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OpenTrials
Completed

NCT Number: NCT05569135

Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease

This study aims to investigate the effect of laser ablation (LA) in minimally invasive management of pilonidal disease (PD).

Data of the patients with PD who were eligible for simple debridement have been prospectively collected since March 2018, when laser ablation treatment came into use in our institution. Laser ablation treatment was offered to all eligible patients. All the patients underwent debridement (removal of hair and/or necrotic tissues through pits using a clamp/curette/brush) of PD; LA was added to the procedure in patients who were willing to have LA. The surgical outcome of two procedures was compared. The primary outcome measure was recurrence at 36 months.

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Key information

Conditions

Pilonidal Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medipol Bahcelievler Hospital

Istanbul, Other (Non U.s.), 34196, Turkey (Türkiye)

Who can participate

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

Inclusion criteria

  • Patients with Class III, IV, and V pilonidal disease according to Tezel Navicular Area Classification
  • Patients who underwent debridement for pilonidal disease

Exclusion criteria

  • Patients with acute abscess (Tezel Class II)
  • Antibiotic use within 4 weeks before surgery
  • Patients lost to follow-up at 3,7 and 30 days; 6, 12 and 36 months

Treatment and study plan

Laser ablation

Device

A diode-laser that has been reported to be safe and effective in several treatments including pilonidal disease, anal fistula, hemorrhoids, and vascular ablation was used to obtain shrinkage of pilonidal cyst

Primary outcomes

  1. disease recurrence at 36 months

    Time frame: 36 months

    Any ongoing or recurrent sypmtoms were recorded

Secondary outcomes

  1. Complications after the procedure

    Time frame: 1 month

    Safety of the procedure

  2. Incidence of adverse events

    Time frame: 1 month

    Safety of the procedure

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease: Retrospective Analysis of Mid-term Outcome

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Oct 6, 2022
Registry last updated
Oct 6, 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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