Trial of Open Milligan-Morgan Haemorrhoidectomy Versus Laser Closed Haemorrhoidectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mr PJ Moore, Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01342991
First received: April 14, 2011
Last updated: November 27, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention
Haemorrhoids
Haemorrhoidectomy
Milligan-Morgan Haemorrhoidectomy
Open Haemorrhoidectomy
Procedure: Laser Haemorrhoidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial of Open Milligan-Morgan Haemorrhoidectomy Versus Laser Closed Haemorrhoidectomy

Resource links provided by NLM:


Further study details as provided by Northern Lincolnshire and Goole Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Post operative pain relief [ Time Frame: 6 weeks post-operatively ] [ Designated as safety issue: No ]
    Visual Analogue Score (1 to 10) willbe used to quantitatively assess pain outcomes.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: Immediately pre-operatively and again at 6 weeks post-operatively ] [ Designated as safety issue: No ]
    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.

  • analgesia consumption [ Time Frame: 6 weeks post-operatively ] [ Designated as safety issue: No ]

    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.



Enrollment: 40
Study Start Date: December 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Milligan-Morgan Haemorrhoidectomy
Control arm
Procedure: Laser 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

Other Name: Laser Seal Haemorrhoidectomy
Experimental: Laser Haemorrhoidectomy
This new method of haemorrhoidectomy is being compared to the standard Milligan-Morgan Haemorrhoidectomy.
Procedure: Laser 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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342991

Locations
United Kingdom
Northern Linconshire & Goole NHS Foundation trust
Goole, North Lincolnshire, United Kingdom, DN14 6RX
Sponsors and Collaborators
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Peter J Moore, MD, FRCS Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Mr PJ Moore, Consultant Surgeon, Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01342991     History of Changes
Other Study ID Numbers: 09/H1305/59
Study First Received: April 14, 2011
Last Updated: November 27, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Northern Lincolnshire and Goole Hospitals NHS Foundation Trust:
Haemorrhoids
Haemorrhoidectomy
Laser Haemorrhoidectomy
Milligan-Morgan Haemorrhoidectomy
Open Haemorrhoidectomy

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014