Mesoglycan for Pain Control After Open Excisional HAEMOrrhoidectomy (MeHAEMO)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04481698 |
|
Recruitment Status :
Completed
First Posted : July 22, 2020
Last Update Posted : July 24, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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
| Condition or disease | Intervention/treatment |
|---|---|
| Haemorrhoidal Disease Post-operative Pain Thrombosis | Other: Mesoglycan |
This was a retrospective multicentre study and is reported according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement for cohort studies
Between September and December 2017, 206 patients with III and IV degree HD, according to Goligher classification, from sixteen colorectal referral centres belonging to SICCR (Società Italiana di Chirurgia Colorettale), who satisfied inclusion criteria underwent open excision haemorrhoidectomy.
The results obtained were compared with a homogeneous sample of 192 patients who underwent OEH in the same centres between April and July 2017 and who had received standard post-operative therapy without 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).
In each referral centre, the procedures were carried out by an experienced surgeon who had performed more than 200 haemorrhoidectomies.
A clinical external examination was performed the first post-operative day, and an anorectal digital evaluation with proctoscopy was performed at T2, T3 and T4.
During each follow-up visit, post-operative pain was evaluated at rest, after defecation and after anorectal digital examination using a visual analogue scale (minimum score = 0; maximum score = 10).
Quality of life was evaluated pre- and post-operatively 90 days after the procedure using the SF-12 questionnaire.
Polypharmacy was defined as 5 or more medications daily. Thrombosis was defined as one or more swollen painful piles at the site of the mucocutaneous bridge and was assessed at T2, T3 and T4.
Surgical wound healing (granulation) was evaluated at T2, T3 and T4 using the following 3 items: infected, granulating, healed.
Autonomy was evaluated at T2, T3 and T4 using the following 4 items: complete inactivity, total autonomy at home, ability to drive, return to normal activities (autonomy at home, driving, working).
Bowel movements were evaluated, according to the proper guidelines, at T2, T3 and T4, and patients were classified in three categories: regular, constipation or diarrhoea.
| Study Type : | Observational |
| Actual Enrollment : | 398 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| Official Title: | Mesoglycan for Pain Control After Open Excisional HAEMOrrhoidectomy (MeHAEMO): An Observational Multicentre Study on Behalf of the Italian Society of Colorectal Surgery (SICCR) |
| Actual Study Start Date : | April 1, 2017 |
| Actual Primary Completion Date : | December 1, 2017 |
| Actual Study Completion Date : | December 1, 2017 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
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
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
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 |
- Changes in Post-operative Pain [ Time Frame: Day 7, Day 20, Day 40 ]VAS
- Changes in post-operative Thrombosis [ Time Frame: Day 7, Day 20, Day 40 ]Dichotomous parameter (Yes or Not)
- Changes in post-operative Bleeding [ Time Frame: Day 7, Day 20, Day 40 ]Dichotomous parameter (Yes or Not)
- Quality of Life (QoL) [ Time Frame: pre- and post-operatively 90 days after the procedure ]We used the 12-Item Short Form Survey (SF-12) to assess QoL
- Changes in Surgical Wound Healing [ Time Frame: Day 7, Day 20, Day 40 ]we evaluated wound healing with the following scale: infected, granulating, healed
- Changes Autonomy [ Time Frame: Day 7, Day 20, Day 40 ]we evaluated autonomy with the following parameters: complete inactivity (patient unable to performing any activity), total autonomy at home, ability to drive, return to normal activities (patient able to performing any activity)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- III and IV degree Hemorrhoidal Disease
- Age > 18
- Written Informed Consent
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04481698
| Italy | |
| University of Catanzaro | |
| Catanzaro, Italy, 88100 | |
| Responsible Party: | Societa Italiana di Chirurgia ColoRettale |
| ClinicalTrials.gov Identifier: | NCT04481698 |
| Other Study ID Numbers: |
176/2017 |
| First Posted: | July 22, 2020 Key Record Dates |
| Last Update Posted: | July 24, 2020 |
| Last Verified: | July 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Thrombosis Pain, Postoperative Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Postoperative Complications Pathologic Processes Pain Neurologic Manifestations |