Unroofing Curettage for Pilonidal Disease

NCT ID: NCT05339828

Last Updated: 2022-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-27

Study Completion Date

2022-05-05

Brief Summary

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

Detailed Description

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Sacrococcygeal pilonidal disease (SPD) is a well-known chronic inflammatory condition that affects young adults; There are many treatment options available today, from simple non-surgical methods to extensive flap procedures. However, elaborate treatment strategies can turn this easily treatable disease into a long-term surgical ordeal, causing complications worse than the primary disease itself.

While, UC is considered safe and effective for treating simple SPD, its suitability for treating complex disease is poor and controversial. To date, no studies have investigated the efficacy of UC specifically when treating complex SPD.

This is the first study to identify and compare efficacy and outcomes after UC in patients classified into simple and complex SPD groups.

This study was conducted at the Department of Surgery of the Diskapi Training and Research Hospital in Ankara, Turkey. The local ethics committee of the institution approved the study protocol (number 27/02, dated March 22, 2016), and written informed consent was obtained from all participants.

Conditions

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Pilonidal Disease Recurrence Healing Wound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

unroofing curettage

Intervention Type PROCEDURE

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.

Interventions

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unroofing curettage

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Consecutive patients aged 18 years or older

Exclusion Criteria

* acute pilonidal abscess
* poorly controlled
* diabetes mellitus,
* immunosuppressive or coagulation disorders,
* pregnancy and/or lactation,
* other acute surgical diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara Diskapi Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Alpaslan Şahin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Engin Olcucuoglu, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara Diskapi Training and Research Hospital

Locations

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Ankara Diskapi Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 19820992 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18390914 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19333052 (View on PubMed)

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.

Reference Type RESULT
PMID: 36304191 (View on PubMed)

Other Identifiers

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Pilonidal Disease surgery

Identifier Type: -

Identifier Source: org_study_id

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