The Use of Topical Anaesthetic in the Banding of Internal Haemorrhoids

Study Overview
=================
Brief Summary
-----------------
The investigators' aim is to assess if they can complete a study measuring the effect of local anaesthetic gel (Instillagel) on reducing pain experienced by patients undergoing a common treatment for haemorrhoids (piles). This treatment is called rubber band ligation and is commonly performed in the investigators'clinics.

Detailed Description
-----------------
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.

Official Title
-----------------
The Use of Topical Anaesthetic in the Banding (TAB) of Internal Haemorrhoids: A Feasibility Study.

Conditions
-----------------
Hemorrhoids

Intervention / Treatment
-----------------
* Drug: Instillagel
* Other: KY Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic grade 1-3 haemorrhoid disease, 18+ years old, English is the first language. Exclusion Criteria: Allergy to active ingredients of Instillagel, Allergy to local anaesthetic, Chronic liver disease, Grade 4 haemorrhoid disease, Pregnancy, Inflammatory bowel disease, Pre-existing anorectal disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Arm<br>topical anaesthetic gel and lubricating gel | Drug: Instillagel<br>* Topical Anaesthetic Gel (Instillagel) licensed for rectal administration.<br>Other: KY Gel<br>* Lubricant Gel<br>|
| Placebo Comparator: Control Arm<br>lubricating gel alone | Other: KY Gel<br>* Lubricant Gel<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient recruitment rate | Patient recruitment rate via screening log. | 5 months | 
| Treatment acceptability to patients | 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. | 5 months | 
| Patient retention | Patient retention via recruitment log. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess if the intervention reduced pain associated with haemorrhoids up to 72 hours after the procedure, | Assess if the intervention reduced pain associated with haemorrhoids up to 72 hours after the procedure via study questionnaire. | 72 hours | 
| Assess if the intervention reduces vasovagal symptoms up to 72 hours after the procedure | Assess if the intervention reduces vasovagal symptoms up to 72 hours after the procedure via study questionnaire. | 72 hours | 
| Assess if the intervention reduced oral analgesia burden following the procedure | Assess if the intervention reduced oral analgesia burden following the procedure via study questionnaire. | 72 hours | 
| Assess hospital readmission 1 month after the procedure. | 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. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Haemorrhoid, Banding, Topical Anaesthetic