Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
11/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Muzaffar Ahmad

ORCID ID

Contact details

Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe General Hospital
Cliff Gardens
Scunthorpe
DN15 7BH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084144553

Study information

Scientific title

Acronym

Study hypothesis

Does the completely closed and sutured technique of haemorrhoidectomy reduce discomfort and enhances healing in comparison to the standard open method?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Haemorrhoidectomy

Intervention

All patients diagnosed as having grade 3 or 4 haemorrhoids and require corrective surgery who fulfil the inclusion criteria seen in the general surgical outpatient department of Scunthorpe And Goole hospitals will be invited to take part in the study until the sample size has been achieved.
After patients have agreed to participate, they will be randomised into one or other of the treatment arms: 'standard open' haemorrhoidectomy vs 'completely closed and sutured' technique.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. A routine follow up clinical appointment will be sent to the patient at 4 weeks after surgery. Extent of healing will be scored on a scale from 1-4. (1:<25%; 2:25-50%; 3:50-75%; 4:complete healing).
2. Post operative SF 36 questionnaire at 4 weeks after surgery
3. Duration in days taken to return to normal daily activities
4. Percent satisfaction after the procedure
5. Consent to undergo the procedure again if required

Secondary outcome measures

Not provided at time of registration

Overall trial start date

02/01/2002

Overall trial end date

02/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

With reference to previously published studies, comparing open versus stapled techniques a similar sample size n=20 in each arm was arrived at.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

02/01/2002

Recruitment end date

02/01/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe
DN15 7BH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes