ClinicalTrials.gg
CompletedNCT05851690Updated May 10, 2023

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

An interventional study of Surgical treatment of pilonidal sinus disease in Pilonidal Sinus, sponsored by Atlas University. Completed. Per ClinicalTrials.gov, last updated 2023-05-10.

Sponsored by Atlas University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 10 months after the study started (first participant enrolled Jun 2016, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Pilonidal Sinus

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Keywords

  • Pilonidal sinus disease
  • Flap
  • Karydakis
  • Bilaterally parallel elliptic
03

In context

Pilonidal Sinus

109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.

This study's enrollment of 102 is above the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.

Browse Pilonidal Sinus studies →

Lead sponsor

Atlas University is the lead sponsor of 96 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Underwent surgery due to pilonidal sinus disease

Exclusion criteria

Exclusion Criteria:

  • Patients with a history of previous pilonidal sinus surgery,
  • An acute pilonidal abscess,
  • immunodeficiency,
  • using drugs,
  • refuse to participate in the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Active comparator
    Bilateral Parallel Elliptic Flap

    Patients operated with the bilateral parallel elliptic flap technique.

    Procedure: Surgical treatment of pilonidal sinus disease

  • Active comparator
    Karydakis Flap

    Patients operated with the karydakis flap technique.

    Procedure: Surgical treatment of pilonidal sinus disease

Interventions

  • ProcedureSurgical treatment of pilonidal sinus disease

    Advancement flap techniques in surgical treatment of pilonidal sinus disease.

06

What researchers measure

Primary outcomes

  1. Time taken to return to work/school

    Time to return to work in daily life after surgery

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

  2. 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.

    Time frame: 1 day

Secondary outcomes

  1. Length of hospital stay

    Time to discharge from hospital after surgery

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

  2. Recurrence of the disease

    Recurrence of the disease

    Time frame: 43 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 32792519 ↗
  • 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. PubMed 27188235 ↗
  • 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. PubMed 30640830 ↗
  • 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. PubMed 4128725 ↗
  • 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. PubMed 33950407 ↗
  • 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. PubMed 23173633 ↗
  • 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. PubMed 27451868 ↗
  • 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. PubMed 31113167 ↗
  • 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. PubMed 30531689 ↗
  • 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. PubMed 28383451 ↗
  • 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. PubMed 20091589 ↗
  • 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. PubMed 26377583 ↗
  • 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. PubMed 26094093 ↗
  • 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. PubMed 26011208 ↗
  • 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. PubMed 23430349 ↗
  • 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. PubMed 26039952 ↗
  • 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. PubMed 21788003 ↗
  • 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. PubMed 31848678 ↗
  • 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. PubMed 23478617 ↗
  • Hull TL, Wu J. Pilonidal disease. Surg Clin North Am. 2002 Dec;82(6):1169-85. doi: 10.1016/s0039-6109(02)00062-2. PubMed 12516846 ↗

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication

Supporting information: Study protocol, Clinical study report

Time frame: One year from the date of publication.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2016 to primary completion in Jan 2017, 7 months.

Of 35 interventional studies with no phase under Pilonidal Sinus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2023
First posted
May 10, 2023
StartActual
Jun 16, 2016
Primary completionActual
Jan 18, 2017
CompletionActual
Jan 25, 2020
Last update
May 10, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05851690
Lead sponsor
Atlas University
Responsible party
Umut Fırat Turan (Asst. Prof., Atlas University) — Principal investigator
First posted
May 10, 2023
Start date
Jun 16, 2016
Primary completion
Jan 18, 2017
Completion
Jan 25, 2020
Last update
May 10, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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