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

Not Applicable

Completed

• Conditions: Hemorrhoids
• Interventions: Procedure: LHP; Procedure: MM

• Registration Number: NCT04944407
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-21
• Last Update Submitted: 2021-06-21
• Study First Posted: 2021-06-29
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LHP GROUP	LHP	patients recieved minimal invasive LHP procedure with diode laser
MM GROUP	MM	patients received conventional MM hemorroidectomy

Primary Outcome Measures

Name	Time	Method
Pain evaluation	30 postoperative days.	postoperative pain assessment with Visual Analogue Scale Score
Analgesic use	30 postoperative days.	use of analgesic drugs in the postopertive days

Secondary Outcome Measures

Name	Time	Method
Presence of recurrence	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.

Trial Locations

Locations (1)

University of Campania Luigi Vanvitelli; 🇮🇹 Napoli, Italy