The Use of Topical Anaesthetic in the Banding of Internal Haemorrhoids (TAB)
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|ClinicalTrials.gov Identifier: NCT04031131|
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : November 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids||Drug: Instillagel Other: KY Gel||Phase 2|
A feasibility trial assessing patient recruitment, retention, randomization, and surgeon acceptability of topical anaesthetic use during rubber band ligation of haemorrhoids.
A patient and assessor blinded feasibility trial. The trial population will prospectively be recruited from colorectal surgery outpatients. Patients will be randomized to two groups to receive: lubricating gel (K-Y Jelly) and topical anaesthetic gel (Instillagel) or lubricating gel alone (the standard care).
The intervention group will receive lubricating gel and topical anaesthetic gel (containing lidocaine active ingredient) administered rectally, whilst the control group will receive lubricating gel alone (standard care). This will be carried out in Colorectal Outpatients. The band ligation of the haemorrhoids should occur between 5-10 minutes after administration of the topical anaesthetic/lubricating gel. Pain scores and the use of oral analgesia will be measured immediately after the procedure (5 minutes), upon leaving the clinic (approximately 30 minutes after), at 4 hours, and 72 hours following the procedure. Vasovagal symptoms or other complications will be recorded whilst the patient is in the clinic. At 1 month post procedure, patients will be phoned to determine if any adverse events have occurred.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The trial will be a randomised control trial blinded to patient and assessor (the clinician collecting data at 4 hours, 72 hours and 1 month after the procedure. Randomisation will be achieved by a computer software. Administrators will be aware of which group the patient being treated is in. Half of the patients (n=30) will receive the intervention treatment (Instillagel topical anaesthetic) and lubricating gel (standard of care), the other half will receive the standard of care alone (lubricating gel) (n=30) before the procedure. The standard of care is to use no form of analgesia, with K-Y gel only being used as a lubricant. Researchers will be asked to apply the allocated treatment 5-10 minutes before the procedure. The primary end points will be: patient recruitment rate, patient acceptability, surgeon acceptability, patient retention. The secondary endpoints will be: pain scores using the 10-point visual analogue scale.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Blinded to assessors and patients|
|Official Title:||The Use of Topical Anaesthetic in the Banding (TAB) of Internal Haemorrhoids: A Feasibility Study.|
|Actual Study Start Date :||October 17, 2019|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||February 29, 2020|
Active Comparator: Intervention Arm
topical anaesthetic gel and lubricating gel
Topical Anaesthetic Gel (Instillagel) licensed for rectal administration.
Other: KY Gel
Placebo Comparator: Control Arm
lubricating gel alone
Other: KY Gel
- Patient recruitment rate [ Time Frame: 5 months ]Patient recruitment rate via screening log.
- Treatment acceptability to patients [ Time Frame: 5 months ]Treatment acceptability to patients via study questionnaire. A visual analogue scale to be used, 0 - 10 with '0' being no pain and '10' being worst pain possible.
- Patient retention [ Time Frame: 5 months ]Patient retention via recruitment log.
- Assess if the intervention reduced pain associated with haemorrhoids up to 72 hours after the procedure, [ Time Frame: 72 hours ]Assess if the intervention reduced pain associated with haemorrhoids up to 72 hours after the procedure via study questionnaire.
- Assess if the intervention reduces vasovagal symptoms up to 72 hours after the procedure [ Time Frame: 72 hours ]Assess if the intervention reduces vasovagal symptoms up to 72 hours after the procedure via study questionnaire.
- Assess if the intervention reduced oral analgesia burden following the procedure [ Time Frame: 72 hours ]Assess if the intervention reduced oral analgesia burden following the procedure via study questionnaire.
- Assess hospital readmission 1 month after the procedure. [ Time Frame: 1 month ]Assess hospital readmission 1 month after the procedure via review of hospital notes. The number of patients requiring additional analgesia will be compared between the two groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031131
|Contact: Vivek Sharma, Dr||+44 1603 email@example.com|
|Contact: James Hernon, Mr||+44 1603 firstname.lastname@example.org|
|Norfolk & Norwich University Hospitals NHS Foundation Trust||Recruiting|
|Norwich, Norfolk, United Kingdom, NR4 7UY|
|Contact: Julie Dawson, Mrs +44 1603 286611 email@example.com|
|Principal Investigator:||Vivek Sharma, Dr||Foundation Year 1 Doctor|