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Topical Analgesia Post-Haemorrhoidectomy

NCT04276298 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2022-05-18

No results posted yet for this study

Summary

Symptomatic haemorrhoids, or piles, have significant effects on quality of life. The treatment for advanced disease is surgical excision (haemorrhoidectomy) which is extremely effective. However, pain following haemorrhoidectomy is known by all to be a miserable experience and current treatment is not very effective. We have formulated a new cream treatment which targets three theorised mechanisms of pain after haemorrhoidectomy. We will test the effectiveness of the treatments with a multi-centred randomised controlled factorial trial with four parallel double-blinded arms containing different combinations of the active agents. The outcomes include pain scores, amount of analgesia required and time to return to work. The results of our study could provide evidence of an effective treatment for post haemorrhoidectomy pain. The treatment may provide considerable benefit to patients undergoing this surgical procedure.

Conditions

Interventions

DRUG

Metronidazole cream

10% metronidazole applied rectally

DRUG

Metronidazole and Diltiazem cream

Combination Metronidazole and Diltiazem applied rectally

DRUG

Metronidazole and Lidocaine cream

Combination metronidazole and lignocaine applied rectally

DRUG

Metronidazole, Diltiazem and Lidocaine cream

Combination of all active agents tested applied rectally

Sponsors & Collaborators

  • University of Auckland, New Zealand

    lead OTHER

Principal Investigators

  • Andrew G Hill, MBChB, MD, EdD, FRACS, FACS · Counties Manukau Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-02-01
Completion
2022-02-01

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04276298 on ClinicalTrials.gov