Nonoperative Treatment of Recurrent Pilonidal Sinus Disease

NCT ID: NCT04423510

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 227 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1995-03-01
• Study Completion Date: 2016-02-01

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.

Detailed Description

Study data were collected prospectively and analyzed retrospectively. The demographic data of the patients, other parameters such as smoking, whether they sit a lot due to occupation (sitting at work for at least 6 hours a day), skin tone (whiter, darker), presence of positive family history, BMI (kg/m2, patients were divided into BMI <30 and BMI> 30), pilosity levels (mild,moderate, severe) were also recorded. In addition, the time from the recurrence to admission, the number and type of previous operations, and the status of the sinus at presentation (acute, chronic) were recorded. The presence of purulent discharge from the sinus opening and the presence of signs of inflammation or abscess formation in this region were evaluated as acute pilonidal sinus disease (PSD). The presence of serous discharge from the sinus opening and absence of abscess formation were evaluated as chronic PSD. Investigators investigated whether the factors mentioned above affect the number of applications and recurrence after crystallized phenol treatment (CPT).

The treatment procedure was applied to all patients by one surgical team. One day before the procedure, patients were asked to clean the hair from the waist to the middle of the thighs with depilatory creams or epilation. After local anesthesia was performed around the holes, a thin mosquito clamp was inserted into the sinus and the hairs were removed and the skin around the hole was covered by nitrofurantoin pomade to prevent chemical irritation. Then crystallized phenol was introduced into the sinus with the same clamp. Patients were allowed to return to their daily activities after the procedure. This procedure was performed every 3 weeks. If there was discharge from the wound during the follow-up examination, the procedure was repeated. The closure of the sinus hole and the complete disappearance of the discharge were accepted as healing. After the treatment, follow-up was started. Follow up was done first yearly than five years intervals. All of our patients' contact information was recorded by us and we tried to reach the patients every 5 years by any means (phone or e-mail). Investigators tried to follow them up by contacting them periodically, whether they contact us or not. According to this follow-up, patients were analyzed by divided into 3 groups(1-5 years, 5-10 years, 10-20 years). Patients who could not be reached by any means of communication were included in the unreachable group. Patients were recommended to have hair removal at the wound site once a month for 6 years.

Number of crystallized phenol application, presence of recurrence and number of recurrence after CPT and follow-up data were evaluated. Recurrence of the sinus hole which was found to occur again at least 6 months after being determined to be closed was considered as recurrence. If no recurrence was observed during the follow-up or if post-CPT recurrence was healed after treatment, CPT was considered successful.

Conditions

Pilonidal Sinus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Recurrent pilonidal sinus

Postoperative recurrent pilonidal sinus disease

Crystallized phenol treatment

Intervention Type: PROCEDURE

Interventions

Crystallized phenol treatment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osman DOĞRU

OTHER

Sponsor Role: lead

Responsible Party

Osman DOĞRU

Professor, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ersin TURAN, 3

Role: STUDY_CHAIR

Konya Education and Research Hospital

Ramazan Saygın KERİMOĞLU, 4

Role: STUDY_CHAIR

Konya Education and Research Hospital

Emet Ebru NAZİK, 5

Role: STUDY_CHAIR

Konya Education and Research Hospital

Ebru Esen, 6

Role: STUDY_CHAIR

Konya Education and Research Hospital

References

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Reference Type: BACKGROUND

PMID: 15868239 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28056720 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22131657 (View on PubMed)

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Reference Type: RESULT

PMID: 29449548 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26681445 (View on PubMed)

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.

Reference Type: RESULT

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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.

Reference Type: RESULT

PMID: 15868494 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15622588 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20485008 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28589180 (View on PubMed)

Other Identifiers

KonyaTRH01

Identifier Type: -

Identifier Source: org_study_id