Comparison of Two Different Flap Methods in the Treatment of Pilonidal Sinus Disease

NCT05851690 | Completed

• 1 other identifier: E-16-975
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sacrococcygeal pilonidal sinus disease (PSD) has been defined as a disease characterized by chronic inflammation and recurrent infections caused by the movement of hair toward the gluteal sulcus. This condition is especially seen in young men and negatively affects the quality of life of patients and prevents them from performing their work and school activities. The treatment options for PSD range from the use of antibiotics alone to reconstructed excision with tissue flaps. Although the optimal surgical treatment option remains controversial, expectations from the ideal surgical treatment include low recurrence and postoperative complication rates, early wound healing, short hospital stay, early return to work, and good cosmetic outcomes. The aim of this study was to compare the efficacy of the different flap techniques in the surgical treatment of PSD and evaluate the long-term outcomes of patients.

Conditions

Pilonidal Sinus

Keywords

Pilonidal sinus disease; Flap; Karydakis; Bilaterally parallel elliptic

Outcome Measures

Primary Outcomes (2)

• Time taken to return to work/school

  Time to return to work in daily life after surgery

  The patients' return to work ranged from 11 to 49 days.

• Postoperative pain

  The pain scores of the patients were determined on the first postoperative day. The Visual Analog Scale (VAS), scored from 1 to 10, was administered to the patients to evaluate their postoperative pain levels.

  1 day

Secondary Outcomes (2)

• Length of hospital stay

  The patients' length of hospital stay ranged from 1 to 4 days.

• Recurrence of the disease

  43 months

Study Arms (2)

Bilateral Parallel Elliptic Flap

ACTIVE COMPARATOR

Patients operated with the bilateral parallel elliptic flap technique.

Procedure: Surgical treatment of pilonidal sinus disease

Karydakis Flap

ACTIVE COMPARATOR

Patients operated with the karydakis flap technique.

Procedure: Surgical treatment of pilonidal sinus disease

Interventions

Surgical treatment of pilonidal sinus disease PROCEDURE

Advancement flap techniques in surgical treatment of pilonidal sinus disease.

Bilateral Parallel Elliptic Flap; Karydakis Flap

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Underwent surgery due to pilonidal sinus disease

You may not qualify if:

• Patients with a history of previous pilonidal sinus surgery,
• An acute pilonidal abscess,
• immunodeficiency,
• using immunosuppressive drugs,
• refuse to participate in the study

Sponsors & Collaborators

• Atlas University: lead

Related Publications (21)

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  PMID: 32792519 RESULT

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  PMID: 27188235 RESULT

• Johnson EK, Vogel JD, Cowan ML, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons' Clinical Practice Guidelines for the Management of Pilonidal Disease. Dis Colon Rectum. 2019 Feb;62(2):146-157. doi: 10.1097/DCR.0000000000001237. No abstract available.

  PMID: 30640830 RESULT

• Karydakis GE. New approach to the problem of pilonidal sinus. Lancet. 1973 Dec 22;2(7843):1414-5. doi: 10.1016/s0140-6736(73)92803-1. No abstract available.

  PMID: 4128725 RESULT

• Iesalnieks I, Ommer A, Herold A, Doll D. German National Guideline on the management of pilonidal disease: update 2020. Langenbecks Arch Surg. 2021 Dec;406(8):2569-2580. doi: 10.1007/s00423-020-02060-1. Epub 2021 May 5.

  PMID: 33950407 RESULT

• Yuksel BC, Berkem H, Ozel H, Hengirmen S. A new surgical method of pilonidal sinus treatment: a bilaterally paralel elliptic fascio-cutaneous advancement flap technique. Bratisl Lek Listy. 2012;113(12):728-31. doi: 10.4149/bll_2012_165.

  PMID: 23173633 RESULT

• Keshvari A, Keramati MR, Fazeli MS, Kazemeini A, Nouritaromlou MK. Risk factors for complications and recurrence after the Karydakis flap. J Surg Res. 2016 Jul;204(1):55-60. doi: 10.1016/j.jss.2016.04.035. Epub 2016 Apr 23.

  PMID: 27451868 RESULT

• Alvandipour M, Zamani MS, Ghorbani M, Charati JY, Karami MY. Comparison of Limberg Flap and Karydakis Flap Surgery for the Treatment of Patients With Pilonidal Sinus Disease: A Single-Blinded Parallel Randomized Study. Ann Coloproctol. 2019 Dec 31;35(6):313-318. doi: 10.3393/ac.2018.09.27. Epub 2019 May 22.

  PMID: 31113167 RESULT

• Erkent M, Sahiner IT, Bala M, Kendirci M, Yildirim MB, Topcu R, Bostanoglu S, Dolapci M. Comparison of Primary Midline Closure, Limberg Flap, and Karydakis Flap Techniques in Pilonidal Sinus Surgery. Med Sci Monit. 2018 Dec 11;24:8959-8963. doi: 10.12659/MSM.913248.

  PMID: 30531689 RESULT

• Sewefy AM, Hassanen A, Atyia AM, Saleh SK. Karydakis Flap With Compressing Tie-over Interrupted Sutures Without Drain versus Standard Karydakis for Treatment of Sacrococcygeal Pilonidal Sinus Disease. Dis Colon Rectum. 2017 May;60(5):514-520. doi: 10.1097/DCR.0000000000000784.

  PMID: 28383451 RESULT

• Al-Khamis A, McCallum I, King PM, Bruce J. Healing by primary versus secondary intention after surgical treatment for pilonidal sinus. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD006213. doi: 10.1002/14651858.CD006213.pub3.

  PMID: 20091589 RESULT

• Segre D, Pozzo M, Perinotti R, Roche B; Italian Society of Colorectal Surgery. The treatment of pilonidal disease: guidelines of the Italian Society of Colorectal Surgery (SICCR). Tech Coloproctol. 2015 Oct;19(10):607-13. doi: 10.1007/s10151-015-1369-3. Epub 2015 Sep 16.

  PMID: 26377583 RESULT

• Keshvari A, Keramati MR, Fazeli MS, Kazemeini A, Meysamie A, Nouritaromlou MK. Karydakis flap versus excision-only technique in pilonidal disease. J Surg Res. 2015 Sep;198(1):260-6. doi: 10.1016/j.jss.2015.05.039. Epub 2015 May 28.

  PMID: 26094093 RESULT

• Tokac M, Dumlu EG, Aydin MS, Yalcin A, Kilic M. Comparison of modified Limberg flap and Karydakis flap operations in pilonidal sinus surgery: prospective randomized study. Int Surg. 2015 May;100(5):870-7. doi: 10.9738/INTSURG-D-14-00213.1.

  PMID: 26011208 RESULT

• Arslan K, Said Kokcam S, Koksal H, Turan E, Atay A, Dogru O. Which flap method should be preferred for the treatment of pilonidal sinus? A prospective randomized study. Tech Coloproctol. 2014 Jan;18(1):29-37. doi: 10.1007/s10151-013-0982-2. Epub 2013 Feb 21.

  PMID: 23430349 RESULT

• Bali I, Aziret M, Sozen S, Emir S, Erdem H, Cetinkunar S, Irkorucu O. Effectiveness of Limberg and Karydakis flap in recurrent pilonidal sinus disease. Clinics (Sao Paulo). 2015 May;70(5):350-5. doi: 10.6061/clinics/2015(05)08. Epub 2015 May 1.

  PMID: 26039952 RESULT

• Ates M, Dirican A, Sarac M, Aslan A, Colak C. Short and long-term results of the Karydakis flap versus the Limberg flap for treating pilonidal sinus disease: a prospective randomized study. Am J Surg. 2011 Nov;202(5):568-73. doi: 10.1016/j.amjsurg.2010.10.021. Epub 2011 Jul 23.

  PMID: 21788003 RESULT

• Caliskan M, Kosmaz K, Subasi IE, Acar A, Evren I, Bas G, Atayoglu AT. Comparison of Common Surgical Procedures in Non-complicated Pilonidal Sinus Disease, a 7-Year Follow-Up Trial. World J Surg. 2020 Apr;44(4):1091-1098. doi: 10.1007/s00268-019-05331-1.

  PMID: 31848678 RESULT

• Bessa SS. Comparison of short-term results between the modified Karydakis flap and the modified Limberg flap in the management of pilonidal sinus disease: a randomized controlled study. Dis Colon Rectum. 2013 Apr;56(4):491-8. doi: 10.1097/DCR.0b013e31828006f7.

  PMID: 23478617 RESULT

• Hull TL, Wu J. Pilonidal disease. Surg Clin North Am. 2002 Dec;82(6):1169-85. doi: 10.1016/s0039-6109(02)00062-2.

  PMID: 12516846 RESULT

• Turan UF, Coban S, Akin T, Berkem H, Yuksel BC, Er S. Bilaterally parallel elliptic flap versus Karydakis flap in primary pilonidal sinus disease: a randomized controlled trial. Int J Colorectal Dis. 2023 Jun 23;38(1):176. doi: 10.1007/s00384-023-04475-w.

  PMID: 37351640 DERIVED

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: April 30, 2023
• First Posted: May 10, 2023
• Study Start: June 16, 2016
• Primary Completion: January 18, 2017
• Study Completion: January 25, 2020
• Last Updated: May 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: One year from the date of publication.