ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000735156

Ethics application status

Approved

Date submitted

9/05/2019

Date registered

16/05/2019

Date last updated

16/05/2019

Date data sharing statement initially provided

16/05/2019

Date results provided

16/05/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Post-haemorrhoidectomy Pain and Metronidazole Trial

Scientific title

Efficacy of oral metronidazole for patients with post-haemorrhoidectomy pain: a double-blinded, randomised controlled trial

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

PPM Trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post-haemorrhoidectomy pain

Haemorrhoids

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

400mg oral metronidazole three times daily versus placebo for 7 days post-haemorrhoidectomy in addition to standard analgesic care for both groups.

Standard analgesic regimen is as follows; 1000mg oral paracetamol four times a day, 50mg diclofenac three times a day for 7-10 days, one macrogol 3350 13.8g sachet daily, oxycodone 5mg 6-hourly as required (20 tablets supplied).

No specific monitoring strategies regarding compliance for the intervention drug was established. Patients were counselled to complete the course of trial medication as prescribed and also to report any potential side-effects. A list of common side-effects was included with the patient information and consent for and also contained within the trial questionnaire.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Matching placebo (composed of 'Avicel' microcrystalline cellulose) capsules three times daily for 7 days

Control group

Placebo

Outcomes

Primary outcome [1]

Daily pain scores for 21 days on a numerical rating scale

Timepoint [1]

Day of operation to 21 days post-operatively

Secondary outcome [1]

Overall satisfaction with surgery via satisfaction survey at routine post-operative follow-up appointment

Satisfaction was measured on a 7-point scale from very dissatisfied, dissatisfied, slightly dissatisfied, not sure, slightly satisfied, satisfied to very satisfied. This scale was modified from a previous study examining surgical satisfaction post-haemorrhoidectomy.

Timepoint [1]

4 weeks post-operatively

Secondary outcome [2]

Surgical complications via study specific questionnaire, clinical examination at routine post-operative follow-up appointment and medical records

Complications include bleeding, infection, urinary retention, faecal incontinence or constipation, anal canal stenosis

Timepoint [2]

Up to 4 weeks post-operatively

Secondary outcome [3]

Medication related side-effects study specific questionnaire, patient history at routine post-operative follow-up appointment and medical records

Possible side-effects abdominal discomfort, nausea, vomiting, headache, rash or itch

Timepoint [3]

Up to 4 weeks post-operatively

Eligibility

Key inclusion criteria

Males and females between 18-70 years of age undergoing elective haemorrhoidectomy and able to provide voluntary consent for the procedure and to participate in the trial.

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Renal impairment (eGFR <50, severe ischemic heart disease, active peptic ulcer disease, alcoholism and IV opiate dependency, severe aspirin-sensitive asthma, pregnant women, institutionalised patients, patients unable to provide consent, patients with chronic pain conditions, hypersensitivity or known intolerance to metronidazole, NSAIDs or oxycodone.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a random number generator via computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Continuous and ordinal variables were compared using a Mann-Whitney test, with reporting of median values and interquartile ranges. Categorical variables were compared using Fisher’s exact test, with presentation of percentage values. To assess significance of change over the time-course of the trial of pain and defaecation pain scores, we employed multilevel mixed effects modelling utilizing the “xtmixed” command in STATA. This permits assessment of the significance of both changes in patients’ individual pain scores as a function of time and separately as the interaction of time with treatment allocation (placebo versus metronidazole).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

2/04/2015

Date of last participant enrolment

Anticipated

Actual

28/02/2018

Date of last data collection

Anticipated

Actual

31/03/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Box Hill Hospital - Box Hill

Recruitment hospital [2]

Maroondah Hospital - Ringwood East

Recruitment hospital [3]

Angliss Hospital - Upper Ferntree Gully

Recruitment postcode(s) [1]

3128 - Box Hill

Recruitment postcode(s) [2]

3135 - Ringwood East

Recruitment postcode(s) [3]

3156 - Upper Ferntree Gully

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Colorectal Unit, Department of Surgery, Eastern Health

Address [1]

Box Hill Hospital, 5 Arnold St, Box Hill VIC 3128

Country [1]

Australia

Primary sponsor type

Individual

Name

Bruce Wilkie

Address

C/O Department of Surgery, Box Hill Hospital, 5 Arnold St, Box Hill VIC 3128

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Eastern Health Human Research and Ethic s Committee

Ethics committee address [1]

8 Arnold St, Box Hill VIC 3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

27/08/2014

Ethics approval number [1]

E02/2014

Summary

Brief summary

Pain is an expected problem after haemorrhoidectomy surgery and there have been a number of studies that have examined metronidazole in helping to reduce post-operative pain. The results are conflicting and the purpose of this study is to further examine the role of oral metronidazole plus standardised analgesia in reducing post-heamorrhoidectomy pain and compare its efficacy to placebo plus standardised analgesia.

Trial website

None

Trial related presentations / publications

Public notes

e-Poster: Wilkie B, Chandra R, Lam D, Chua J, Keck J, ‘Post-haemorrhoidectomy Pain and Metronidazole (PPM Trial): Protocol design for a double-blind randomised controlled trial’, Australian Scientific Congress, Royal Australasian College of Surgeons, Adelaide May 2017

Contacts

Principal investigator

Name

Dr Bruce Wilkie

Address

C/O Department of Surgery, Box Hill Hospital, 5 Arnold St, Box Hill VIC 3128

Country

Australia

Phone

+61 431235672

Fax

brucedwilkie@gmail.com

Contact person for public queries

Name

Bruce Wilkie

Address

C/O Department of Surgery, Box Hill Hospital, 5 Arnold St, Box Hill VIC 3128

Country

Australia

Phone

+61 431235672

Fax

brucedwilkie@gmail.com

Contact person for scientific queries

Name

Bruce Wilkie

Address

C/O Department of Surgery, Box Hill Hospital, 5 Arnold St, Box Hill VIC 3128

Country

Australia

Phone

+61 431235672

Fax

brucedwilkie@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

This was not included in the study design and ethics proposal

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Efficacy of postoperative oral metronidazole for haemorrhoidectomy pain: a randomized double-blind, placebo-controlled trial.	2021	https://dx.doi.org/10.1111/codi.15291

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically