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

Primary Purpose

Hemorrhoids

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Transanal hemorrhoidal dearterialization + mucopexy (THD).
Ligasure™ hemorrhoidectomy
THD anoscope and doppler
Ligasure Vessel Sealing
Sponsored by
Hospital Universitari de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoids focused on measuring Hemorrhoids grade III and IV, transanal hemorrhoidal dearterialization, hemorroidectomy, THD, LigaSure

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bellvitge University Hospital
  • Hospital Universitario Rey Juan Carlos
  • Hospital Comarcal de Valdeorras
  • Galdakano Usansolo Hospital
  • Hospital Universitario de la Ribera
  • Valle d'Hebron University Hospital
  • Complejo Asistencial Universitario de Leon
  • Hospital Universitario de La Princesa
  • Fundación Jimenez Diaz
  • Hospital La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

THD and mucopexy

Ligasure hemorroidectomy

Arm Description

Patients will undergo to transanal hemorrhoidal dearterialization with mucopexy (THD)‪ under generla anesthesia.

Patients will undergo to Ligasure™ hemorroidectomy under generla anesthesia.

Outcomes

Primary Outcome Measures

Post-operative pain
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 13, 2015
Last Updated
April 16, 2021
Sponsor
Hospital Universitari de Bellvitge
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1. Study Identification

Unique Protocol Identification Number
NCT02654249
Brief Title
Prospective Randomized Trial About THD Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids
Acronym
THD-LIGA
Official Title
Prospective Multicenter Randomized Trial About Transanal Hemorrhoidal Dearterialization With Mucopexy (THD) Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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™.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids
Keywords
Hemorrhoids grade III and IV, transanal hemorrhoidal dearterialization, hemorroidectomy, THD, LigaSure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
THD and mucopexy
Arm Type
Other
Arm Description
Patients will undergo to transanal hemorrhoidal dearterialization with mucopexy (THD)‪ under generla anesthesia.
Arm Title
Ligasure hemorroidectomy
Arm Type
Active Comparator
Arm Description
Patients will undergo to Ligasure™ hemorroidectomy under generla anesthesia.
Intervention Type
Device
Intervention Name(s)
Transanal hemorrhoidal dearterialization + mucopexy (THD).
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ligasure™ hemorrhoidectomy
Intervention Description
Excisional hemorroidectomy performed with Ligasure™
Intervention Type
Device
Intervention Name(s)
THD anoscope and doppler
Intervention Description
An dedicated anoscope with an incorporated doppler probe sold by THD Lab S.p.A will be used for the THD procedure
Intervention Type
Device
Intervention Name(s)
Ligasure Vessel Sealing
Intervention Description
A curved, small jaw, open sealer/divider sold by Covidien/medtronic will be used for the Ligasure™ hemorrhoidectomy
Primary Outcome Measure Information:
Title
Post-operative pain
Description
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.
Time Frame
within the first 30 days after surgery
Secondary Outcome Measure Information:
Title
Quality of life
Description
Quality of life by Short Form 12 (SF-12) Questionnaire
Time Frame
At 1 month and at 1 and 2 years after surgery
Title
Specific disabilities (fecal incontinence and costipation)
Description
Fecal incontinence by Vaizey Score and need of laxatives. Anorecatal manometry and endoanal ultrasonography will be performed two month after surgery.
Time Frame
At the day 15, 30 and at 1 and 2 years after surgery
Title
Post-operative morbidity
Description
Dindo classification of complicacions will be used
Time Frame
within the first 30 days after surgery
Title
Hemorrhoid recurrence
Description
rectal bleeding, anal pain, mucosal prolaps will be invastigated one year after hemorroidectomy. Needing of further surgery for hemorrhoids recurrence will be recorded
Time Frame
At 1 and 2 years after surgery
Title
Satisfaction after surgery
Description
A scale of 0-3 (0, not satisfied; 1 few satisfied, 2 satisfied, 3, very satisfied) will be used.
Time Frame
At the day 15, 30 and at 1 and 2 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastiano Biondo, MD, PhD
Organizational Affiliation
Bellvitge University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bellvitge University Hospital
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Rey Juan Carlos
City
Mostoles
State/Province
Madrid
ZIP/Postal Code
28933
Country
Spain
Facility Name
Hospital Comarcal de Valdeorras
City
O Barco de Valdeorras
State/Province
Ourense
ZIP/Postal Code
32300
Country
Spain
Facility Name
Galdakano Usansolo Hospital
City
Bizkaia
State/Province
Pais Vasco
ZIP/Postal Code
48960
Country
Spain
Facility Name
Hospital Universitario de la Ribera
City
Alzira
State/Province
Valencia
ZIP/Postal Code
46600
Country
Spain
Facility Name
Valle d'Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Complejo Asistencial Universitario de Leon
City
Leon
ZIP/Postal Code
24071
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Fundación Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35239526
Citation
Trenti L, Biondo S, Espin-Basany E, Barrios O, Sanchez-Garcia JL, Landaluce-Olavarria A, Bermejo-Marcos E, Garcia-Martinez MT, Alias Jimenez D, Jimenez F, Alonso A, Manso MB, Kreisler E; THDLIGA-RCT Study Group. Transanal Hemorrhoidal Dearterialization With Mucopexy Versus Vessel-Sealing Device Hemorrhoidectomy for Grade III to IV Hemorrhoids: Long-term Outcomes From the THDLIGA Randomized Controlled Trial. Dis Colon Rectum. 2023 Aug 1;66(8):e818-e825. doi: 10.1097/DCR.0000000000002272. Epub 2022 Mar 1.
Results Reference
derived
PubMed Identifier
30807456
Citation
Trenti L, Biondo S, Kreisler Moreno E, Sanchez-Garcia JL, Espin-Basany E, Landaluce-Olavarria A, Bermejo-Marcos E, Garcia-Martinez MT, Alias Jimenez D, Jimenez F, Alonso A, Manso MB; THDLIGA-RCT Study Group. Short-term Outcomes of Transanal Hemorrhoidal Dearterialization With Mucopexy Versus Vessel-Sealing Device Hemorrhoidectomy for Grade III to IV Hemorrhoids: A Prospective Randomized Multicenter Trial. Dis Colon Rectum. 2019 Aug;62(8):988-996. doi: 10.1097/DCR.0000000000001362. Erratum In: Dis Colon Rectum. 2021 Nov 1;64(11):e672.
Results Reference
derived

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Prospective Randomized Trial About THD Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids

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