Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Alexander Hardy

ORCID ID

Contact details

North West London Hospitals NHS Trust
St Mark's Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
+44 (0)20 8235 4019
hardystmarks@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0515150705

Study information

Scientific title

Acronym

Study hypothesis

Which of the two most popular surgical techniques for removing haemorrhoids causes least pain, and fastest healing?

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

Patients will be fully informed about the project and written consent will be obtained prior to their enrollment in the study. Operations will be carried out under general anaesthetic, either as a day case procedure, or as an inpatient as appropriate. At the time of operation the haemorrhoids will be assessed, and each haemorrhoid swelling randomised to either the 'open' or 'closed' procedure by the toss of a coin. The haemorrhoid will be removed according to the technique randomly chosen. The haemorrhoid on the opposite side of the anus will have the other procedure performed. Any further haemorrhoids will be randomised in the same way. The operative techniques for the two procedures will be standardised so all surgeons operating in the study perform them in the same way.
An established protocol will be used for the preoperative and postoperative management of the patients. This will include 3 days of lactulose (a stool softener) prior to the operation, and a discharge pack of lactulose, metronidazole (an antibiotic which has been found to help with pain relief after such operations), diltiazem cream (which relaxes the sphincter, relieving post operative pain) and diclofenac (a painkiller). This is the standard regime for all patients having haemorrhoid surgery. After the operation, patients will be given a diagram of the positions of the removed haemorrhoids. They will be asked to rank the wounds in order of painfulness at the end of each day. They will also be asked to complete daily pain scores on a 10cm visual analogue scale, recording both experienced and expected pain. The day of the first post operative bowel action will also be recorded, as well as pain scores for this and subsequent bowel actions. Patients will be asked to keep diary cards for the two weeks following their operation.
Patients will be assessed in the Outpatient clinic at 2 weeks, 6 weeks and 6 months following the operation. At these appointments any complications will be noted, and the wounds inspected. At the two week appointment a digital photo will be taken of the healing wounds. These will be assessed by a blinded observer and marked on a scale of 1 to 10 (with 1 being complete healing, and 10 being very poor wound healing.) The time taken to return to normal activities and work will also be recorded.

Added July 2008: the trial was stopped due to lack of participants.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Results of the haemorrhoidectomy technique used in terms of post operative pain scores and healing rates.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2004

Overall trial end date

01/03/2006

Reason abandoned

Lack of participants

Eligibility

Participant inclusion criteria

Patients undergoing haemorrhoidectomy for symptomatic Grade III and Grade IV haemorrhoids.
The Chief Investigator will approach the patients in clinic or on the ward and explain the study with both verbal and written information. Those patients willing to participate in the study will be recruited following a full explanation of what is involved and written consent.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2004

Recruitment end date

01/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North West London Hospitals NHS Trust
Harrow
HA1 3UJ
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

North West London Hospitals NHS Trust (UK)

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