Clinical trial · Observational
Factors Affecting Wound Dehiscence in Pilonidal Sinus Surgery (ORIPIS)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pilonidal Sinus Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention (observational study) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pilonidal Sinus Surgery Patients
- description
- This cohort includes adult patients undergoing pilonidal sinus surgery as part of routine clinical care at participating centers. The study is observational in nature, and no experimental intervention is assigned. Surgical technique, anatomical characteristics including proximity to the anal verge, and morphological stage of the disease are determined by the treating surgeon according to standard practice. Patients are prospectively followed after surgery, and postoperative wound outcomes are recorded for observational analysis.
- interventionNames
- Other: No intervention (observational study)
Primary outcomes (1)
- measure
- Postoperative Wound Dehiscence
- timeFrame
- Within 30 days after surgery
- description
- Wound dehiscence is defined as partial or complete separation of the surgical wound occurring after pilonidal sinus surgery, as assessed during postoperative follow-up.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available