HemorrhoidsPhase 2TABNCT04031131
The Use of Topical Anaesthetic in the Banding of Internal Haemorrhoids
A Phase 2 study testing Instillagel and KY Gel in people with Hemorrhoids, run by Julie Dawson at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Instillagel and KY Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Oct 2019to 1 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Symptomatic grade 1-3 haemorrhoid disease, 18+ years old, English is the first language.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemorrhoids
- Being tested
- Instillagel, KY Gel
- Keywords
- Haemorrhoid, Banding, Topical Anaesthetic
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InstillagelDrug
Topical Anaesthetic Gel (Instillagel) licensed for rectal administration.
KY GelOther
Lubricant Gel
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Active comparator | topical anaesthetic gel and lubricating gel Receives: Drug: Instillagel; Other: KY Gel |
| Control Arm | Placebo comparator | lubricating gel alone Receives: Other: KY Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient recruitment rate
Patient recruitment rate via screening log.
Measured: 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.
Measured: 5 months
Patient retention
Patient retention via recruitment log.
Measured: 5 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start17 Oct 2019
- Primary completion31 Jan 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Dawson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust
- Investigators
- Vivek Sharma, Dr, Principal investigator, Foundation Year 1 Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031131
- Sponsor's protocol ID
- 258546
- Acronym
- TAB
- Status last verified
- Oct 2020
- First submitted
- 8 Jul 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16719998Gokalp 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.
PubMed 12744096Kwok 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.
PubMed 23323626Law 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.
PubMed 10223757Hooker 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.
PubMed 10211492
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Topical Anaesthetic in the Banding (TAB) of Internal Haemorrhoids: A Feasibility Study.
- ClinicalTrials.gov ID
- NCT04031131
- Acronym / sponsor ID
- TAB / 258546
- Conditions
- Hemorrhoids
- Keywords
- Haemorrhoid, Banding, Topical Anaesthetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Julie DawsonUniversity, hospital or other
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Drug: Instillagel, Other: KY Geltopical anaesthetic gel and lubricating gel |
| Control Arm | Placebo comparator | Other: KY Gellubricating gel alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic grade 1-3 haemorrhoid disease, 18+ years old, English is the first language.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InstillagelTopical Anaesthetic Gel (Instillagel) licensed for rectal administration. | Drug | Intervention Arm |
| KY GelLubricant Gel | Other | Control Arm, Intervention Arm |
Primary outcome
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.
4 secondary outcomes
Assess if the intervention reduced pain associated with haemorrhoids 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
Time frame: 72 hours
Assess if the intervention reduced oral analgesia burden following the procedure
Time frame: 72 hours
Assess hospital readmission 1 month after the procedure.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 16719998Watson 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.
- Background: PubMed 12744096Gokalp 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.
- Background: PubMed 23323626Kwok 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.
- Background: PubMed 10223757Law 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.
- Background: PubMed 10211492Hooker 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.
- Individual participant dataSharing planned: No
Related trials for Hemorrhoids
Not yet recruiting
Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome
Internal Haemorrhoids
Enrolling by invitation
Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Not yet recruitingObservational study
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Hemorrhoid, Hemorrhoid Bleeding
Recruiting
Ligasure Versus Conventional Diathermy in Hemorrhoidectomy
Hemorrhoids
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Sharma, Dr principal investigator
Foundation Year 1 Doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Instillagel and KY Gel in people with Hemorrhoids, run by Julie Dawson at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient recruitment rate (time frame: 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04031131, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.