Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease

Pilonidal Sinus Clinical Trial

— SPQF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05404243
• Other study ID #: HJ23
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: June 2022
• Source: HJ23
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: May 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Pilonidal Disease
• Pilonidal Disease of Natal Cleft
• Pilonidal Sinus

Intervention

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.

Procedure:
• Conventional surgery
In case of conventional surgery, entire exeresis is performed by means of an electric scalpel

Locations

Country	Name	City	State
Spain	Jordi Elvira Lopez	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
HJ23

Country where clinical trial is conducted

Spain, 

References & Publications (10)

Almajid FM, Alabdrabalnabi AA, Almulhim KA. The risk of recurrence of Pilonidal disease after surgical management. Saudi Med J. 2017 Jan;38(1):70-74. doi: 10.15537/smj.2017.1.15892. — View Citation

Arslan S, Okur MH, Basuguy E, Aydogdu B, Zeytun H, Cal S, Tegin S, Azizoglu M. Crystallized phenol for treatment of pilonidal sinus disease in children: a comparative clinical study. Pediatr Surg Int. 2021 Jun;37(6):807-813. doi: 10.1007/s00383-020-04798- — View Citation

Bascom J. Pilonidal disease: origin from follicles of hairs and results of follicle removal as treatment. Surgery. 1980 May;87(5):567-72. — View Citation

Corman ML. Classic articles in colonic and rectal surgery, Pilonidal Sinus. Dis Colon Rectum. 1981 May-Jun;24(4):324-6. — View Citation

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. — View Citation

GOODALL P. The aetiology and treatment of pilonidal sinus. A review of 163 patients. Br J Surg. 1961 Sep;49:212-8. — View Citation

Karydakis GE. New approach to the problem of pilonidal sinus. Lancet. 1973 Dec 22;2(7843):1414-5. — View Citation

Nordon IM, Senapati A, Cripps NP. A prospective randomized controlled trial of simple Bascom's technique versus Bascom's cleft closure for the treatment of chronic pilonidal disease. Am J Surg. 2009 Feb;197(2):189-92. doi: 10.1016/j.amjsurg.2008.01.020. Epub 2008 Jul 17. — View Citation

Søndenaa K, Andersen E, Nesvik I, Søreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. — View Citation

Yuksel ME. Pilonidal sinus disease can be treated with crystallized phenol using a simple three-step technique. Acta Dermatovenerol Alp Pannonica Adriat. 2017 Mar;26(1):15-17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence	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	sick leave	time from surgery to return to work. This will be counted in days.	up to 1 year