Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04031131
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Hemorrhoids Drug: Instillagel Other: KY Gel Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

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




Primary Outcome Measures :
  1. Patient recruitment rate [ Time Frame: 5 months ]
    Patient recruitment rate via screening log.

  2. 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.

  3. Patient retention [ Time Frame: 5 months ]
    Patient retention via recruitment log.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Vivek Sharma, Dr +44 1603 287372 vivek.sharma@nnuh.nhs.uk
Contact: James Hernon, Mr +44 1603 287372 james.hernon@nnuh.nhs.uk

Locations
Layout table for location information
United Kingdom
Norfolk & Norwich University Hospitals NHS Foundation Trust Recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Contact: Julie Dawson, Mrs    +44 1603 286611    julie.dawson@nnuh.nhs.uk   
Sponsors and Collaborators
Julie Dawson
Investigators
Layout table for investigator information
Principal Investigator: Vivek Sharma, Dr Foundation Year 1 Doctor

Publications:
Layout table for additonal information
Responsible Party: Julie Dawson, Research Services Manager, Norfolk and Norwich University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04031131    
Other Study ID Numbers: 258546
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust:
Haemorrhoid
Banding
Topical Anaesthetic
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents