NCT04599517

Brief Summary

There is no consensus on which procedure is the ideal surgical method in the treatment of sacrococcygeal pilonidal disease (SPD). The study aimed to retrospectively screen the cases that had undergone surgical treatment for SPD in the last 15 years in four different tertiary Stage hospitals and analyze the most frequently used surgical treatment method and its results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,748

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 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

First Submitted

Initial submission to the registry

October 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 22, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

October 18, 2020

Last Update Submit

January 5, 2021

Conditions

Keywords

pilonidalsurgeryhealing

Outcome Measures

Primary Outcomes (7)

  • Type of surgery method

    The ratio of each type of surgery to the study population

    15 day

  • duration of surgery

    The average operation time of the determined types of surgery will be determined.

    15 day

  • hospitalization time

    The average hospitalization time of the determined types of surgery will be determined.

    15 day

  • Type of anesthesia

    the ratio of anesthesia methods to the study population

    15 day

  • day time return to work

    return to work time will be found as average days for specified surgery types.

    15 days

  • complete healing time

    Complete healing time will be found as average days for specified surgery types

    15 days

  • recurrence

    recurrence rate in the study population

    15 days

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients aged 14-80 years who underwent surgery for pilonidal sinus constitute the study population.

You may qualify if:

  • All patients between the ages of 14-80 who underwent surgery for pilonidal sinus

You may not qualify if:

  • unregulated diabetes mellitus
  • collagen tissue disease
  • decompensated cardiovascular disease
  • cases with missing follow-up information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

Location

Related Publications (3)

  • Johnson EK, Vogel JD, Cowan ML, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons' Clinical Practice Guidelines for the Management of Pilonidal Disease. Dis Colon Rectum. 2019 Feb;62(2):146-157. doi: 10.1097/DCR.0000000000001237. No abstract available.

    PMID: 30640830BACKGROUND
  • Hull TL, Wu J. Pilonidal disease. Surg Clin North Am. 2002 Dec;82(6):1169-85. doi: 10.1016/s0039-6109(02)00062-2.

    PMID: 12516846BACKGROUND
  • Stauffer VK, Luedi MM, Kauf P, Schmid M, Diekmann M, Wieferich K, Schnuriger B, Doll D. Common surgical procedures in pilonidal sinus disease: A meta-analysis, merged data analysis, and comprehensive study on recurrence. Sci Rep. 2018 Feb 15;8(1):3058. doi: 10.1038/s41598-018-20143-4.

    PMID: 29449548BACKGROUND

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
PRINCIPAL INVESTIGATOR
PI Title
prinicipal investigator

Study Record Dates

First Submitted

October 18, 2020

First Posted

October 22, 2020

Study Start

October 22, 2020

Primary Completion

November 25, 2020

Study Completion

December 15, 2020

Last Updated

January 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

No plans to make individual participant data (IPD) available to other researchers

Locations