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HaemorrhoidsNCT01342991

Trial of Open Milligan-Morgan Haemorrhoidectomy Versus Laser Closed Haemorrhoidectomy

A study testing Laser Haemorrhoidectomy in people with Haemorrhoids and Haemorrhoidectomy, run by Northern Lincolnshire and Goole Hospitals NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomised trial to compare both the procedures and the difference in their immediate postoperative pain, recovery and quality of life. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laser Haemorrhoidectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
Dec 2009to Nov 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are fit enough to undergo general anaesthesia
  • Are between the age of 18 and 80 years
  • Are able and willing to provide informed consent
  • Show no preference to either operative procedure and agree to randomization
  • No contra-indications to receiving laser treatment

Who cannot join

  • Are not fit enough to undergo a general anaesthesia
  • Are not over the age of 18 years
  • Are unable or unwilling to provide informed consent
  • Have stated their operation preference
  • Have any contra-indication preventing them from receiving laser treatment
  • Have a history of non-compliance

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Northern Linconshire & Goole NHS Foundation trust

    Goole, North Lincolnshire, DN14 6RX

Other trials in United Kingdom

About this study

Official title: Randomised Controlled Trial of Open Milligan-Morgan Haemorrhoidectomy Versus Laser Closed Haemorrhoidectomy

This is a randomised trial to compare both the procedures and the difference in their immediate postoperative pain, recovery and quality of life.

Read the detailed description

Haemorrhoidectomy (excision of haemorrhoids) is the procedure of choice for grade 3 \& 4 symptomatic haemorrhoids. The standard technique in the UK (open Milligan-Morgan) is to excise the haemorrhoids under general anaesthetic (typically using electrocautery) leaving raw areas in anal canal. As a result, patients often experience significant post operative pain which can impact on patient function for weeks following surgery. This would be considered as the gold standard for the operative treatment for haemorrhoids. Due to the difficult post operative recovery of this procedure, alternative techniques for performing haemorrhoidectomy have been explored. One approach, which is gaining some popularity, is stapled haemorrhoidectomy [1]. In this technique, a circular stapling device is used to excise proximal mucosa in order to disconnect the haemorrhoidal blood supply and to pull up the haemorrhoidal mass. The edges of the excised mucosa are simultaneously closed with a row of staples. In a recent meta-analysis of 29 randomised controlled trials including 2056 patients, stapled haemorrhoidectomy was associated with reduced postoperative pain and reduction in return to activity by nearly 12 days in comparison to open haemorrhoidectomy [2]. Although postoperative complication rates were similar, stapled haemorrhoidectomy was associated with significantly more recurrences in the longer term (relative risk 2.29). The stapled haemorrhoidectomy technique has not gained universal acceptance. This may be related to the cost and availability of stapling devices in many centres.

Unlike specialized stapling devices, lasers are widely available in the operating theatre and are used in many operations to cauterise tissue. The resulting burn is superficial in comparison to electrocautery. Consequently, lasers have been used to perform open haemorrhoidectomy with the expectation of reducing post operative pain. However, randomised trials comparing the use of lasers versus cold scalpel for open haemorrhoidectomy have shown no significant differences in post operative pain [3]. Although, the laser appears to offer no advantage in open haemorrhoidal procedures, an alternative technique for laser haemorrhoidectomy has been developed by Peter Thompson from Laser Haemorrhoid Centre in Phoenix, Arizona. In this alternative technique, a laser is used to seal the raw mucosal edges after excision of the piles. In common with stapled haemorrhoidectomy, the mucosa is sealed closed rather than left open. Consequently, patients appear to experience markedly less post operative pain. The technique is also simple and quick with a shallow learning curve. Due to the speed and relative comfort of the procedure, patients may be routinely operated on using sedation and local anaesthetic, rather than full general anaesthetic which is standard practice for most haemorrhoidectomies.

Over the last 2 years,the investigators have performed laser haemorrhoidectomy for 60 patients. The age range was 32 to 81 years .The ratio for male: female was 31:29. All were done under local anaesthesia with sedation except one (1.6%) which was converted to general anaesthesia. All patients except 2 (3.5%) were discharged within two hours of operation. One was delayed due to administration of general anaesthesia and the second one was admitted for post operative bleeding and was actively observed for three days, after which he was discharged. There were four re-admissions (6.6%), two had post operative oedema \& two had oedema and pain. All of them were actively observed and discharged later. Four patients (6.6%) also developed chronic anal fissures post operatively, two of them healed with six weeks course of Glyceryl Tri Nitrate (GTN) cream and the other two are on conservative management for non-healing fissures.

The investigators wish to objectively determine whether laser closed haemorrhoidectomy is associated with significantly less post operative pain and an earlier return to function in comparison to the Milligan-Morgan Haemorrhoidectomy which is the standard procedure performed across the trust.

Being tested
Laser Haemorrhoidectomy
Keywords
Haemorrhoids, Haemorrhoidectomy, Laser Haemorrhoidectomy, Milligan-Morgan Haemorrhoidectomy, Open Haemorrhoidectomy
Medical subject headings
Hemorrhoids

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laser HaemorrhoidectomyProcedure or surgery

    Also called Laser Seal Haemorrhoidectomy

    The intervention comprises laser haemorrhoidectomy

    This procedure will be performed under local anaesthetic with sedation as a day case

    The haemorrhoids are excised using sharp dissection (over a clamp) and the cut edges are sealed using CO2 laser.

    Pre-operative local anaesthesia will be given

  • Laser HaemorrhoidectomyProcedure or surgery

    The intervention comprises laser haemorrhoidectomy

    This procedure will be performed under local anaesthetic with sedation as a day case

    The haemorrhoids are excised using sharp dissection (over a clamp) and the cut edges are sealed using CO2 laser.

    Pre-operative local anaesthesia will be given

Study groups in NCT01342991
Study groupRoleWhat they receive
Milligan-Morgan HaemorrhoidectomyActive comparatorControl arm
Receives: Procedure: Laser Haemorrhoidectomy
Laser HaemorrhoidectomyExperimentalThis new method of haemorrhoidectomy is being compared to the standard Milligan-Morgan Haemorrhoidectomy.
Receives: Procedure: Laser Haemorrhoidectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post operative pain relief

    Visual Analogue Score (1 to 10) willbe used to quantitatively assess pain outcomes.

    Measured: 6 weeks post-operatively

Secondary outcomes (2)
  1. Quality of life

    SF12 forms will be filled by the patients pre-operatively and again at 6 weeks post-operatively to assess any change in the quality of life this procedure may provide and compare the results between the two procedures.

    Measured: Immediately pre-operatively and again at 6 weeks post-operatively

  2. analgesia consumption

    patients maintain a pain medication diary in which they document the amount of analgesia they have consumed in the post-operative period.

    They are all given a standard regime of analgesics post-operatively unless there are any contra-indications.

    Measured: 6 weeks post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2011 (estimated)
  2. Study startDec 2009
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01342991
Sponsor's protocol ID
09/H1305/59
Status last verified
Nov 2011
First submitted
14 Apr 2011
Last updated
29 Nov 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Laser Haemorrhoidectomy in people with Haemorrhoids and Haemorrhoidectomy, run by Northern Lincolnshire and Goole Hospitals NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post operative pain relief (time frame: 6 weeks post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2011.

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