Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease
NCT ID: NCT05404243
Last Updated: 2022-06-07
Study Results
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Basic Information
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COMPLETED
PHASE4
122 participants
INTERVENTIONAL
2021-01-01
2022-05-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
conventional surgery
entire exeresis is performed by means of an electric scalpel
Conventional surgery
In case of conventional surgery, entire exeresis is performed by means of an electric scalpel
Interventions
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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.
Conventional surgery
In case of conventional surgery, entire exeresis is performed by means of an electric scalpel
Eligibility Criteria
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Inclusion Criteria
* 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
* complicated Sacrococcygeal pilonidal disease
* non-randomized surgical management
18 Years
65 Years
ALL
No
Sponsors
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HJ23
INDUSTRY
Responsible Party
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Jordi Elvira Lopez
Principal investigator
Locations
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Jordi Elvira Lopez
Tarragona, , Spain
Countries
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References
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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.
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.
Bascom J. Pilonidal disease: origin from follicles of hairs and results of follicle removal as treatment. Surgery. 1980 May;87(5):567-72.
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.
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.
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.
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.
Corman ML. Classic articles in colonic and rectal surgery, Pilonidal Sinus. Dis Colon Rectum. 1981 May-Jun;24(4):324-6. No abstract available.
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.
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.
Other Identifiers
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HJ23
Identifier Type: -
Identifier Source: org_study_id
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