AzTrials
AzTrials

Pilonidal SinusNCT05851690

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

A study testing Surgical treatment of pilonidal sinus disease in people with Pilonidal Sinus, run by Atlas University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Pilonidal Sinus
What is being tested?
Surgical treatment of pilonidal sinus disease
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
No sites listed yet
Study dates
16 Jun 2016to 25 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Underwent surgery due to pilonidal sinus disease

Who cannot join

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

About this study

Official title: Bilaterally Parallel Elliptic Flap Versus Karydakis Flap in Pilonidal Sinus Disease: A Randomized Controlled Trial

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
Being tested
Surgical treatment of pilonidal sinus disease
Keywords
Pilonidal sinus disease, Flap, Karydakis, Bilaterally parallel elliptic
Medical subject headings
Pilonidal Sinus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgical treatment of pilonidal sinus diseaseProcedure or surgery

    Advancement flap techniques in surgical treatment of pilonidal sinus disease.

Study groups in NCT05851690
Study groupRoleWhat they receive
Bilateral Parallel Elliptic FlapActive comparatorPatients operated with the bilateral parallel elliptic flap technique.
Receives: Procedure: Surgical treatment of pilonidal sinus disease
Karydakis FlapActive comparatorPatients operated with the karydakis flap technique.
Receives: Procedure: Surgical treatment of pilonidal sinus disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time taken to return to work/school

    Time to return to work in daily life after surgery

    Measured: 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.

    Measured: 1 day

Secondary outcomes (2)

  1. Length of hospital stay

    Time to discharge from hospital after surgery

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

  2. Recurrence of the disease

    Recurrence of the disease

    Measured: 43 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2023
  2. Study start16 Jun 2016
  3. Primary completion18 Jan 2017
  4. Study completion25 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05851690
Sponsor's protocol ID
E-16-975
Status last verified
Apr 2023
First submitted
30 Apr 2023
Last updated
10 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication

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

Questions about this trial

What is this clinical trial studying?

A study testing Surgical treatment of pilonidal sinus disease in people with Pilonidal Sinus, run by Atlas University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time taken to return to work/school (time frame: The patients' return to work ranged from 11 to 49 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05851690, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in