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Mesoglycan for Pain Control After Open Excisional HAEMOrrhoidectomy

NCT04481698 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 398

Last updated 2020-07-24

No results posted yet for this study

Summary

Haemorrhoidal disease (HD) is the most common proctological disease, with a prevalence that can reach up to 39% of the population. Although I and II degree HD can be treated successfully with medical therapy or office-based procedures , excisional haemorrhoidectomy remains the gold standard technique in patients with III and IV degree HD, obtaining a much lower rate of recurrence than non-excisional methods, such as Doppler-guided haemorrhoidal artery ligation or stapled haemorrhoidopexy. However, both open and closed haemorrhoidectomies are associated with a significant rate of post-operative pain , which may be due to the incorporation of sensitive anal mucosa and fibres of the internal sphincters during the ligation of the vascular pedicle, post-operative scars, hygiene/social habits, hard stool, or oedema of the necessary mucocutaneous bridge.

Regarding the oedema/thrombosis of the mucocutaneous bridges, we strongly believe that it is the main cause of post-operative pain, and we have shown that the use of mesoglycan, a polysaccharide complex with antithrombotic and profibrinolytic properties, can reduce the rate of post-operative thrombosis and consequently post-operative pain 7-10 days after the procedures, improving patient quality of life and speeding up the recovery of daily activities.

Furthermore, its usefulness is also evident in the treatment of the acute phase of external haemorrhoidal thrombosis.

The aim of the study was to evaluate the efficacy of mesoglycan in the post-operative period of patients who underwent open excisional diathermy haemorrhoidectomy, confirming the previously obtained results

Conditions

  • Haemorrhoidal Disease
  • Post-operative Pain
  • Thrombosis

Interventions

OTHER

Mesoglycan

Prisma® 30 mg 2 vials i.m./day for the first 5 post-operative days and then Prisma® 50 mg 1 oral tablet twice/day for an additional 30 days

Sponsors & Collaborators

  • Gaetano Gallo

    collaborator UNKNOWN

  • Giuseppe Sammarco

    collaborator UNKNOWN

  • Giuseppe Clerico

    collaborator UNKNOWN

  • Alessandro Sturiale

    collaborator UNKNOWN

  • Michele Manigrasso

    collaborator UNKNOWN

  • Alberto Realis Luc

    collaborator UNKNOWN

  • Mario Trompetto

    collaborator UNKNOWN

  • Societa Italiana di Chirurgia ColoRettale

    lead NETWORK

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2017-12-01
Completion
2017-12-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04481698 on ClinicalTrials.gov