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Completed

NCT Number: NCT04334681

Surgical Approach for Pilonidal Disease

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

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Key information

Conditions

Pilonidal Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

About this study

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 who are well followed up will be included in the study. Demographic features will be recorded. Patients will be divided into two groups, the un-roofing curettage group (UC group) and the Modified Limberg Flap group (LF group). Surgery time, hospital stay, return to work time, recovery time, painless walking time, days, painless sitting time in the toilet, days, postoperative VAS, and recurrence will be compared between both groups. In addition, mobilization time, days, recovery time, days, exclusion time, days, wound infection, wound distribution will be compared between groups. The results will be analyzed with the SPSS statistics program. Factors affecting recurrence wound infection, recovery time, hospital stay, operation time, early mobilization will be evaluated by univariate and multivariate logistic regression analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients between the ages of 18 and 70
  • Patients with sufficient registration information
  • Telephone-accessible patients

Exclusion criteria

  • Patients under the age of 18
  • Patients over 70 years old
  • Common gluteal disease
  • Diabetes mellitus
  • Connective tissue disease

Treatment and study plan

Un-roofing curettage method

Procedure

In this method, the roof of the pilonidal cyst is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis.

Modified Limberg Flap Group

Procedure

In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the modified Limberg flap method.

Primary outcomes

  1. Mobilization Time,Days

    Time frame: 15 days

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

  2. Number of Participants With Recurring Disease

    Time frame: 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

  3. Operation Time

    Time frame: operation time, up to 100 minutes

    Mean operation time was determined in minutes in both groups.

  4. Hospitalization Time

    Time frame: Hospitalization time, up to 15 days

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

Sponsors and collaborators

Lead sponsor

Konya Meram State Hospital

Other

Registry information

Official study title

Unroofing Curettage Versus Modified Limberg Flap in Pilonidal Disease: A Retrospective Cohort Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2020
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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