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

NCT ID: NCT05851690

Last Updated: 2023-05-10

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

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-16

Study Completion Date

2020-01-25

Brief Summary

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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.

Detailed Description

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Conditions

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Pilonidal Sinus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bilateral Parallel Elliptic Flap

Patients operated with the bilateral parallel elliptic flap technique.

Group Type ACTIVE_COMPARATOR

Surgical treatment of pilonidal sinus disease

Intervention Type PROCEDURE

Advancement flap techniques in surgical treatment of pilonidal sinus disease.

Karydakis Flap

Patients operated with the karydakis flap technique.

Group Type ACTIVE_COMPARATOR

Surgical treatment of pilonidal sinus disease

Intervention Type PROCEDURE

Advancement flap techniques in surgical treatment of pilonidal sinus disease.

Interventions

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Surgical treatment of pilonidal sinus disease

Advancement flap techniques in surgical treatment of pilonidal sinus disease.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Underwent surgery due to pilonidal sinus disease

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atlas University

OTHER

Sponsor Role lead

Responsible Party

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Umut Fırat Turan

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Bi S, Sun K, Chen S, Gu J. Surgical procedures in the pilonidal sinus disease: a systematic review and network meta-analysis. Sci Rep. 2020 Aug 13;10(1):13720. doi: 10.1038/s41598-020-70641-7.

Reference Type RESULT
PMID: 32792519 (View on PubMed)

Duman K, Girgin M, Harlak A. Prevalence of sacrococcygeal pilonidal disease in Turkey. Asian J Surg. 2017 Nov;40(6):434-437. doi: 10.1016/j.asjsur.2016.04.001. Epub 2016 May 14.

Reference Type RESULT
PMID: 27188235 (View on PubMed)

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.

Reference Type RESULT
PMID: 30640830 (View on PubMed)

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.

Reference Type RESULT
PMID: 4128725 (View on PubMed)

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.

Reference Type RESULT
PMID: 33950407 (View on PubMed)

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.

Reference Type RESULT
PMID: 23173633 (View on PubMed)

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.

Reference Type RESULT
PMID: 27451868 (View on PubMed)

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.

Reference Type RESULT
PMID: 31113167 (View on PubMed)

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.

Reference Type RESULT
PMID: 30531689 (View on PubMed)

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.

Reference Type RESULT
PMID: 28383451 (View on PubMed)

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.

Reference Type RESULT
PMID: 20091589 (View on PubMed)

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.

Reference Type RESULT
PMID: 26377583 (View on PubMed)

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.

Reference Type RESULT
PMID: 26094093 (View on PubMed)

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.

Reference Type RESULT
PMID: 26011208 (View on PubMed)

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.

Reference Type RESULT
PMID: 23430349 (View on PubMed)

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.

Reference Type RESULT
PMID: 26039952 (View on PubMed)

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.

Reference Type RESULT
PMID: 21788003 (View on PubMed)

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.

Reference Type RESULT
PMID: 31848678 (View on PubMed)

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.

Reference Type RESULT
PMID: 23478617 (View on PubMed)

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

Reference Type RESULT
PMID: 12516846 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37351640 (View on PubMed)

Other Identifiers

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E-16-975

Identifier Type: -

Identifier Source: org_study_id

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