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Recruiting NCT07370714

Factors Affecting Wound Dehiscence in Pilonidal Sinus Surgery (ORIPIS)

Observational Pilonidal Sinus Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention (observational study).
Who it may be relevant to
Registry conditions: Pilonidal Sinus Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Multicenter, Prospective, Observational Study on Factors Affecting Wound Dehiscence in Pilonidal Sinus Surgery: The Impact of Anal Proximity, Morphological Stage, and Surgical Technique (ORIPIS)

Overview

The goal of this multicenter, prospective, observational study is to investigate factors associated with wound dehiscence following pilonidal sinus surgery. The main questions it aims to answer are: Does the proximity of the pilonidal sinus to the anal verge influence the risk of postoperative wound dehiscence? How do the morphological stage of the disease and the surgical technique used affect wound healing outcomes? Patients undergoing pilonidal sinus surgery as part of routine clinical care will be enrolled prospectively across multiple centers. Clinical, anatomical, and surgical characteristics-including anal proximity, morphological stage, and type of surgical technique-will be recorded. Participants will be followed postoperatively, and wound outcomes will be assessed to identify factors associated with wound dehiscence.

Interventions

  • Other No intervention (observational study)
    This is an observational study. No experimental intervention is assigned. Surgical procedures are performed as part of routine clinical care according to standard practice and are not determined by the study protocol.

Primary outcome measures

  • Postoperative Wound Dehiscence [Time frame: Within 30 days after surgery]
Secondary outcome measures (1)
  • Time to Complete Wound Healing [Time frame: Up to 90 days after surgery]

Eligibility criteria

Inclusion criteria

  • Adult patients (≥18 years of age)
  • Diagnosis of pilonidal sinus disease
  • Patients undergoing pilonidal sinus surgery as part of routine clinical care
  • Ability to provide informed consent

Exclusion criteria

  • Patients undergoing emergency surgery
  • Previous pilonidal sinus surgery at the same site
  • Inability to complete postoperative follow-up

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Etlik City Hospital — Ankara

Identifiers

NCT: NCT07370714 · AEŞH-EK-2025-290

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗