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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Summary:

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.


Sponsor: Hospital Universitari de Bellvitge

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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:

  • 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.


Information By: Hospital Universitari de Bellvitge

Dates:
Date Received: December 13, 2015
Date Started: December 2015
Date Completion: September 2019
Last Updated: March 30, 2017
Last Verified: March 2017