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

April 14, 2011
November 27, 2011
December 2009
November 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01342991 on ClinicalTrials.gov Archive Site
  • 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.

Same as current
Not Provided
Not Provided
 
Trial of Open Milligan-Morgan Haemorrhoidectomy Versus Laser Closed Haemorrhoidectomy
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Haemorrhoids
  • Haemorrhoidectomy
  • Milligan-Morgan Haemorrhoidectomy
  • Open 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

    Other Name: Laser Seal 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

  • Active Comparator: Milligan-Morgan Haemorrhoidectomy
    Control arm
    Intervention: Procedure: Laser Haemorrhoidectomy
  • Experimental: Laser Haemorrhoidectomy
    This new method of haemorrhoidectomy is being compared to the standard Milligan-Morgan Haemorrhoidectomy.
    Intervention: Procedure: Laser Haemorrhoidectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01342991
09/H1305/59
Yes
Mr PJ Moore, Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
Not Provided
Principal Investigator: Peter J Moore, MD, FRCS Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP