Sacrococcygeal FistulaPhase 4SPQFNCT05404243
Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease
A Phase 4 study testing phenolization and Conventional surgery in people with Sacrococcygeal Fistula and Pilonidal Sinus, run by HJ23 at 1 site in Spain.
Trial summary
Randomized clinical trial to test the efficacy and safety of phenolization in uncomplicated Sacrococcygeal pilonidal disease Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sacrococcygeal Fistula, Pilonidal Sinus, Pilonidal Disease
- What is being tested?
- phenolization and Conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 1 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy or breastfeeding
- complicated Sacrococcygeal pilonidal disease
- non-randomized surgical management
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial to Test the Efficacy and Safety of Phenolization in Uncomplicated Sacrococcygeal Pilonidal Disease
Randomized clinical trial to test the efficacy and safety of phenolization in uncomplicated Sacrococcygeal pilonidal disease
Read the detailed 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
- Conditions
- Sacrococcygeal Fistula, Pilonidal Sinus, Pilonidal Disease, Pilonidal Disease of Natal Cleft
- Being tested
- phenolization, Conventional surgery
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenolizationDrug
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 surgeryProcedure or surgery
In case of conventional surgery, entire exeresis is performed by means of an electric scalpel
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: phenolization |
| conventional surgery | Active comparator | entire exeresis is performed by means of an electric scalpel Receives: Procedure: Conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 year
Secondary outcomes (1)
sick leave
time from surgery to return to work. This will be counted in days.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Jan 2021
- Primary completion1 Dec 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Sacrococcygeal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical trial
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- HJ23
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jordi Elvira Lopez, HJ23
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404243
- Sponsor's protocol ID
- HJ23
- Acronym
- SPQF
- Status last verified
- Jun 2022
- First submitted
- 31 May 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only anonymized data on anthropometric characteristics, surgery characteristics, and patient outcomes will be made available.
Publications
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.
PubMed 18639221Karydakis 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.
PubMed 4128725Bascom J. Pilonidal disease: origin from follicles of hairs and results of follicle removal as treatment. Surgery. 1980 May;87(5):567-72.
PubMed 7368107Sondenaa 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.
PubMed 7745322Dag 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.
PubMed 21982072Almajid 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.
PubMed 28042633GOODALL 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.
PubMed 13900261Corman ML. Classic articles in colonic and rectal surgery, Pilonidal Sinus. Dis Colon Rectum. 1981 May-Jun;24(4):324-6. No abstract available.
PubMed 7016481Arslan 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.
PubMed 33856512Yuksel 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.
PubMed 28352930
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Test the Efficacy and Safety of Phenolization in Uncomplicated Sacrococcygeal Pilonidal Disease
- ClinicalTrials.gov ID
- NCT05404243
- Acronym / sponsor ID
- SPQF / HJ23
- Conditions
- Sacrococcygeal Fistula, Pilonidal Sinus, Pilonidal Disease, Pilonidal Disease of Natal Cleft
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- HJ23Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized clinical trial to test the efficacy and safety of phenolization in uncomplicated Sacrococcygeal pilonidal disease
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Clinical trial
| Arm | Type | Receives |
|---|---|---|
| phenolization group | Experimental | Drug: phenolizationCurettage 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. |
| conventional surgery | Active comparator | Procedure: Conventional surgeryentire exeresis is performed by means of an electric scalpel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- pregnancy or breastfeeding
- complicated Sacrococcygeal pilonidal disease
- non-randomized surgical management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phenolizationIn 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. | Drug | phenolization group |
| Conventional surgeryIn case of conventional surgery, entire exeresis is performed by means of an electric scalpel | Procedure or surgery | conventional surgery |
Primary outcome
recurrence
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
1 secondary outcome
sick leave
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Background: PubMed 18639221Nordon 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.
- Background: PubMed 4128725Karydakis 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.
- Background: PubMed 7368107Bascom J. Pilonidal disease: origin from follicles of hairs and results of follicle removal as treatment. Surgery. 1980 May;87(5):567-72.
- Background: PubMed 7745322Sondenaa 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.
- Background: PubMed 21982072Dag 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.
- Results publication: PubMed 28042633Almajid 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.
- Results publication: PubMed 13900261GOODALL 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.
- Results publication: PubMed 7016481Corman ML. Classic articles in colonic and rectal surgery, Pilonidal Sinus. Dis Colon Rectum. 1981 May-Jun;24(4):324-6. No abstract available.
- Results publication: PubMed 33856512Arslan 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.
- Results publication: PubMed 28352930Yuksel 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.
- Individual participant dataSharing planned: No. Only anonymized data on anthropometric characteristics, surgery characteristics, and patient outcomes will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing phenolization and Conventional surgery in people with Sacrococcygeal Fistula and Pilonidal Sinus, run by HJ23 at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05404243, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.