Jordi Elvira Lopez
Tarragona, 43005, Spain
NCT Number: NCT05404243
Randomized clinical trial to test the efficacy and safety of phenolization in uncomplicated Sacrococcygeal pilonidal disease
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Tarragona, 43005, Spain
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
In case of conventional surgery, entire exeresis is performed by means of an electric scalpel
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
Time frame: up to 1 year
time from surgery to return to work. This will be counted in days.
HJ23
Industry
Randomized Clinical Trial to Test the Efficacy and Safety of Phenolization in Uncomplicated Sacrococcygeal Pilonidal Disease
Acronym: SPQF
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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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