Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease (SPQF)

June 3, 2022 updated by: Jordi Elvira Lopez, HJ23

Randomized Clinical Trial to Test the Efficacy and Safety of Phenolization in Uncomplicated Sacrococcygeal Pilonidal Disease

Randomized clinical trial to test the efficacy and safety of phenolization in uncomplicated Sacrococcygeal pilonidal disease

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single center randomized controlled clinical trial consisting in 2 treatment groups.

All patients admitted at University Hospital of Tarragona Joan XXIII with Sacrococcygeal pilonidal disease were likely to enter in the study. All patients with uncomplicated sacrococcygeal disease, localized in the midline and with only 1 fistulous orifice.

When the patients met the criteria and after consenting the admission in the study, they were included and were operated. The patients were randomly assigned to the phenolization group or conventional-surgery group. A unique anesthetic and surgical protocol were established for both groups.

Patients in the phenolization group underwent curettage with an otorhinolaryngology spatula and endocavitary phenol with an abocath needle until complete coagulation of the cyst. Patients in the conventional-surgery group were referred to conventional surgery consisting of complete excision of the cyst and closure by second intention. Both groups were managed without admission and discharged within a few hours if they met ALDRETE criteria. They were followed daily by the home hospitalization team

The main endpoint was short or medium-term recurrence of sacrococcygeal disease. The number of recurrences per group and the time from surgery to recurrence were assessed. Secondary endpoints included degree of satisfaction and sick leave

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Tarragona, Spain, 43005
        • Jordi Elvira Lopez

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients over 18 years old
  • ASA (american society anesthesiologists) less than or equal to 3
  • patients who live accompanied in a home at a maximum distance of 30 minutes from the hospital
  • adequate cognitive capacity

Exclusion Criteria:

  • pregnancy or breastfeeding
  • complicated Sacrococcygeal pilonidal disease
  • non-randomized surgical management

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: phenolization group
Curettage of the sacral cyst is performed using a disposable otorhinolaryngologists curette. The perimeter of the cyst is covered with petroleum jelly to protect the skin, and an Abbocath catheter 18 G is introduced into the cystic cavity. Undiluted 88% phenol is instilled into the cavity, ensuring that the cystic cavity is filled. It is maintained for 5 min until complete coagulation of the cyst is achieved.
Drug: phenolization
In case of phenolization group, an Abbocath catheter 18 G is introduced into the cystic cavity. Undiluted 88% phenol is instilled into the cavity, ensuring that the cystic cavity is filled. It is maintained for 5 min until complete coagulation of the cyst is achieved.
ACTIVE_COMPARATOR: conventional surgery
entire exeresis is performed by means of an electric scalpel
Procedure: Conventional surgery
In case of conventional surgery, entire exeresis is performed by means of an electric scalpel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence
Time Frame: up to 1 year
short or medium-term recurrence of sacrococcygeal disease. For this purpose, a clinical follow-up was performed in outpatient clinics where the patient was assessed and explored regularly for signs of recurrence. The number of recurrences per group and the time from surgery to recurrence were assessed
up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sick leave
Time Frame: up to 1 year
time from surgery to return to work. This will be counted in days.
up to 1 year

Collaborators and Investigators

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

Sponsor

HJ23

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)

January 1, 2021

Primary Completion (ACTUAL)

December 1, 2021

Study Completion (ACTUAL)

May 1, 2022

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (ACTUAL)

June 3, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HJ23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only anonymized data on anthropometric characteristics, surgery characteristics, and patient outcomes will be made available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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