The Use of Topical Anaesthetic in the Banding of Internal Haemorrhoids (TAB)

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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhoids
• Intervention / Treatment: Drug: Instillagel; Other: KY Gel

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Norfolk & Norwich University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Julie Dawson
• Investigators: Principal Investigator: Vivek Sharma, Dr, Foundation Year 1 Doctor

Publications and helpful links

General Publications

• Watson NF, Liptrott S, Maxwell-Armstrong CA. A prospective audit of early pain and patient satisfaction following out-patient band ligation of haemorrhoids. Ann R Coll Surg Engl. 2006 May;88(3):275-9. doi: 10.1308/003588406X98649.
• Gokalp A, Baskonus I, Maralcan G. A prospective randomised study of local anaesthetic injection after multiple rubber band ligation of haemorrhoids. Chir Ital. 2003 Mar-Apr;55(2):213-7.
• Kwok HC, Noblett SE, Murray NE, Merrie AE, Hayes JL, Bissett IP. The use of local anaesthesia in haemorrhoidal banding: a randomized controlled trial. Colorectal Dis. 2013 Apr;15(4):487-91. doi: 10.1111/codi.12088.
• Law WL, Chu KW. Triple rubber band ligation for hemorrhoids: prospective, randomized trial of use of local anesthetic injection. Dis Colon Rectum. 1999 Mar;42(3):363-6. doi: 10.1007/BF02236354.
• Hooker GD, Plewes EA, Rajgopal C, Taylor BM. Local injection of bupivacaine after rubber band ligation of hemorrhoids: prospective, randomized study. Dis Colon Rectum. 1999 Feb;42(2):174-9. doi: 10.1007/BF02237123.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Haemorrhoid; Banding; Topical Anaesthetic
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: 258546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No