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Completed

NCT Number: NCT05404243

Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jordi Elvira Lopez

Tarragona, 43005, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phenolization

Drug

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.

conventional surgery

Procedure

In case of conventional surgery, entire exeresis is performed by means of an electric scalpel

Primary outcomes

  1. 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

Secondary outcomes

  1. sick leave

    Time frame: up to 1 year

    time from surgery to return to work. This will be counted in days.

Sponsors and collaborators

Lead sponsor

HJ23

Industry

Registry information

Official study title

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

Acronym: SPQF

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jun 3, 2022
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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