Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease

NCT05404243 | Completed Phase 4 DMC

• 1 other identifier: HJ23
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sacrococcygeal Fistula; Pilonidal Sinus; Pilonidal Disease; Pilonidal Disease of Natal Cleft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• sick leave

  up to 1 year

Study Arms (2)

phenolization group

EXPERIMENTAL

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

conventional surgery

ACTIVE COMPARATOR

entire exeresis is performed by means of an electric scalpel

Procedure: Conventional surgery

Interventions

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.

phenolization group

Conventional surgery PROCEDURE

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

conventional surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• HJ23: lead

Study Sites (1)

Jordi Elvira Lopez

Tarragona, 43005, Spain

Location

Related Publications (10)

• 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.

  PMID: 18639221 BACKGROUND

• Karydakis GE. New approach to the problem of pilonidal sinus. Lancet. 1973 Dec 22;2(7843):1414-5. doi: 10.1016/s0140-6736(73)92803-1. No abstract available.

  PMID: 4128725 BACKGROUND

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

  PMID: 7368107 BACKGROUND

• Sondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. doi: 10.1007/BF00337585.

  PMID: 7745322 BACKGROUND

• 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.

  PMID: 21982072 BACKGROUND

• 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.

  PMID: 28042633 RESULT

• GOODALL P. The aetiology and treatment of pilonidal sinus. A review of 163 patients. Br J Surg. 1961 Sep;49:212-8. doi: 10.1002/bjs.18004921421. No abstract available.

  PMID: 13900261 RESULT

• Corman ML. Classic articles in colonic and rectal surgery, Pilonidal Sinus. Dis Colon Rectum. 1981 May-Jun;24(4):324-6. No abstract available.

  PMID: 7016481 RESULT

• 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/s00383-020-04798-7. Epub 2021 Apr 15.

  PMID: 33856512 RESULT

• 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. doi: 10.15570/actaapa.2017.4.

  PMID: 28352930 RESULT

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized Clinical trial

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 3, 2022
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: May 1, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)