Nonoperative Treatment of Recurrent Pilonidal Sinus Disease

NCT04423510 | Completed

• 1 other identifier: KonyaTRH01
• Study Type: observational
• Target: 227
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative recurrent pilonidal sinus disease is troublesome and its treatment is challenge. Many treatment modalities have been advocated in the treatment of recurrent pilonidal sinus disease; however, there is still no consensus in the literature. Some minimally invasive techniques are used alone or as an adjunct to surgery. Crystallized phenol is the most popular method in the nonoperative treatment of primer pilonidal sinus disease. But its long term effect in the postoperative recurrent cases is unclear. Investigators aimed to present the long-term efficacy of crystallized phenol treatment on postoperative recurrent pilonidal sinus disease through our results collected within the last 20 years.

Conditions

Pilonidal Sinus

Keywords

recurrent pilonidal disease; nonoperative treatment; crystallized phenol

Outcome Measures

Primary Outcomes (1)

• Long term effect of crystallized phenol treatment in recurrent pilonidal sinus

  All participants we applied to crystallized phenol treatment (CPT) were contacted via e-mail, telephone or face-to-face interview and questioned whether there was a recurrence. The number of CPT applications and sinus characteristics (primer openings, seconder openings, sinus presentation etc.) were compared between recurrent participants and non-recurrent participants. The number of CPT application and sinus characteristic features was obtained patients files that were recorded in first consult.

  January 1995-February 2015

Secondary Outcomes (1)

• The effects of factors playing a role in the etiology of pilonidal sinus on treatment results

  January 1995-February 2016

Study Arms (1)

Recurrent pilonidal sinus

Postoperative recurrent pilonidal sinus disease

Procedure: Crystallized phenol treatment

Interventions

Crystallized phenol treatment PROCEDURE

Recurrent pilonidal sinus

Eligibility Criteria

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

Study Population

The patients who previous operated recurrent pilonidal sinus disease and who accepted crystallized phenol treatment were included in the study. Patients who at least one year of treatment and contacting later were included in our study.

You may qualify if:

• Previous operated recurrent pilonidal sinus disease
• Follow-up period of more than 12 months
• The patients who connection by e-mail or telephone

You may not qualify if:

• Primer pilonidal sinus disease
• Follow-up period of less than 12 months
• The patients who can't connection by e-mail or telephone

Sponsors & Collaborators

• Osman DOĞRU: lead

Related Publications (10)

• Lund JN, Leveson SH. Fibrin glue in the treatment of pilonidal sinus: results of a pilot study. Dis Colon Rectum. 2005 May;48(5):1094-6. doi: 10.1007/s10350-004-0905-4.

  PMID: 15868239 BACKGROUND

• Dessily M, Charara F, Ralea S, Alle JL. Pilonidal sinus destruction with a radial laser probe: technique and first Belgian experience. Acta Chir Belg. 2017 Jun;117(3):164-168. doi: 10.1080/00015458.2016.1272285. Epub 2017 Jan 6.

  PMID: 28056720 BACKGROUND

• Othman I. Skin glue improves outcome after excision and primary closure of sacrococcygeal pilonidal disease. Indian J Surg. 2010 Dec;72(6):470-4. doi: 10.1007/s12262-010-0170-9. Epub 2010 Nov 16.

  PMID: 22131657 BACKGROUND

• Stauffer VK, Luedi MM, Kauf P, Schmid M, Diekmann M, Wieferich K, Schnuriger B, Doll D. Common surgical procedures in pilonidal sinus disease: A meta-analysis, merged data analysis, and comprehensive study on recurrence. Sci Rep. 2018 Feb 15;8(1):3058. doi: 10.1038/s41598-018-20143-4.

  PMID: 29449548 RESULT

• Doll D, Luedi MM, Wysocki AP. Pilonidal sinus disease guidelines: a minefield? Tech Coloproctol. 2016 Apr;20(4):263-4. doi: 10.1007/s10151-015-1398-y. Epub 2015 Dec 17. No abstract available.

  PMID: 26681445 RESULT

• Dag A, Colak T, Turkmenoglu O, Sozutek A, Gundogdu R. Phenol procedure for pilonidal sinus disease and risk factors for treatment failure. Surgery. 2012 Jan;151(1):113-7. doi: 10.1016/j.surg.2011.07.015. Epub 2011 Oct 6.

  PMID: 21982072 RESULT

• Kaymakcioglu N, Yagci G, Simsek A, Unlu A, Tekin OF, Cetiner S, Tufan T. Treatment of pilonidal sinus by phenol application and factors affecting the recurrence. Tech Coloproctol. 2005 Apr;9(1):21-4. doi: 10.1007/s10151-005-0187-4.

  PMID: 15868494 RESULT

• Dogru O, Camci C, Aygen E, Girgin M, Topuz O. Pilonidal sinus treated with crystallized phenol: an eight-year experience. Dis Colon Rectum. 2004 Nov;47(11):1934-8. doi: 10.1007/s10350-004-0720-y.

  PMID: 15622588 RESULT

• Aygen E, Arslan K, Dogru O, Basbug M, Camci C. Crystallized phenol in nonoperative treatment of previously operated, recurrent pilonidal disease. Dis Colon Rectum. 2010 Jun;53(6):932-5. doi: 10.1007/DCR.0b013e3181d8283b.

  PMID: 20485008 RESULT

• Emiroglu M, Karaali C, Esin H, Akpinar G, Aydin C. Treatment of pilonidal disease by phenol application. Turk J Surg. 2017 Mar 1;33(1):5-9. doi: 10.5152/UCD.2016.3532. eCollection 2017.

  PMID: 28589180 RESULT

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Study Officials

• Ersin TURAN, 3

  Konya Education and Research Hospital

  STUDY CHAIR

• Ramazan Saygın KERİMOĞLU, 4

  Konya Education and Research Hospital

  STUDY CHAIR

• Emet Ebru NAZİK, 5

  Konya Education and Research Hospital

  STUDY CHAIR

• Ebru Esen, 6

  Konya Education and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: March 1, 1995
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2016
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: The data will become available starting 6 months after publication.
• Access Criteria: The data will share as SPSS dataset.