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Bleeding in Laser Haemorrhoidoplasty

NCT04667169 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-12-21

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Shu Yu Lim, MSurg · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04667169 on ClinicalTrials.gov