Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00503269 |
Other study ID # |
AA/dd |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 2005 |
Est. completion date |
July 2007 |
Study information
Verified date |
September 2023 |
Source |
East Kent Hospitals University NHS Foundation Trust |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Background: Local anaesthetic day-care open haemorrhoidectomy (LH) is feasible, cheap and may
be the cost-effective surgical approach to third degree haemorrhoids. This prospective
randomised controlled trial compares patient's evaluation of LH with general anaesthetic
day-care Park's modified Milligan-Morgan haemorrhoidectomy (GH).
Methods: 41 patients with third degree haemorrhoids were randomised to LH (19 cases) and GH
(22 cases). Demographics were comparable. Independent assessment (by a research nurse) and
clinical evaluation ran parallel for 6 months. Outcome measures were average and expected
pain scores for 10 days; satisfaction scores at 10 days, 6 weeks and 6 months. Secondary
outcomes were journey time and cost in day surgery.
Description:
INTRODUCTION:
Open haemorrhoidectomy is a commonly performed painful operation. In 1998-99, 26514
haemorrhoidectomies were performed in the UK of which 14373 were day cases. A further 5342
could have been performed as day surgery1. Improvements in multimodal2 and pre-emptive
analgesia3, introduction of stapled anopexy4 and improvements in patient counselling5 have
led to increasing number of day surgical treatment of haemorrhoids. Technique of LH is
described6-11 but with the paucity of randomised controlled trials this is rarely offered as
a routine choice to patients with third degree haemorrhoids.
AIM:
This randomised controlled trial compares patient-evaluation of postoperative pain and
expected pain scores for 10 days and satisfaction scores at 10 days, 6 weeks and 6 months
between local and general anaesthetic day surgical open haemorrhoidectomy. Clinical outcomes
(for 6 months), cost comparison and evaluation of total journey time in day surgical unit
formed part of the study.
PATIENTS AND METHODS:
This randomised controlled trial was approved by the Research and Development department and
the Local Research Ethics committee. We performed a pilot evaluation of ten-day average pain
and expectation scores after LH in 7 patients. Based on the data from this pilot study and
the average pain scores from the literature for GH, we calculated a requirement of 40
patients to give a 90% power to the study at the 5% significance level (student's t-test) to
detect a 22% difference in 10 day average pain scores with a standard deviation of 1.712.
Null hypothesis was that there was no difference in the pain scores between the two groups.
Forty two patients with third degree haemorrhoids had full explanation of the trial (verbal
and written with copies sent to their GP) and were randomised [Figure 1] on the day of
surgery after consent. Patients unfit for day-surgery were excluded. Computer generated
random numbers with opaque envelopes [produced by the principal researcher (GNR)] were opened
by the research nurse (WH) after obtaining the research consent.
Verbal and written information of the expected postoperative course following open
haemorrhoidectomy were given to all patients. This leaflet detailed the measures to take in
the event of constipation or difficulty in passing urine, if such a problem arose. They were
given the research nurse's contact number, in the event of a problem and were advised to
contact out-of-hours GP service or the research nurse.
Research nurse [WH] assessed their pain and expectation scores in the post operative period
on the day of surgery and spoke to all the patients on the day after surgery to record their
comments and reinforce the importance of accurate scoring. Patients then recorded their pain
and expectation scores at home for 10 days. This was the average of the pain that the
patients experienced before, during and after defecation or the average of the pain during
the course of the day. Two patients failed to return their 10 day pain scores [7%].
Pain scores were recorded on a ten-point Visual-analogue scale with scores from 1 to 10, with
1 being 'no pain' and 10 being 'as bad as it could be'. Ten-point patient expectation score
was -5 to 5 with -5 being 'much better than expected' and 5 being 'much worse than expected'.
Seven point satisfaction score was -3 to 3 with -3 being 'extremely dissatisfied' and 3 being
'extremely satisfied'.
Clinical follow-up by the surgeon (NGR) at 10 days, 6 weeks and 6 months evaluated the
surgical outcome and recorded all surgical complications. Patients sent their satisfaction
scores directly to the research nurse at these time-points and were un-influenced by the
surgical out-patient visit.
All haemorrhoidectomies [Park's modified Milligan-Morgan technique13] were performed by a
single surgeon [NGR]. Prone-Jacknife position (with buttocks strapped apart) was used for
those randomised to local anaesthesia while Lithotomy-Trendelenburg position was used for
those undergoing the procedure under general anaesthesia. Those with Type B and C buttocks10
needed more Trendelenburg position.
Perianal block was used for all patients irrespective of their randomisation. GH were given
the block prior to commencement of surgery. This was performed with 20 ml of 1% Lignocaine
(with 1 in 10000 Adrenaline) injected at four sites [midline anterior and posterior; left and
right lateral], fanning the needle in three directions at each of the four sites; care being
taken to inject outside the external sphincter, to avoid pain. Once the sphincter muscle
relaxed with the perianal block, a further 10 ml of the same anaesthetic was injected
submucosally raising a bleb in each of sites corresponding to the sites of perianal block.
This bleb was massaged inferiorly. No sedation was used with local anaesthetic
haemorrhoidectomy.
Following diathermy excision of haemorrhoids, a tube of lignocaine gel (Instillagel) was
instilled into the anal canal followed by insertion of a gram of metronidazole and 50 mg of
voltarol unless a history of asthma contraindicated the use of Voltarol in which case that
was omitted. A soft sponge 'pack' [curisponge] was subsequently inserted. Patients were
warned pre-operatively to expect the passage of the gelatinous curisponge in the
post-operative period with their first defaecation.
A package of medications was given to take home (TTA). TTA contained Co-codamol, Ibuprofen,
Metronidazole, Lactulose, Dulcolax, 5% lignocaine ointment and 2% Diltiazem cream, with
detailed instructions on its usage. Message in the post-operative instruction leaflet was
reiterated prior to discharge.
Journey time was calculated as the time elapsed between the start of anaesthesia and patient
going home.
Infection was defined as presence of purulent discharge with heightened pain, a visit to
their general practitioner and use of antibiotics over and above the Metronidazole prescribed
on discharge.
Sum of the individual costs of the suture material, anaesthesia, cost of day surgery staff,
recovery room costs and post operative medications were the basis of cost analysis.
Statistical analysis:
Data collected on Microsoft Excel was analysed on 'Analyse-it for Microsoft Excel'
[Analyse-it Software Ltd, Leeds, UK]. Chi-square test and Mann-Whitney U test were used.
Where the data was normally distributed as in the comparison of age, student's t-test was
used. Serial measurements on linear analogue pain score were summarised by calculating the
average pain over the 10-day time period for each patient as a summary measure14.