Nonoperative Treatment of Recurrent Pilonidal Sinus Disease

June 7, 2020 updated by: Osman DOĞRU

Previously Operated Recurrent Pilonidal Sinus Treated With Crystallized Phenol: Twenty Years Experience

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

227

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Recurrent pilonidal sinus
Postoperative recurrent pilonidal sinus disease
Procedure: Crystallized phenol treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term effect of crystallized phenol treatment in recurrent pilonidal sinus
Time Frame: January 1995-February 2015
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effects of factors playing a role in the etiology of pilonidal sinus on treatment results
Time Frame: January 1995-February 2016
All participants we applied to crystallized phenol treatment were contacted via e-mail, telephone or face-to-face interview and questioned whether there was a recurrence. The relationship between relapsed participants and non-relapsed participants was investigated between the factors accused in etiology (gender, BMI, family history, pilosity levels, skin tone etc.). Factors accused in etiology were obtained patients files that were recorded in first consult.
January 1995-February 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osman DOĞRU

Investigators

  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 1995

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 7, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 7, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KonyaTRH01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

We are planned to share that all of individual participant data.

IPD Sharing Time Frame

The data will become available starting 6 months after publication.

IPD Sharing Access Criteria

The data will share as SPSS dataset.

IPD Sharing Supporting Information Type

  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pilonidal Sinus

Clinical Trials on Crystallized phenol treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe