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

NACompletedINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

January 1, 2017

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2020

Conditions
Hemorrhoids
Interventions
PROCEDURE

LHP

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.

PROCEDURE

MM

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.

Trial Locations (1)

80131

University of Campania Luigi Vanvitelli, Napoli

All Listed Sponsors
lead

University of Campania Luigi Vanvitelli

OTHER

NCT04944407 - Minimal Invasive Laser Hemorrhoidoplasty vs Conventional Excisional Hemorrhoidectomy in II-III Grade Hemorrhoidal Disease | Biotech Hunter | Biotech Hunter