Bleeding in Laser Haemorrhoidoplasty

Comparison of Post-operative Bleeding Incidence in Laser Haemorrhoidoplasty Versus Laser Haemorrhoidoplasty With Haemorrhoidal Artery Ligation: A Double-Blinded Randomized Controlled Trial

Treatment options for haemorrhoid can be classified mainly into lifestyle modification, medical and procedural. Laser haemorrhoidoplasty (LHP) is a minimally invasive procedure which is effective in treating grade 2-4 haemorrhoids. However, one of the significant complications is post-operative bleeding. Some surgeons supplemented haemorrhoidal artery ligation (HAL) to help minimize post-operative bleeding, however, its effectiveness has not been formally evaluated. This study aims to compare the effectiveness of supplementation of HAL to LHP in reducing the incidence of post-operative bleeding. It was hypothesize that supplementation of HAL to LHP is not effective in reducing the post-operative bleeding incidence and is unnecessary. The study was designed as a double-blind, randomized controlled trial involving 78 patients who underwent laser haemorrhoidoplasty in Universiti Malaya Medical Centre, Malaysia from November 2016 to October 2018. The study compared the post-operative bleeding incidence of laser haemorrhoidoplasty (LHP) only (n=38) versus laser haemorrhoidoplasty with haemorrhoidal artery ligation (LHP + HAL) (n=38). Assessment of bleeding using verbal rating scale (VRS) and Clavien-Dindo score is made at post-operative 24 hours, one week and six weeks. Pain score, the presence of perianal swelling and operation time were documented.

Study Overview

• Status: Completed
• Conditions: Hemorrhoids
• Intervention / Treatment: Procedure: Laser Haemorrhoidoplasty; Procedure: Haemorrhoidal Artery Ligation

Detailed Description

Symptomatic haemorrhoids is a very common condition. The exact number of haemorrhoid sufferers is difficult to estimate because many do not seek medical help and rely on over the counter medications. Treatment options for haemorrhoids can be largely classified into lifestyle modification, medical and procedural. Procedural treatment can be further classified into excisional (involves excision of tissue) and non-excisional. Many procedures have been described and there is a preference for minimally invasive procedures and to avoid excisional procedures currently as they cause significantly more pain. Furthermore, many studies have shown that the post-operative complication rates and recurrence rates are relatively low for non-excisional procedures. In recent years, LHP had been introduced. It is an example of non-excisonal procedure for haemorrhoid. The delivery of laser energy to the anal cushion results in inflammation and scarring, which leads to contraction and fixation of haemorrhoids. The potential advantage of this procedure is less pain, as it does not involve. excision or passage of suture. Nevertheless, one of the post-operative conditions observed after LHP is bleeding. As this is a rather new procedure, there are limited studies conducted and the incidence of post-operative bleeding for laser haemorrhoidoplasty is not reported. To overcome this, some surgeons supplement haemorrhoidal artery ligation to laser haemorrhoidoplasty to minimize the incidence of post-operative bleeding, of which its effectiveness has not been formally evaluated. Moreover, the reported incidence of post-operative bleeding for HAL is 19-22%. In our institution experience, the post-operative bleeding rate for LHP is 1-2%. Therefore, the investigators hypothesize that supplementation of HAL to LHP is not effective in reducing the post-operative bleeding incidence and is unnecessary. This is an interventional study and is designed as a double-blinded randomized controlled trial to look into the post-operative bleeding incidence of patients undergoing LHP only versus LHP + HAL in UMMC. The study commenced in November 2016 and completed recruitment in October 2018. To show the effectiveness of supplementation of HAL to LHP in reducing the post-operative bleeding incidence, the investigators needed to study 35 experimental subjects and 35 control subjects to be able to reject the null hypothesis that the failure rate for experimental and control subjects are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. When a 10% dropout rate was factored in, the investigators needed 38 subjects in each arm. The investigators will use an uncorrected chi-squared statistic to evaluate this null hypothesis. Randomization in blocks of four was used to assign the LHP only group and LHP + HAL group. Each procedure after randomized was placed in an individually numbered envelope. Prior to the start of operation, the operating surgeon randomly selects one envelop. All patients had general anaesthesia or regional anaesthesia. A standard dose of Intravenous Cefoperazone 2 gm and Intravenous Metronidazole 500 mg was given. Post-operatively, all subjects were given tablet Paracetamol 1 gm six hourly and Capsule Celecoxib 200 mg 12 hourly as pain control for five days. They were given Syrup Lactulose 15 cc 12 hourly for one week to prevent constipation. Subjects were discharged on the same day or one day after surgery. All patients were assessed in the clinic by a nurse/medical officer blinded to the type of procedure performed on post-operative 24 hours, one week and six weeks. There were a total of 76 patients recruited for this study.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 50603
    • University of Malaya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 and above
• Diagnosed with symptomatic haemorrhoid
• Able to give informed consent
• Fit to undergo anaesthesia
• Agreeable for randomization and shows no preference for either group

Exclusion Criteria:

• Have stated a preference toward a certain treatment option
• Haemorrhoid condition requiring emergency surgery
• Haemorrhoids condition associated with other anorectal pathology such as fistula in ano, perianal abcess, and anal fissure
• Unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Haemorrhoidoplasty; A stab incision was made at the ano-cutaneous junction and the anodermis was tunneled with artery forceps to the pedicle of the haemorrhoids. The laser catheter was introduced submucosally towards the pedicle guided by a visible beam to ascertain the exact location of the laser fibre. This was then followed by about six pulsed laser energy delivered at five mm interval, while gradually withdrawing the laser catheter.	Procedure: Laser Haemorrhoidoplasty; Post-operatively, all subjects were given tablet Paracetamol 1 gm six hourly and Capsule Celecoxib 200 mg 12 hourly as pain control for five days. They were given Syrup Lactulose 15 cc 12 hourly for one week to prevent constipation. Subjects were discharged on the same day or one day after surgery. All patients were assessed in the clinic by a nurse/medical officer blinded to the type of procedure performed on post-operative 24 hours, one week and six weeks.
Experimental: Haemorrhoidal Artery Ligation; In addition to the delivery of laser energy as per the procedure described above, each identified pedicle was ligated with a suture, without Doppler guidance.	Procedure: Haemorrhoidal Artery Ligation; Post-operatively, all subjects were given tablet Paracetamol 1 gm six hourly and Capsule Celecoxib 200 mg 12 hourly as pain control for five days. They were given Syrup Lactulose 15 cc 12 hourly for one week to prevent constipation. Subjects were discharged on the same day or one day after surgery. All patients were assessed in the clinic by a nurse/medical officer blinded to the type of procedure performed on post-operative 24 hours, one week and six weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall post-operative bleeding incidence	The assessment was made using of bleeding using verbal rating scale and Clavien-Dindo score.	One day
Overall post-operative bleeding incidence	The assessment was made using of bleeding using verbal rating scale and Clavien-Dindo score.	One week
Overall post-operative bleeding incidence	The assessment was made using of bleeding using verbal rating scale and Clavien-Dindo score.	Six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	The assessment was made using the visual analogue scale (VAS)	One day
Pain score	The assessment was made using the visual analogue scale (VAS)	One week
Pain score	The assessment was made using the visual analogue scale (VAS)	Six weeks
The presence of perianal swelling	The assessment was documented as its presence or the absence	One day
The presence of perianal swelling	The assessment was documented as its presence or the absence	One week
The presence of perianal swelling	The assessment was documented as its presence or the absence	Six weeks
Operation time	The assessment was made based on the clinical records	Day 0

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Shu Yu Lim, MSurg, University of Malaya

Publications and helpful links

General Publications

• Lim SY, Rajandram R, Roslani AC. Comparison of post-operative bleeding incidence in laser hemorrhoidoplasty with and without hemorrhoidal artery ligation: a double-blinded randomized controlled trial. BMC Surg. 2022 Apr 21;22(1):146. doi: 10.1186/s12893-022-01594-z.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Haemorrhoids; Laser Haemorrhoidoplasty; Haemorrhoidal Artery Ligation
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: NMRR-15-1112-24065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No