Mesoglycan for Pain Control After Open Excisional HAEMOrrhoidectomy

NCT04481698 | Completed

• 1 other identifier: 176/2017
• Study Type: observational
• Target: 398
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Changes in Post-operative Pain

  VAS

  Day 7, Day 20, Day 40

Secondary Outcomes (5)

• Changes in post-operative Thrombosis

  Day 7, Day 20, Day 40

• Changes in post-operative Bleeding

  Day 7, Day 20, Day 40

• Quality of Life (QoL)

  pre- and post-operatively 90 days after the procedure

• Changes in Surgical Wound Healing

  Day 7, Day 20, Day 40

• Changes Autonomy

  Day 7, Day 20, Day 40

Study Arms (2)

Mesoglycan

All patients received the standard post-operative therapy (a recommended oral dose of ketorolac tromethamine of 10 mg every 4-6 hours, not exceeding 40 mg per day and not exceeding 5 post-operative days according to the indications for short-term management of moderate/severe acute post-operative pain and stool softeners) plus 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, Mediolanum Farmaceutici, Milan, Italy)

Other: Mesoglycan

Control

standard post-operative therapy (a recommended oral dose of ketorolac tromethamine of 10 mg every 4-6 hours, not exceeding 40 mg per day and not exceeding 5 post-operative days according to the indications for short-term management of moderate/severe acute post-operative pain and stool softeners)

Other: Mesoglycan

Interventions

Mesoglycan OTHER

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

Control; Mesoglycan

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients received the standard post-operative therapy (a recommended oral dose of ketorolac tromethamine of 10 mg every 4-6 hours, not exceeding 40 mg per day and not exceeding 5 post-operative days according to the indications for short-term management of moderate/severe acute post-operative pain and stool softeners) plus 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, Mediolanum Farmaceutici, Milan, Italy).

You may qualify if:

• III and IV degree Hemorrhoidal Disease
• Age \> 18
• Written Informed Consent

You may not qualify if:

• Age \<18
• Past or present history of:
• Coagulopathy
• Cardiac Diseases
• Anticoagulant Therapies
• Colorectal or Anal Neoplasms
• Inflammatory Bowel Disease
• Pelvic Radiotherapy
• Anal Surgery
• Allergy to Mesoglycan
• Inability to return for post-operative control visits

Sponsors & Collaborators

• Societa Italiana di Chirurgia ColoRettale: lead
• Gaetano Gallo: collaborator
• Giuseppe Sammarco: collaborator
• Giuseppe Clerico: collaborator
• Alessandro Sturiale: collaborator
• Michele Manigrasso: collaborator
• Alberto Realis Luc: collaborator
• Mario Trompetto: collaborator

Study Sites (1)

University of Catanzaro

Catanzaro, 88100, Italy

Location

Related Publications (5)

• Gallo G, Martellucci J, Sturiale A, Clerico G, Milito G, Marino F, Cocorullo G, Giordano P, Mistrangelo M, Trompetto M. Consensus statement of the Italian society of colorectal surgery (SICCR): management and treatment of hemorrhoidal disease. Tech Coloproctol. 2020 Feb;24(2):145-164. doi: 10.1007/s10151-020-02149-1. Epub 2020 Jan 28.

  PMID: 31993837 RESULT

• Cocorullo G, Tutino R, Falco N, Licari L, Orlando G, Fontana T, Raspanti C, Salamone G, Scerrino G, Gallo G, Trompetto M, Gulotta G. The non-surgical management for hemorrhoidal disease. A systematic review. G Chir. 2017 Jan-Feb;38(1):5-14. doi: 10.11138/gchir/2017.38.1.005.

  PMID: 28460197 RESULT

• Simillis C, Thoukididou SN, Slesser AA, Rasheed S, Tan E, Tekkis PP. Systematic review and network meta-analysis comparing clinical outcomes and effectiveness of surgical treatments for haemorrhoids. Br J Surg. 2015 Dec;102(13):1603-18. doi: 10.1002/bjs.9913. Epub 2015 Sep 30.

  PMID: 26420725 RESULT

• Gallo G, Mistrangelo M, Passera R, Testa V, Pozzo M, Perinotti R, Lanati I, Lazzari I, Tonello P, Ugliono E, De Luca E, Realis Luc A, Clerico G, Trompetto M. Efficacy of Mesoglycan in Pain Control after Excisional Hemorrhoidectomy: A Pilot Comparative Prospective Multicenter Study. Gastroenterol Res Pract. 2018 Mar 19;2018:6423895. doi: 10.1155/2018/6423895. eCollection 2018.

  PMID: 29743886 RESULT

• Bessa SS. Diathermy excisional hemorrhoidectomy: a prospective randomized study comparing pedicle ligation and pedicle coagulation. Dis Colon Rectum. 2011 Nov;54(11):1405-11. doi: 10.1097/DCR.0b013e318222b5a9.

  PMID: 21979186 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Thrombosis

Interventions

mesoglycan

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 22, 2020
• Study Start: April 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IT (1)