Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease
BATCRAC
1 other identifier
observational
58
1 country
1
Brief Summary
The goal of this observational study is to improve care for patients with complex or recurrent pilonidal sinus disease by developing and implementing a best practice care pathway, including a standardized cleft lift operation. The main question it aims to answer is: Does a best practice care pathway with standardized cleft lift operation lead to shorter wound healing time and time to return to normal activities, compared to current standard care, with traditional excision techniques.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedStudy Start
First participant enrolled
February 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
September 30, 2025
September 1, 2025
1.9 years
November 7, 2024
September 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound healing time
Time to wound healing (in days), this will be self reported by patients when the skin is completely closed, and will be validated through clinical assessment by the surgeon.
The outcome will be evaluated at each follow-up visit, at 1-3 weeks, 4-6 weeks and 6 months postoperative. If necessary, additional visits will be planned
Secondary Outcomes (1)
Return to normal activities
The outcome will be evaluated at each follow-up visit, at 1-3 weeks, 4-6 weeks and 6 months postoperative. If necessary, additional visits will be planned
Other Outcomes (2)
Quality of Life
Baseline, 4-6 weeks and 6 months postoperative.
Pain
The outcome will be evaluated at each follow-up visit, at 1-3 weeks, 4-6 weeks and 6 months postoperative.
Study Arms (2)
Control cohort
Current practice cohort
Interventional cohort
Best practice care pathway with standardized Bascom cleft lift
Eligibility Criteria
Patients with (symptomatic) complex or recurrent pilonidal sinus disease, who will be planned for surgical treatment.
You may qualify if:
- years of age and older
- Symptomatic complex or recurrent pilonidal sinus disease
- Planned for surgical treatment
- Signed informed consent
You may not qualify if:
- Pregnant
- Insufficient understanding of the Dutch language or otherwise unable to give consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Albert Schweitzer ziekenhuis
Dordrecht, 3318AT, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Smeenk, MD, PhD
Albert Schweitzer Ziekenhuis, Netherlands
- PRINCIPAL INVESTIGATOR
Boudewijn Toorenvliet, MD, PhD
Ikazia ziekenhuis
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD candidate
Study Record Dates
First Submitted
November 7, 2024
First Posted
November 12, 2024
Study Start
February 20, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share