Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000751673
Ethics application status
Approved
Date submitted
9/05/2023
Date registered
11/07/2023
Date last updated
12/07/2023
Date data sharing statement initially provided
11/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the effect of drug treatment with a needle from the coccyx in patients with chronic anal fissure
Scientific title
The Effect of Caudal Epidural Injection on Healing in the Treatment of Chronic Anal Fissure
Secondary ID [1] 309631 0
none
Universal Trial Number (UTN)
U1111-1292-3567
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic anal fissure 329960 0
Condition category
Condition code
Anaesthesiology 326866 326866 0 0
Pain management
Oral and Gastrointestinal 327096 327096 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Hundred twenty consecutive patients with the diagnosis of chronic anal fissure were enrolled this randomized, controlled study. Caudal epidural injection group (Group K, n=60) was treated with 5cc bupivacain + 5cc isotonic from a caudal epidural for a total of 3 sessions at the beginning, 1 week and 2 weeks later; The patients who were taken to the surgery room were monitored using electrocardiography, arterial pressure(noninvasive) and pulse oximetry, and baseline values were recorded. 10 ml for each patient. 0.25% Bupivacaine (Marcain, OSEL) was prepared using a syringe. A pillow was placed in the pelvic region of patients in the prone position. After the area was cleaned and covered, the sacral hiatus was determined by palpation by the anesthesiologist and a 22 G 9 cm needle was pushed forward until bone was touched at a 45° angle to the skin. Then, the angle of the needle, which was withdrawn to the skin, was decreased from 20° to 5°, and it was pushed forward 5-6 cm into the epidural distance by passing through the sacrococcygeal ligament. After observing that the blood and cerebrospinal fluid did not result in negative aspiration, the prepared bupivacaine was injected.The approximate duration of each caudal epidural injection session was 15 minutes.
The diagnosis of chronic anal fissure and the evaluation of the anal fissure during the caudal epidural injection(CEI) procedure were performed by an expert colorectal surgeon.
Intervention code [1] 326061 0
Prevention
Comparator / control treatment
In the second group, the control group (Group C, n=60) was given topical drug therapy in the form of a cream rectal containing 5% tribinoside and 2% lidocaine hydrochloride as the active ingredient.
All patients will apply the cream by the rectal route 3 times a day for 2 weeks.
All patients will be called by phone and their treatment applications will be checked.
At the end of 2 weeks, the patients were admitted to the outpatient clinic.
The diagnosis of chronic anal fissure and the evaluation of the anal fissure during the caudal epidural injection(CEI) procedure were performed by an expert colorectal surgeon.
Control group
Active

Outcomes
Primary outcome [1] 334714 0
Visual analog scale(VAS) for pain were used to assess the severity of symptoms of chronic anal fissure.
Timepoint [1] 334714 0
Baseline (pre-injection), 1 week post-baseline (pre-injection) and 2 weeks post-baseline (pre-injection)
Primary outcome [2] 334715 0
The Wexner constipation score(WCS) for constipation were used. to assess the severity of symptoms of chronic anal fissure.
Timepoint [2] 334715 0
Baseline (pre-injection), 1 week post-baseline (pre-injection) and 2 weeks post-baseline (pre-injection)
Secondary outcome [1] 421837 0
The Short Form (SF)-36 was used to determine the quality of life of the patient before and after Caudal Epidural Injection applications.
Timepoint [1] 421837 0
At the Baseline (pre-injection) and 2 weeks post-baseline (pre-injection)

Eligibility
Key inclusion criteria
Patients were included in the study if they were older than 18 years or older with chronic anal fissure for at least 6 months.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were pregnancy, diabetes mellitus, neurological diseases, spinal cord lesions, and use of cardiac pacemaker or an implantable cardiac defibrillator.
Age <18 or >70 years patients

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
30
Final
Recruitment outside Australia
Country [1] 25492 0
Turkey
State/province [1] 25492 0
DIYARBAKIR

Funding & Sponsors
Funding source category [1] 313815 0
Hospital
Name [1] 313815 0
Health Sciences University Diyarbakir Gazi Yasargil Research and Education Hospital, Diyarbakir, Turkey
Country [1] 313815 0
Turkey
Primary sponsor type
Individual
Name
ERHAN GÖKÇEK
Address
Talaytepe, Üçkuyular Mahallesi Elazig Yolu, Üzeri 10.Km, 21010 Kayapinar/Diyarbakir
Country
Turkey
Secondary sponsor category [1] 315652 0
None
Name [1] 315652 0
Address [1] 315652 0
Country [1] 315652 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312975 0
Health Sciences University Diyarbakir Gazi Yasargil Research and Education Hospital, Diyarbakir, Turkey
Ethics committee address [1] 312975 0
Talaytepe, Üçkuyular Mahallesi Elazig Yolu, Üzeri 10.Km, 21010 Kayapinar/Diyarbakir
Ethics committee country [1] 312975 0
Turkey
Date submitted for ethics approval [1] 312975 0
Approval date [1] 312975 0
21/04/2022
Ethics approval number [1] 312975 0

Summary
Brief summary
The primary aim of this study was to test the hypothesis that caudal epidural injection provides a more effective improvement to medical treatment in patients with chronic anal fissure.
In addition, the secondary aim of our study was to show that caudal epidural injection provides a significant improvement in the quality of life of patients with chronic anal fissures because they have less constipation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126550 0
A/Prof Erhan Gökçek
Address 126550 0
Diyarbakir Gazi Yasargil Training and Education Hospital
Talaytepe, Üçkuyular Mahallesi Elazig Yolu, Üzeri 10.Km, 21010 Kayapinar/Diyarbakir
Country 126550 0
Turkey
Phone 126550 0
+904122580060
Fax 126550 0
Email 126550 0
gokcekerhan_44@hotmail.com
Contact person for public queries
Name 126551 0
A/Prof Erhan Gökçek
Address 126551 0
Diyarbakir Gazi Yasargil Training and Education Hospital
Talaytepe, Üçkuyular Mahallesi Elazig Yolu, Üzeri 10.Km, 21010 Kayapinar/Diyarbakir
Country 126551 0
Turkey
Phone 126551 0
+904122580060
Fax 126551 0
Email 126551 0
gokcekerhan_44@hotmail.com
Contact person for scientific queries
Name 126552 0
A/Prof Erhan Gökçek
Address 126552 0
Diyarbakir Gazi Yasargil Training and Education Hospital
Talaytepe, Üçkuyular Mahallesi Elazig Yolu, Üzeri 10.Km, 21010 Kayapinar/Diyarbakir
Country 126552 0
Turkey
Phone 126552 0
+904122580060
Fax 126552 0
Email 126552 0
gokcekerhan_44@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
after de-identification; individual participant data underlying published results only.
When will data be available (start and end dates)?
available for 5 years after publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
gokcekerhan_44@hotmail.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.