Staging System for Chronic Symptomatic Pilonidal Sinus Disease

Pilonidal Sinus Clinical Trial

Official title:

A Proposed Staging System for Chronic Symptomatic Pilonidal Sinus Disease and Results in Patients Treated With Stage-based Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712970
• Other study ID #: TrabzonNTRH
• Status: Completed
• Phase: N/A
• First received: March 5, 2016
• Last updated: March 14, 2016
• Start date: January 2011
• Est. completion date: June 2015

Study information

• Verified date: March 2016
• Source: Trabzon Numune Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

A staging system was defined based on morphological extent of disease (stage I to stage IV for primary disease, and stage R for recurrent disease). Specific surgical technique was used for each stage. Demographics, perioperative data, short-term and long-term outcomes were evaluated according to the disease stage.

Description:

The collected data of patients who underwent surgery for the treatment of pilonidal sinus disease prior to June 2011 were analyzed. Following this analysis, a staging system was defined based on morphological extent of disease (stage I to stage IV for primary disease, and stage R for recurrent disease). Specific surgical technique was used for each stage. "Pit-picking" technique was performed under local anesthesia on an outpatient basis in stage I and stage IIa patients. For stage IIb and stage III patients, the Bascom Cleft Lift /modified Bascom Cleft Lift techniques were performed. For stage IV patients, the rhomboid excision with the Limberg flap technique was used. Demographics, perioperative data, short-term and long-term outcomes were evaluated according to the disease stage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals with symptomatic pilonidal sinus disease.

Exclusion Criteria:

• <18 y

• Pilonidal sinus disease which identified incidentally and which presented with acute abscesses were not included to the staging system.

• Patients who were treated without the use of the suggested algorithm were excluded from the analysis.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

Procedure:
• pit-picking technique
midline pits were excised removing a minimal amount of tissue (with a margin of skin of <1 mm). Incision of 1-2 cm in length was performed parallel to the most convenient side of the midline to be curetted of the chronic abscess cavity. All infected granulation tissue and hair were removed. After establishing hemostasis, the area of the excised midline pits was approximated by absorbable sutures.
• Bascom Cleft Lift
The upper end of the incision was made 1-2 cm lateral to the midline on the more affected side and this was continued vertically over a distance of 1-2 mm from the midline pits. The lower end was fashioned from the midline in a V-shape in order to prevent a dog-ear deformity. The skin on this side of the natal cleft was then elevated and excised. The skin on the opposite side was undermined to the distance required to allow primary closure of the defect away from the midline without tension. Sinus tissue and its extensions were excised. The incision was then closed subcuticularly by absorbable polyglecaprone (3-0), after which a few interrupted mattress polyglecaprone (3-0) buttress sutures were also inserted.
• Rhomboid excision with the Limberg Flap
The area to be excised was mapped on the skin in a rhomboid form, and the flap was designed. The skin incision was deepened to the postsacral fascia. The flap was fully mobilized and transposed medially to fill the defect without tension. The wound was closed in two layers: the subcutaneous tissue with absorbable (2/0 polyglactin) sutures and the skin with nonabsorbable (3/0 polypropylene) interrupted mattress suture
• Other flap techniques
Bascom Cleft lift as described above, Rhomboid excision with the Limberg Flap as described above, V-Y advancement flap, Z-Plasty

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Trabzon Numune Training and Research Hospital	Karadeniz Technical University

References & Publications (6)

Bascom J, Bascom T. Utility of the cleft lift procedure in refractory pilonidal disease. Am J Surg. 2007 May;193(5):606-9; discussion 609. — View Citation

Can MF, Sevinc MM, Hancerliogullari O, Yilmaz M, Yagci G. Multicenter prospective randomized trial comparing modified Limberg flap transposition and Karydakis flap reconstruction in patients with sacrococcygeal pilonidal disease. Am J Surg. 2010 Sep;200(3):318-27. doi: 10.1016/j.amjsurg.2009.08.042. Epub 2010 Feb 1. — View Citation

Guner A, Boz A, Ozkan OF, Ileli O, Kece C, Reis E. Limberg flap versus Bascom cleft lift techniques for sacrococcygeal pilonidal sinus: prospective, randomized trial. World J Surg. 2013 Sep;37(9):2074-80. doi: 10.1007/s00268-013-2111-9. — View Citation

Guner A, Ozkan OF, Kece C, Kesici S, Kucuktulu U. Modification of the Bascom cleft lift procedure for chronic pilonidal sinus: results in 141 patients. Colorectal Dis. 2013 Jul;15(7):e402-6. doi: 10.1111/codi.12243. — View Citation

Kement M, Oncel M, Kurt N, Kaptanoglu L. Sinus excision for the treatment of limited chronic pilonidal disease: results after a medium-term follow-up. Dis Colon Rectum. 2006 Nov;49(11):1758-62. — View Citation

Mentes O, Bagci M, Bilgin T, Ozgul O, Ozdemir M. Limberg flap procedure for pilonidal sinus disease: results of 353 patients. Langenbecks Arch Surg. 2008 Mar;393(2):185-9. Epub 2007 Sep 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early wound complications	Complications were classified as infection (superficial or deep), collection (seroma or hematoma), wound dehiscence (partial or complete), or anesthesia-related complications. complications will be reviewed from time of surgery to the end of healing. percentage of participants with any wound complication will be evaluated as patients with complication.	up to 3 months	No
Secondary	Assessment of recurrence (recurrence is defined when symptoms of the disease recurred after an interval following complete wound healing.)	Patients will be followed up for recurrence for three years. Total number of patients presenting with recurrence will be evaluated at the end of 3rd year.	3 years	No
Secondary	Primary healing rate	All surgical site complications were recorded, and patients with prolonged healing were regularly examined until complete healing was achieved. Primary healing was defined as no breakdown of the wound (complication-free healing) at any point along its length.	within 3 months	No
Secondary	Hospital stay "The interval from the day of surgery to the day of discharge was recorded as the ''hospital stay.''	hospital stay for patients in postoperative period will be measured from the day of surgery to the day of discharge (as days).	during first week (one week)	No
Secondary	Operative duration (''Operative duration'' is defined as the time between the initiation of the incision and the application of the last suture.)		during surgery	No