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NCT Number: NCT04944407

Minimal Invasive Laser Hemorrhoidoplasty vs Conventional Excisional Hemorrhoidectomy in II-III Grade Hemorrhoidal Disease

the study aims to evaluate the effectiveness and long term outcomes of laser hemorroidoplasty versus conventional milligan morgan hemorrhoidectomy in II-III degree hemorroidal disease.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Campania Luigi Vanvitelli

Naples, 80131, Italy

About this study

Background Hemorrhoidal disease (HD) is a widespread condition and several surgical techniques have been proposed to date without achieving a definitive consensus. Laser Hemorrhoidoplasty (LHP) is a minimal invasive procedure for HD treatment determining the shrinkage of the hemorrhoidal piles by diode laser limiting the postoperative discomfort and pain. The aim of the current prospective randomized trial is to evaluate the postoperative outcomes of HD patients undergoing LHP vs conventional Milligan-Morgan hemorrhoidectomy (MM).

Methods. Operative time, postoperative pain and complications, resolution of symptoms, patients 'quality of life, patients' evaluation of treatment and length of return to daily activity of II-III grade symptomatic HD patients undergoing LHP vs MM were prospectively evaluated. The patients were followed-up for 24 months looking for recurrence of prolapsed hemorrhoid or symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • II-III hemorrhoidal disease
  • failure of conservative treatment
  • ASA I-II

Exclusion criteria

  • acutely thrombosed hemorrhoids
  • patients affected by IBD involving rectum or anus
  • patients previously surgically treated for hemorrhoidal disease and the inability to complete study protocol

Treatment and study plan

LHP

Procedure

A skin microincision of 3 mm was made about 1 to 1.5 cm of distance from the anal verge at the base of each hemorrhoidal node. The probe (1.85 mm of diameter) was driven through the incision in the submucosal tissue until reaching the area underneath the distal rectal mucosa. Then, ten to twelve effective pulses (adjusted to respective node dimensions), 8 watt per 3 seconds each, of approximately 24 Joule using a 1470-nm diode laser generator (LEONARDO® DUAL 45 Biolitec® Jena, Germany) were fired. Half of them were fired in the submucosal tissue, the others in the intra-nodal compartment determining the shrinkage of the hemorrhoidal piles. The anal wounds were left open. At the end of the procedure an anal tampon was positioned.

MM

Procedure

The hemorrhoidectomy was performed by radiofrequency (LigaSure TM Small Jaw® Covidien®, Colorado, USA) or ultrasound (Focus® Ultracision® harmonic scalpel; Ethicon Endo-Surgery®, Inc., Cincinnati, Ohio). The anodermal wedge was incised, eventually removing external fibrosis and/or skin tags when present. Upward dissection started at this level with en-bloc excision of mucosal and submucosal layers from the underlying internal anal sphincter up to the anorectal ring. A compressive haemostatic sponge was left in place for 12-24 hours.

Primary outcomes

  1. Pain evaluation

    Time frame: 30 postoperative days.

    postoperative pain assessment with Visual Analogue Scale Score

  2. Analgesic use

    Time frame: 30 postoperative days.

    use of analgesic drugs in the postopertive days

Secondary outcomes

  1. Presence of recurrence

    Time frame: 24 months

    Patients were considered to have recurrent hemorrhoidal symptoms when any of the following were recorded: bleeding, itching, pain or discomfort affecting patient's perception of quality of life, which could either be associated or not to prolapse recurrence. The Rovrik' score was adopted to assess this issue.

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

Minimal Invasive Laser Hemorrhoidoplasty vs Conventional Excisional Hemorrhoidectomy in II-III Grade Hemorrhoidal Disease: a Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Jun 29, 2021
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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