Minimal Invasive Laser Hemorrhoidoplasty vs Conventional Excisional Hemorrhoidectomy in II-III Grade Hemorrhoidal Disease
Primary Purpose
Hemorrhoids
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
LHP
MM
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoids
Eligibility Criteria
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
Sites / Locations
- University of Campania Luigi Vanvitelli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LHP GROUP
MM GROUP
Arm Description
patients recieved minimal invasive LHP procedure with diode laser
patients received conventional MM hemorroidectomy
Outcomes
Primary Outcome Measures
Pain evaluation
postoperative pain assessment with Visual Analogue Scale Score
Analgesic use
use of analgesic drugs in the postopertive days
Secondary Outcome Measures
Presence of recurrence
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.
Full Information
NCT ID
NCT04944407
First Posted
June 15, 2021
Last Updated
June 21, 2021
Sponsor
University of Campania "Luigi Vanvitelli"
1. Study Identification
Unique Protocol Identification Number
NCT04944407
Brief Title
Minimal Invasive Laser Hemorrhoidoplasty vs Conventional Excisional Hemorrhoidectomy in II-III Grade Hemorrhoidal Disease
Official Title
Minimal Invasive Laser Hemorrhoidoplasty vs Conventional Excisional Hemorrhoidectomy in II-III Grade Hemorrhoidal Disease: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LHP GROUP
Arm Type
Experimental
Arm Description
patients recieved minimal invasive LHP procedure with diode laser
Arm Title
MM GROUP
Arm Type
Active Comparator
Arm Description
patients received conventional MM hemorroidectomy
Intervention Type
Procedure
Intervention Name(s)
LHP
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
MM
Intervention Description
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 Outcome Measure Information:
Title
Pain evaluation
Description
postoperative pain assessment with Visual Analogue Scale Score
Time Frame
30 postoperative days.
Title
Analgesic use
Description
use of analgesic drugs in the postopertive days
Time Frame
30 postoperative days.
Secondary Outcome Measure Information:
Title
Presence of recurrence
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Campania Luigi Vanvitelli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
I am not sure in the current study phase
Learn more about this trial
Minimal Invasive Laser Hemorrhoidoplasty vs Conventional Excisional Hemorrhoidectomy in II-III Grade Hemorrhoidal Disease
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