Staging System for Chronic Symptomatic Pilonidal Sinus Disease

NCT02712970 | Completed

• 1 other identifier: TrabzonNTRH
• Study Type: observational
• Target: 367
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Assessment of recurrence (recurrence is defined when symptoms of the disease recurred after an interval following complete wound healing.)

  3 years

• Primary healing rate

  within 3 months

• Hospital stay "The interval from the day of surgery to the day of discharge was recorded as the ''hospital stay.''

  during first week (one week)

• Operative duration (''Operative duration'' is defined as the time between the initiation of the incision and the application of the last suture.)

  during surgery

Study Arms (5)

stage-I

Single pit in the midline, no lateral extension. Pit-picking technique will be performed.

Procedure: pit-picking technique

Stage-II

\>1 pits in the midline, no lateral extension. Pit-picking and Bascom cleft lift techniques will be performed.

Procedure: pit-picking technique; Procedure: Bascom Cleft Lift

Stage-III

Midline pit/pits plus lateral extension in one direction. Bascom cleft lift technique will be performed.

Procedure: Bascom Cleft Lift

Stage-IV

Midline pit/pits plus lateral extension in both directions. Rhomboid excision with the Limberg Flap will be performed.

Procedure: Rhomboid excision with the Limberg Flap

Stage-R

Recurrent PSD following any type of treatment. Other flap techniques such as V-Y advancement flap, Z-Plasty will be performed.

Procedure: Bascom Cleft Lift; Procedure: Rhomboid excision with the Limberg Flap; Procedure: Other flap techniques

Interventions

pit-picking technique PROCEDURE

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.

Stage-II; stage-I

Bascom Cleft Lift PROCEDURE

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.

Stage-II; Stage-III; Stage-R

Rhomboid excision with the Limberg Flap PROCEDURE

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

Stage-IV; Stage-R

Other flap techniques PROCEDURE

Bascom Cleft lift as described above, Rhomboid excision with the Limberg Flap as described above, V-Y advancement flap, Z-Plasty

Stage-R

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that were operated because of chronic symptomatic pilonidal sinus disease

You may qualify if:

• Individuals with symptomatic pilonidal sinus disease.

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Trabzon Numune Training and Research Hospital: lead
• Karadeniz Technical University: collaborator

Related Publications (7)

• 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.

  PMID: 23732258 BACKGROUND

• 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.

  PMID: 23581906 BACKGROUND

• 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. doi: 10.1016/j.amjsurg.2007.01.008.

  PMID: 17434365 BACKGROUND

• 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. doi: 10.1007/s00423-007-0227-9. Epub 2007 Sep 22.

  PMID: 17899165 BACKGROUND

• 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.

  PMID: 20122682 BACKGROUND

• 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. doi: 10.1007/s10350-006-0676-1.

  PMID: 16990977 BACKGROUND

• Guner A, Cekic AB, Boz A, Turkyilmaz S, Kucuktulu U. A proposed staging system for chronic symptomatic pilonidal sinus disease and results in patients treated with stage-based approach. BMC Surg. 2016 Apr 16;16:18. doi: 10.1186/s12893-016-0134-5.

  PMID: 27084534 DERIVED

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 5, 2016
• First Posted: March 18, 2016
• Study Start: January 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: March 18, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share