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NCT Number: NCT06683274

Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease

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.

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Key information

Conditions

Pilonidal Sinus Cysts Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Albert Schweitzer ziekenhuis

Dordrecht, 3318AT, Netherlands

Location status: Recruiting

Location contact

Max Goudberg

CONTACT

[email protected]

+31622577653

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 16 years of age and older
  • Symptomatic complex or recurrent pilonidal sinus disease
  • Planned for surgical treatment
  • Signed informed consent

Exclusion criteria

  • Pregnant
  • Insufficient understanding of the Dutch language or otherwise unable to give consent

Treatment and study plan

Primary outcomes

  1. Wound healing time

    Time frame: 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

    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.

Secondary outcomes

  1. Return to normal activities

    Time frame: 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

    Time to return to normal activities after surgery (in days). This will be self reported by patients through a brief checklist on which the activities (washing, dressing, sitting, work/study) should be checked when possible without discomfort.

Other outcomes

  1. Quality of Life

    Time frame: Baseline, 4-6 weeks and 6 months postoperative.

    Quality of Life, measured with EuroQol 5 dimensions, 5 levels (EQ-5D-5L) questionnaire. The questions are answered on a 5 point Likert scale. Ranging from 5-25, with 5 being the best possible outcome and 25 being the worst possible outcome. Additionally, there is a general question on a 0-100 scale, with 0 being the worst health possible and 100 being the best health possible.

  2. Pain

    Time frame: The outcome will be evaluated at each follow-up visit, at 1-3 weeks, 4-6 weeks and 6 months postoperative.

    Pain score, on a Numeric Rating Scale ranging from 0-10 with 0 representing 'no pain' and 10 representing 'the worst pain possible'

Study contacts

Contact information is provided by the study sponsor or research team.

Max Goudberg, MD

CONTACT

[email protected]

+31622577653

Sponsors and collaborators

Lead sponsor

Albert Schweitzer Ziekenhuis, Netherlands

Other

Registry information

Acronym: BATCRAC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 12, 2024
Registry last updated
Sep 30, 2025

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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