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

This study is currently recruiting participants.
Verified March 2017 by Sebastiano Biondo, Hospital Universitari de Bellvitge
Sponsor:
ClinicalTrials.gov Identifier:
NCT02654249
First Posted: January 13, 2016
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sebastiano Biondo, Hospital Universitari de Bellvitge
  Purpose
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™.

Condition Intervention
Hemorrhoids Device: Transanal hemorrhoidal dearterialization + mucopexy (THD). Procedure: Ligasure™ hemorrhoidectomy Device: THD anoscope and doppler Device: Ligasure Vessel Sealing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Multicenter Randomized Trial About Transanal Hemorrhoidal Dearterialization With Mucopexy (THD) Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids

Resource links provided by NLM:


Further study details as provided by Sebastiano Biondo, Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

  • 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.

  • Post-operative morbidity [ Time Frame: within the first 30 days after surgery ]
    Dindo classification of complicacions will be used

  • 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

  • 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.


Estimated Enrollment: 80
Study Start Date: December 2015
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654249


Contacts
Contact: Sebastiano Biondo, MD, PhD +34-932607485 sbn.biondo@gmail.com
Contact: Loris Trenti, MD +34-932607485 loris.trenti@bellvitgehospital.cat

Locations
Spain
Bellvitge University Hospital Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Sebastiano Biondo, MD, PhD    +34 932607485    sbn.biondo@gmail.com   
Contact: Loris Trenti, MD    +34 932607485    loris.trenti@bellvitgehospital.cat   
Sub-Investigator: Loris Trenti, MD, PhD         
Sub-Investigator: Jordi Miquel Escarra, MD         
Sub-Investigator: Resurreccion Sanzol Berruezo, MD         
Sub-Investigator: Esther Kreisler Moreno, MD, PhD         
Hospital Universitario Rey Juan Carlos Recruiting
Mostoles, Madrid, Spain, 28933
Contact: David Alis Jimenez, MD       david.alias@hospitalreyjuancarlos.es   
Hospital Comarcal de Valdeorras Recruiting
O Barco de Valdeorras, Ourense, Spain, 32300
Contact: Maite Teresa Garcia Martinez, MD    +34651739886    teresa_garcia_martinez@yahoo.es   
Galdakano Usansolo Hospital Recruiting
Bizkaia, Pais Vasco, Spain, 48960
Contact: Aitor Landaluce Olavarria, MD    +34 944007000    aitorlandaluce@outlook.com   
Hospital Universitario de la Ribera Not yet recruiting
Alzira, Valencia, Spain, 46600
Contact: FRANCISCO JAVIER BLANCO GONZÁLEZ, MD    962 45 81 00    franciscojavierblancosurg@gmail.com   
Valle d'Hebron University Hospital Recruiting
Barcelona, Spain, 08035
Contact: Jose Luis Sanchez, MD    +34 934 89 31 00    30208jsg@comb.cat   
Complejo Asistencial Universitario de Leon Not yet recruiting
Leon, Spain, 24071
Contact: Tomas Elosua Gonzalez, MD    987237400    tomasgelosua@gmail.com   
Hospital Universitario de La Princesa Recruiting
Madrid, Spain, 28006
Contact: Elena Bermejo Marcos, MD    915202200    ebermar@gmail.com   
Fundación Jimenez Diaz Not yet recruiting
Madrid, Spain, 28040
Contact: Mario Ortega, MD    915504800    ortegalopezmario@gmail.com   
Hospital La Paz Recruiting
Madrid, Spain, 28046
Contact: Jose Marijuan Martin, MD    917277000    jlmarijuan.hospital@gmail.com   
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Investigators
Principal Investigator: Sebastiano Biondo, MD, PhD Bellvitge University Hospital
  More Information

Responsible Party: Sebastiano Biondo, MD, PhD, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT02654249     History of Changes
Other Study ID Numbers: THD_LIGA_RCT
First Submitted: December 13, 2015
First Posted: January 13, 2016
Last Update Posted: April 4, 2017
Last Verified: March 2017

Keywords provided by Sebastiano Biondo, Hospital Universitari de Bellvitge:
Hemorrhoids grade III and IV
transanal hemorrhoidal dearterialization
hemorroidectomy
THD
LigaSure

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases