NCT05356208

Brief Summary

Single-center cohort study of 10-year risk of treatment failure after cleft-lift under tumescent local analgesia for pilonidal sinus disease

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
Last Updated

March 29, 2023

Status Verified

April 1, 2022

Enrollment Period

13.8 years

First QC Date

April 26, 2022

Last Update Submit

March 27, 2023

Conditions

Pilonidal Sinus

Keywords

Cleft-liftTumescent local analgesia

Outcome Measures

Primary Outcomes (1)

  • Treatment failure assessed by clinical assessment or by questionnaire

    Incomplete wound healing or recurrence after complete wound healing

    10 years

Secondary Outcomes (2)

  • Chronic pain related to cicatrix

    10 years

  • Cosmetic appearance of the cicatrix

    10 years

Eligibility Criteria

Age14 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with moderate to complex pilonidal sinus disease referred to a secondary and tertiary care hospital. Patients with history of surgery for pilonidal sinus disease are included in the cohort.

You may qualify if:

  • Undergoing pit-pick at Nordsjællands Hospital during the study period

You may not qualify if:

  • Non-Danish residents
  • Patients planned for general anesthesia were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordsjaellands Hospital

Hillerød, 3400, Denmark

Location

Related Publications (2)

  • Bertelsen CA. Cleft-lift operation for pilonidal sinuses under tumescent local anesthesia: a prospective cohort study of peri- and postoperative pain. Dis Colon Rectum. 2011 Jul;54(7):895-900. doi: 10.1007/DCR.0b013e31820ee852.

    PMID: 21654258BACKGROUND

  • Svarre KJ, Serup CM, Kanstrup CTB, Kleif J, Bertelsen CA. Long-term outcome after Bascom's cleft-lift procedure under tumescent local analgesia for pilonidal sinus disease: a cohort study. Colorectal Dis. 2023 Apr;25(4):707-716. doi: 10.1111/codi.16420. Epub 2022 Nov 28.

    PMID: 36401803RESULT

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2022

First Posted

May 2, 2022

Study Start

August 1, 2007

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

March 29, 2023

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

fter de-identification, individual participant data will be made available to investigators who provide a methodologically sound proposal for meta-analyses.

Locations

DK(1)