Haemorrhoidal DiseaseMeHAEMONCT04481698
Mesoglycan for Pain Control After Open Excisional HAEMOrrhoidectomy
An observational study of Haemorrhoidal Disease and Post-operative Pain, run by Societa Italiana di Chirurgia ColoRettale at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Haemorrhoidal Disease, Post-operative Pain, Thrombosis
- What is being tested?
- Mesoglycan
- Type of treatment
- Pill or oral medicine
- How many people
- 398 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2017to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
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).
Who may be able to join
- III and IV degree Hemorrhoidal Disease
- Age > 18
- Written Informed Consent
Who cannot join
- Age <18
- Past or present history of:
- Coagulopathy
- Cardiac Diseases
- Anticoagulant Therapies
- Colorectal or Anal Neoplasms
Show all 11Show fewer
- Inflammatory Bowel Disease
- Pelvic Radiotherapy
- Anal Surgery
- Allergy to Mesoglycan
- Inability to return for post-operative control visits
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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
Read the detailed description
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.
- Conditions
- Haemorrhoidal Disease, Post-operative Pain, Thrombosis
- Being tested
- Mesoglycan
- Medical subject headings
- Pain, Postoperative, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesoglycanOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Mesoglycan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Post-operative Pain
VAS
Measured: Day 7, Day 20, Day 40
Secondary outcomes (5)
Changes in post-operative Thrombosis
Dichotomous parameter (Yes or Not)
Measured: Day 7, Day 20, Day 40
Changes in post-operative Bleeding
Dichotomous parameter (Yes or Not)
Measured: Day 7, Day 20, Day 40
Quality of Life (QoL)
We used the 12-Item Short Form Survey (SF-12) to assess QoL
Measured: pre- and post-operatively 90 days after the procedure
Changes in Surgical Wound Healing
we evaluated wound healing with the following scale: infected, granulating, healed
Measured: Day 7, Day 20, Day 40
Changes Autonomy
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)
Measured: Day 7, Day 20, Day 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Apr 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Haemorrhoidal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettale
- Sponsor type
- Research network
- Collaborators
- Gaetano Gallo, Giuseppe Sammarco, Giuseppe Clerico, Alessandro Sturiale, Michele Manigrasso, Alberto Realis Luc, Mario Trompetto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481698
- Sponsor's protocol ID
- 176/2017
- Acronym
- MeHAEMO
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 31993837Cocorullo 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.
PubMed 28460197Simillis 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.
PubMed 26420725Gallo 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.
PubMed 29743886Bessa 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.
PubMed 21979186
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04481698
- Acronym / sponsor ID
- MeHAEMO / 176/2017
- Conditions
- Haemorrhoidal Disease, Post-operative Pain, Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettaleResearch network
- Collaborators
- Gaetano Gallo, Giuseppe Sammarco, Giuseppe Clerico, Alessandro Sturiale, Michele Manigrasso, Alberto Realis Luc, Mario Trompetto
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesoglycan | – | Other: MesoglycanAll 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) |
| Control | – | Other: Mesoglycanstandard 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) |
Who may qualify
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- III and IV degree Hemorrhoidal Disease
- Age > 18
- Written Informed Consent
Key exclusion criteria (11 listed)
- Age <18
- Past or present history of:
- Coagulopathy
- Cardiac Diseases
- Anticoagulant Therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MesoglycanPrisma® 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 | Other | Control, Mesoglycan |
Primary outcome
Changes in Post-operative Pain
Time frame: Day 7, Day 20, Day 40
VAS
5 secondary outcomes
Changes in post-operative Thrombosis
Time frame: Day 7, Day 20, Day 40
Changes in post-operative Bleeding
Time frame: Day 7, Day 20, Day 40
Quality of Life (QoL)
Time frame: pre- and post-operatively 90 days after the procedure
Changes in Surgical Wound Healing
Time frame: Day 7, Day 20, Day 40
Changes Autonomy
Time frame: Day 7, Day 20, Day 40
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Results publication: PubMed 31993837Gallo 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.
- Results publication: PubMed 28460197Cocorullo 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.
- Results publication: PubMed 26420725Simillis 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.
- Results publication: PubMed 29743886Gallo 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.
- Results publication: PubMed 21979186Bessa 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemorrhoidal Disease and Post-operative Pain, run by Societa Italiana di Chirurgia ColoRettale at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Post-operative Pain (time frame: Day 7, Day 20, Day 40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04481698, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.