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Completed

NCT Number: NCT02654249

Prospective Randomized Trial About 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™.

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Key information

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transanal hemorrhoidal dearterialization + mucopexy (THD).

Device

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.

Ligasure™ hemorrhoidectomy

Procedure

Excisional hemorroidectomy performed with Ligasure™

THD anoscope and doppler

Device

An dedicated anoscope with an incorporated doppler probe sold by THD Lab S.p.A will be used for the THD procedure

Ligasure Vessel Sealing

Device

A curved, small jaw, open sealer/divider sold by Covidien/medtronic will be used for the Ligasure™ hemorrhoidectomy

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

  3. Post-operative morbidity

    Time frame: within the first 30 days after surgery

    Dindo classification of complicacions will be used

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

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

Acronym: THD-LIGA

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jan 13, 2016
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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