A randomised trial of open vs closed haemorrhoidectomy on the same patient

ISRCTN	ISRCTN83816740
DOI	https://doi.org/10.1186/ISRCTN83816740
Secondary identifying numbers	N0515150705

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 12/04/2011

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Alexander Hardy
Scientific

North West London Hospitals NHS Trust
St Mark's Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom

Phone	+44 (0)20 8235 4019
Email	hardystmarks@yahoo.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	Which of the two most popular surgical techniques for removing haemorrhoids causes least pain, and fastest healing?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2004
Completion date	01/03/2006
Reason abandoned (if study stopped)	Lack of participants

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/2004
Date of final enrolment	01/03/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

North West London Hospitals NHS Trust

Harrow
HA1 3UJ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

North West London Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan