Clinical trial · Interventional
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
NCT05404243CI-TRIAL-00058950SPQFcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Randomized clinical trial to test the efficacy and safety of phenolization in uncomplicated Sacrococcygeal pilonidal disease
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pilonidal Disease | — | UNRESOLVED | — |
| Pilonidal Disease of Natal Cleft | — | UNRESOLVED | — |
| Pilonidal Sinus | — | UNRESOLVED | — |
| Sacrococcygeal Fistula | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional surgery | Procedure | — | UNRESOLVED |
| phenolization | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- phenolization group
- description
- 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.
- interventionNames
- Drug: phenolization
- type
- ACTIVE_COMPARATOR
- label
- conventional surgery
- description
- entire exeresis is performed by means of an electric scalpel
- interventionNames
- Procedure: Conventional surgery
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDNordon 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
- BACKGROUNDKarydakis 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
- BACKGROUNDBascom J. Pilonidal disease: origin from follicles of hairs and results of follicle removal as treatment. Surgery. 1980 May;87(5):567-72. PMID 7368107
- BACKGROUNDSondenaa 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
- BACKGROUNDDag 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
- RESULTAlmajid 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
- RESULTGOODALL 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
- RESULTCorman ML. Classic articles in colonic and rectal surgery, Pilonidal Sinus. Dis Colon Rectum. 1981 May-Jun;24(4):324-6. No abstract available.