Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04481698
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2020-07-14
Brief Title:
Mesoglycan for Pain Control After Open Excisional HAEMOrrhoidectomy
Sponsor:
Societa Italiana di Chirurgia ColoRettale
Organization:
Societa Italiana di Chirurgia ColoRettale
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MeHAEMO
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 hygienesocial habits hard stool or oedema of the necessary mucocutaneous bridge
Regarding the oedemathrombosis 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
Regarding the oedemathrombosis 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 moderatesevere acute post-operative pain and stool softeners plus mesoglycan Prisma 30 mg 2 vials imday for the first 5 post-operative days and then Prisma 50 mg 1 oral tablet twiceday 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
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 moderatesevere acute post-operative pain and stool softeners plus mesoglycan Prisma 30 mg 2 vials imday for the first 5 post-operative days and then Prisma 50 mg 1 oral tablet twiceday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None