Unroofing Curettage for Pilonidal Disease

Recurrence Clinical Trial

Official title:

Unroofing Curettage for Treating Simple and Complex Sacrococcygeal Pilonidal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05339828
• Other study ID #: Pilonidal Disease surgery
• Status: Completed
• Start date: April 27, 2022
• Est. completion date: May 5, 2022

Study information

• Verified date: October 2022
• Source: Ankara Diskapi Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: May 5, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healing Wound
• Pilonidal Disease
• Recurrence

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Turkey	Ankara Diskapi Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Diskapi Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. https://doi.org/10.4174/astr.2022.103.4.244

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	After healing was complete, any new sinus orifice or discharge from the wound was defined as disease recurrence.	15 days
Secondary	complete healing time	time after surgery until the wound is completely epithelialized	15 days
Secondary	VAS pain score	Visual analog scale for pain	15 days
Secondary	time to return to daily activities	time after surgery until the to return to daily activities	15 days