NCT05027607

Brief Summary

Single-center cohort study of long-term results after pit-pcik for pilonidal sinus disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-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
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
Last Updated

March 29, 2023

Status Verified

August 1, 2021

Enrollment Period

13.8 years

First QC Date

August 25, 2021

Last Update Submit

March 27, 2023

Conditions

Pilonidal Sinus of Natal Cleft

Keywords

Pilonidal sinusPit-pickRecurrencePainDay Surgery

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

Interventions

Bascom's pit-pickPROCEDURE

Pit-pick procedure of simple pilonidal sinus disease in the natal cleft in a day-surgery setting.

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 simple pilonidal sinus disease referred to a secondary and tertiary care hospital. Prior surgery for pilonidal sinus disease included in the cohort.

You may qualify if:

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

You may not qualify if:

  • Included in project investigating novel wound dressing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordsjaellands Hospital

Hillerød, 3400, Denmark

Location

Related Publications (2)

  • Colov EP, Bertelsen CA. Short convalescence and minimal pain after out-patient Bascom's pit-pick operation. Dan Med Bull. 2011 Dec;58(12):A4348.

    PMID: 22142576BACKGROUND

  • Serup CM, Svarre KJ, Kanstrup CTB, Kleif J, Bertelsen CA. Long-term outcome after Bascom's pit-pick procedure for pilonidal sinus disease: A cohort study. Colorectal Dis. 2023 Mar;25(3):413-419. doi: 10.1111/codi.16383. Epub 2022 Nov 13.

    PMID: 36268754BACKGROUND

MeSH Terms

Conditions

Pilonidal SinusRecurrencePain

Condition Hierarchy (Ancestors)

CystsNeoplasmsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Claus A Bertelsen, PhD

    Department of Surgery, Copenhagen University Hospital - Nordsjaellands Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2021

First Posted

August 30, 2021

Study Start

August 1, 2007

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

March 29, 2023

Record last verified: 2021-08

Locations

DK(1)