NCT05339828

Brief Summary

This study aimed to investigate the outcomes of patients who underwent UC as the primary intervention for simple or complex SPD

Trial Health

87
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

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

February 26, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

April 27, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2022

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

5 days

First QC Date

February 26, 2022

Last Update Submit

October 25, 2022

Conditions

Pilonidal DiseaseRecurrenceHealing Wound

Keywords

complex pilonidal diseaseunroofing curettagerecurrenceLay open technique

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    After healing was complete, any new sinus orifice or discharge from the wound was defined as disease recurrence.

    15 days

Secondary Outcomes (3)

  • complete healing time

    15 days

  • VAS pain score

    15 days

  • time to return to daily activities

    15 days

Study Arms (1)

unroofing curettage

Surgery was performed with the patient lying in the prone position under local anesthesia. Next, a local anesthetic agent comprising a solution of lidocaine (20 mg/mL) and adrenaline (0.0125 mg/mL) was diluted with distilled water in a 1:2 ratio and applied. The tract was identified by passing small artery forceps along its length and was then opened by cutting directly down onto the forceps. The sinus and all its tracts were completely unroofed, and the base was curetted to remove all necrotic content, hair, and granulation tissue using a dry gauze. The fibrotic back wall was left as intact as possible to avoid delayed healing.

Procedure: unroofing curettage

Interventions

unroofing curettagePROCEDURE

Surgery was performed with the patient lying in the prone position under local anesthesia. The tract was identified by passing small artery forceps along its length and was then opened by cutting directly down onto the forceps. The sinus and all its tracts were completely unroofed, and the base was curetted to remove all necrotic content, hair, and granulation tissue using a dry gauze. The fibrotic back wall was left as intact as possible to avoid delayed healing. Hemostasis was achieved using diathermy with no drainage needed.

unroofing curettage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients aged 18 years or older who applied for simple and complex SPD treatment between April 2016 and September 2018 and preferred the UC surgery from all the treatment options offered by the physician.

You may qualify if:

  • Consecutive patients aged 18 years or older

You may not qualify if:

  • acute pilonidal abscess
  • poorly controlled
  • diabetes mellitus,
  • immunosuppressive or coagulation disorders,
  • pregnancy and/or lactation,
  • other acute surgical diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Diskapi Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (4)

  • Kepenekci I, Demirkan A, Celasin H, Gecim IE. Unroofing and curettage for the treatment of acute and chronic pilonidal disease. World J Surg. 2010 Jan;34(1):153-7. doi: 10.1007/s00268-009-0245-6.

    PMID: 19820992BACKGROUND

  • McCallum IJ, King PM, Bruce J. Healing by primary closure versus open healing after surgery for pilonidal sinus: systematic review and meta-analysis. BMJ. 2008 Apr 19;336(7649):868-71. doi: 10.1136/bmj.39517.808160.BE. Epub 2008 Apr 7.

    PMID: 18390914BACKGROUND

  • Karakayali F, Karagulle E, Karabulut Z, Oksuz E, Moray G, Haberal M. Unroofing and marsupialization vs. rhomboid excision and Limberg flap in pilonidal disease: a prospective, randomized, clinical trial. Dis Colon Rectum. 2009 Mar;52(3):496-502. doi: 10.1007/DCR.0b013e31819a3ec0.

    PMID: 19333052BACKGROUND

  • Olcucuoglu E, Sahin A. Unroofing curettage for treatment of simple and complex sacrococcygeal pilonidal disease. Ann Surg Treat Res. 2022 Oct;103(4):244-251. doi: 10.4174/astr.2022.103.4.244. Epub 2022 Oct 7.

    PMID: 36304191RESULT

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Engin Olcucuoglu, MD

    Ankara Diskapi Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2022

First Posted

April 21, 2022

Study Start

April 27, 2022

Primary Completion

May 2, 2022

Study Completion

May 5, 2022

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Nothing

Locations

TU(1)