Bleeding in Laser Haemorrhoidoplasty

NCT04667169 | Completed

• 1 other identifier: NMRR-15-1112-24065
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemorrhoids

Keywords

Laser Haemorrhoidoplasty; Haemorrhoidal Artery Ligation; Haemorrhoids

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Pain score

  One day

• Pain score

  One week

• Pain score

  Six weeks

• The presence of perianal swelling

  One day

• The presence of perianal swelling

  One week

Study Arms (2)

Laser Haemorrhoidoplasty

EXPERIMENTAL

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

Haemorrhoidal Artery Ligation

EXPERIMENTAL

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

Interventions

Haemorrhoidal Artery Ligation PROCEDURE

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.

Haemorrhoidal Artery Ligation

Laser Haemorrhoidoplasty PROCEDURE

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.

Laser Haemorrhoidoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya

Kuala Lumpur, 50603, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 35449097 DERIVED

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shu Yu Lim, MSurg

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 14, 2020
• Study Start: January 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)