS and recurrence will be compared between both groups

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.