NCT04481698: MeHAEMO

Mesoglycan for Pain Control After Open Excisional HAEMOrrhoidectomy

Completed Last updated 24 July 2020

What this trial tests

trial testing Mesoglycan in Haemorrhoidal Disease in 398 participants. Completed in 1 December 2017.

Timeline

1 April 2017

Primary endpoint
1 December 2017

1 December 2017

Quick facts

Lead sponsor	Societa Italiana di Chirurgia ColoRettale
Status	Completed
Study type	OBSERVATIONAL
Enrollment	398
Start date	1 April 2017
Primary completion	1 December 2017
Estimated completion	1 December 2017
Sites	1 location across Italy

Drugs / interventions tested

• Mesoglycan

Conditions studied

• Haemorrhoidal Disease — all drugs for Haemorrhoidal Disease →
• Post-operative Pain — all drugs for Post-operative Pain →
• Thrombosis — all drugs for Thrombosis →

Sponsor

Societa Italiana di Chirurgia ColoRettale — full company profile →

Who can join

Eligibility, any sex, with Haemorrhoidal Disease or Post-operative Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Heterologous production of chondroitin.
   Couto MR, Rodrigues JL, Rodrigues LR. · · 2022 · cited 8× · PMID 35242620 · DOI 10.1016/j.btre.2022.e00710
2. Mesoglycan for pain control after open excisional HAEMOrrhoidectomy (MeHAEMO): an observational multicentre study on behalf of the Italian Society of Colorectal Surgery (SICCR).
   Gallo G, Di Saverio S, Clerico G, Sturiale A, et al · · 2020 · cited 8× · PMID 33092570 · DOI 10.1186/s12893-020-00914-5