Prospective Randomized Trial About THD Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids (THD-LIGA)

April 16, 2021 updated by: Sebastiano Biondo, Hospital Universitari de Bellvitge

Prospective Multicenter Randomized Trial About Transanal Hemorrhoidal Dearterialization With Mucopexy (THD) Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids

The study evaluates postoperative pain, morbidity, recurrence and quality of life, comparing two different strategies in the treatment of grade III and IV hemorrhoids: transanal hemorrhoidal dearterialization with mucopexy (THD) versus hemorrhoidectomy by Ligasure™.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Transanal hemorrhoidal dearterialization (THD)‪ uses a specially developed anoscope combined with a Doppler transducer to identify the hemorrhoidal arteries. A suture ligation is performed to effectively decrease the blood flow to the hemorrhoidal plexus. In case of redundant prolapse, the prolapsed mucosa is lifted (mucopexy). THD procedure is performed without any incisions or removal of the hemorrhoidal tissue and moreover the suture line is above the dentate line, so post-operative pain and morbidities seem to be minimized in these patients. This technique differs from Ligasure hemorrhoidectomy, which focuses on excising the hemorrhoidal tissue.

This prospective, randomized, multicenter and controlled trial compares post-operative pain, morbidities, quality of life, fecal incontinence and recurrence rate in patients treated for grade III and IV hemorrhoids with THD with mucopexy versus Ligasure hemorrhoidectomy.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Valle d'Hebron University Hospital
      • Leon, Spain, 24071
        • Complejo Asistencial Universitario de León
      • Madrid, Spain, 28040
        • Fundación Jiménez Díaz
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spain, 28046
        • Hospital La Paz
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Bellvitge University Hospital
    • Madrid
      • Mostoles, Madrid, Spain, 28933
        • Hospital Universitario Rey Juan Carlos
    • Ourense
      • O Barco de Valdeorras, Ourense, Spain, 32300
        • Hospital Comarcal de Valdeorras
    • Pais Vasco
      • Bizkaia, Pais Vasco, Spain, 48960
        • Galdakano Usansolo Hospital
    • Valencia
      • Alzira, Valencia, Spain, 46600
        • Hospital Universitario de La Ribera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with grade III and IV hemorrhoids according to Goligher classification
  • Patients ASA I, II or III and adequate hematological, renal and hepatic function
  • Patients who signed informed consent

Exclusion Criteria:

  • Altered cognitive state that prevents collaboration in the study or patients who can neither read nor write
  • Fecal incontinence
  • Anal sphincter lesions
  • Recurrent hemorrhoids after previous surgical tratment
  • Previous anorectal surgery except banding, botulinum toxin injection and thrombectomy for hemorrhoid thrombosis
  • Injection sclerotherapy during the last five years
  • Concomitant anorectal disease (anal fistula, anal fissure, anal stenosis, rectocele, enterocele, anal condilomatosis).
  • Concomitant diagnosis of functional pelvic floor disease, inflammatory bowel disease and previous pelvic radiotherapy
  • Concomitant diagnosis of colorectal neoplasia or other neoplasia
  • Patients ASA IV, V
  • NSAIDs, Paracetamol, Tramadol, Metamizol and Petidine allergy
  • Coagulation disorders
  • Pregnancy and lactation
  • Rejection of the patient to sign the consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: THD and mucopexy
Patients will undergo to transanal hemorrhoidal dearterialization with mucopexy (THD)‪ under generla anesthesia.
Device: Transanal hemorrhoidal dearterialization + mucopexy (THD).
Using an anoscope combined with a Doppler transducer the hemorrhoidal arteries are identified and ligated to decrease the blood flow to the hemorrhoidal plexus. In order to reduce hemorroidal prolapse a mucopexy is performed.
Device: THD anoscope and doppler
An dedicated anoscope with an incorporated doppler probe sold by THD Lab S.p.A will be used for the THD procedure
Active Comparator: Ligasure hemorroidectomy
Patients will undergo to Ligasure™ hemorroidectomy under generla anesthesia.
Procedure: Ligasure™ hemorrhoidectomy
Excisional hemorroidectomy performed with Ligasure™
Device: Ligasure Vessel Sealing
A curved, small jaw, open sealer/divider sold by Covidien/medtronic will be used for the Ligasure™ hemorrhoidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: within the first 30 days after surgery
Post-operative pain by simple verbal numerical scale (0-10), the Andersen scale (0-5) and the taken pain medicacions will be recorded by the patients on a specific book during the first thirty days after surgery.
within the first 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: At 1 month and at 1 and 2 years after surgery
Quality of life by Short Form 12 (SF-12) Questionnaire
At 1 month and at 1 and 2 years after surgery
Specific disabilities (fecal incontinence and costipation)
Time Frame: At the day 15, 30 and at 1 and 2 years after surgery
Fecal incontinence by Vaizey Score and need of laxatives. Anorecatal manometry and endoanal ultrasonography will be performed two month after surgery.
At the day 15, 30 and at 1 and 2 years after surgery
Post-operative morbidity
Time Frame: within the first 30 days after surgery
Dindo classification of complicacions will be used
within the first 30 days after surgery
Hemorrhoid recurrence
Time Frame: At 1 and 2 years after surgery
rectal bleeding, anal pain, mucosal prolaps will be invastigated one year after hemorroidectomy. Needing of further surgery for hemorrhoids recurrence will be recorded
At 1 and 2 years after surgery
Satisfaction after surgery
Time Frame: At the day 15, 30 and at 1 and 2 years after surgery
A scale of 0-3 (0, not satisfied; 1 few satisfied, 2 satisfied, 3, very satisfied) will be used.
At the day 15, 30 and at 1 and 2 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Investigators

  • Principal Investigator: Sebastiano Biondo, MD, Phd, Bellvitge University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

December 13, 2015

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THD_LIGA_RCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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