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

NCT04944407 | Completed

• 1 other identifier: laser hemorroid
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (2)

• Pain evaluation

  postoperative pain assessment with Visual Analogue Scale Score

  30 postoperative days.

• Analgesic use

  use of analgesic drugs in the postopertive days

  30 postoperative days.

Secondary Outcomes (1)

• Presence of recurrence

  24 months

Study Arms (2)

LHP GROUP

EXPERIMENTAL

patients recieved minimal invasive LHP procedure with diode laser

Procedure: LHP

MM GROUP

ACTIVE COMPARATOR

patients received conventional MM hemorroidectomy

Procedure: MM

Interventions

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.

LHP GROUP

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.

MM GROUP

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania Luigi Vanvitelli

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 29, 2021
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2020
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

IT (1)