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

• ClinicalTrials.gov Identifier: NCT02654249
• Recruitment Status: Unknown
• First Posted: January 13, 2016
• Last Update Posted: December 7, 2017
• Sponsor: Hospital Universitari de Bellvitge
• Information provided by (Responsible Party): Sebastiano Biondo, Hospital Universitari de Bellvitge

Tracking Information

• First Submitted Date: December 13, 2015
• First Posted Date: January 13, 2016
• Last Update Posted Date: December 7, 2017
• Actual Study Start Date: December 2015
• Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 11, 2016)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 30, 2017)

• 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.

Original Secondary Outcome Measures (submitted: January 11, 2016)

• Quality of life [ Time Frame: At 1 month and at 1 year 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 year 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 year 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 year after surgery ]
  A scale of 0-3 (0, not satisfied; 1 few satisfied, 2 satisfied, 3, very satisfied) will be used.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prospective Randomized Trial About THD Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids
• Official Title: Prospective Multicenter Randomized Trial About Transanal Hemorrhoidal Dearterialization With Mucopexy (THD) Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hemorrhoids

Intervention

• 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.
• Procedure: Ligasure™ hemorrhoidectomy
  Excisional hemorroidectomy performed with Ligasure™
• 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
• Device: Ligasure Vessel Sealing
  A curved, small jaw, open sealer/divider sold by Covidien/medtronic will be used for the Ligasure™ hemorrhoidectomy

Study Arms

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

  • Device: Transanal hemorrhoidal dearterialization + mucopexy (THD).
  • Device: THD anoscope and doppler
• Active Comparator: Ligasure hemorroidectomy
  Patients will undergo to Ligasure™ hemorroidectomy under generla anesthesia.
  Interventions:

  • Procedure: Ligasure™ hemorrhoidectomy
  • Device: Ligasure Vessel Sealing

• Publications *: Trenti L, Biondo S, Kreisler Moreno E, Sanchez-Garcia JL, Espin-Basany E, Landaluce-Olavarria A, Bermejo-Marcos E, Garcia-Martinez MT, Alías Jiménez 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: January 11, 2016): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2019
• Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 76 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT02654249
• Other Study ID Numbers: THD_LIGA_RCT
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sebastiano Biondo, Hospital Universitari de Bellvitge
• Study Sponsor: Hospital Universitari de Bellvitge
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sebastiano Biondo, MD, PhD; Bellvitge University Hospital

• PRS Account: Hospital Universitari de Bellvitge
• Verification Date: December 2017