Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04799379
Status:
COMPLETED
Last Update Posted:
2021-12-29
First Post:
2021-02-26
Brief Title:
Microporous Polysaccharide Hemospheres MPH Improving Outcome After Rectal Surgery
Sponsor:
Grupo Español de Rehabilitación Multimodal
Organization:
Grupo Español de Rehabilitación Multimodal
Study Overview
Official Title:
Evaluation of Microporous Polysaccharide Hemospheres MPH Agent in Preventing Postoperative Complications After Rectal Surgery EPHAS Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
RECRUITING
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:
EPHAS
Brief Summary:
Multi-center prospective cohort study of patients scheduled for elective rectal surgery who received absorbable hemostatic powder to assess whether it can improve patient postoperative outcomes reduce usage of drains and prove to be cost-effective This cohort will be compared to a previously studied cohort using drains Power and IMPRICA study with comparable patient characteristics
The primary endpoint of the study is postoperative pelvic sepsis within 60 postoperative days including anastomotic leakage pelvic abscess and peritonitis
Secondary endpoints postoperative morbidities rate of reoperation and length of hospitalization
The primary endpoint of the study is postoperative pelvic sepsis within 60 postoperative days including anastomotic leakage pelvic abscess and peritonitis
Secondary endpoints postoperative morbidities rate of reoperation and length of hospitalization
Detailed Description:
Multimodal surgical rehabilitation also known as Enhanced Recovery After Surgery entails the application of a series of perioperative procedure measures and strategies aimed at patients who are going to undergo a surgical procedure with the objective of reducing secondary stress caused by the surgical intervention and thus achieve enhanced recovery of the patient and decrease complications and mortality
ERAS protocols are care programs based on scientific evidence encompassing all aspects of patient care and requiring multidisciplinary management with the participation of diverse specialists1 Starting at the diagnosis their aim is to recognize patients individual needs to optimize their treatment before during and after surgery The close collaboration of all specialists participating in the process as well as of the actual patients and their relatives has proved to be essential
The Multimodal Rehabilitation Programmes MRP or Enhanced Recovery Programmes ERAS review traditional perioperative procedure practices evaluating the specific key points of each type of surgery and analysing their scientific evidence MRPs have shown in cents that have routinely adopted them a significant improvement in the patients quality of life Furthermore MRPs significantly reducing the hospital stay and potential complications associated with hospitalisation2 being the anastomotic leak AL the most serious of them
Total mesorectal excision TME and bowel restoration is currently the standard treatment for middle to low rectal cancer However TME has been shown to be associated with high anastomotic leakage with a reported incidence of up to 24 reaching 50 when clinically silent radiographic leaks are considered3
Despite a large number of studies in the literature that have investigated risk factors the fundamental causes of AL remain unclear In this sense according to enhanced recovery after surgery ERAS protocols4 pelvic drain should not be used routinely as it may cause patient discomfort and prolong hospitalization Moreover drain itself is also a potential site of infection especially if open or passive drainage system is used
Even based in the best available evidence ERAS protocols have important implementation problems because they have to put up with traditional attitudes In this sense many surgeons still advocate the use of a prophylactic pelvic drain because they believe that fluid collection in the pelvis could be a potential source of contamination and thereby weakening anastomotic integrity and healing
In a recent study from the Spanish group GERM2 avoidance of drains was achieved only in 347 of patients undergoing elective colorectal surgery ERAS centres had a greater avoidance of drains vs non-ERAS centres 386 vs 283 although most patients still received drains More relevant avoidance of drainage was associated with a significant reduction in moderate to severe complications
We believe that it is more than justified to try new options that help surgeons reduce the use of drains One of these is the use of hemostatic agents Some topical hemostats may theoretically be of benefit due to its claimed lymphostatic properties
Published data for this is sparse but some studies have shown statistically significant reduction of fluid collection after using AristaAH5
Arista is a plant-based flowable powder engineered to rapidly dehydrate blood enhancing clotting on contact Arista facilitates the formation of a highly resilient natural clot within just a few minutes regardless of the patients coagulation status Arista is fully absorbable within 24 to 48 hours of application and because Arista degrades rapidly it does not promote infection
This study has been designed to support the working hypothesis that Arista placed intraoperatively into the dissected pelvic area could reduce sepsis and postoperative anastomotic leakage We choose to study Arista for a theoretical reason it contains microporous polysaccharide hemospheres MPHs MPHs not only activate the coagulation cascade but they cause tissue desiccation which presumably seals capillaries and could theoretically also seal small lymph vessels left open by electrosurgical devices
Study assumptions Arista spread on the pelvic floor at the end of surgery may allow to
1 close small holes and prevent fluid from penetrating into the pelvic floor thereby avoiding AL
2 facilitate the avoidance of drains
ERAS protocols are care programs based on scientific evidence encompassing all aspects of patient care and requiring multidisciplinary management with the participation of diverse specialists1 Starting at the diagnosis their aim is to recognize patients individual needs to optimize their treatment before during and after surgery The close collaboration of all specialists participating in the process as well as of the actual patients and their relatives has proved to be essential
The Multimodal Rehabilitation Programmes MRP or Enhanced Recovery Programmes ERAS review traditional perioperative procedure practices evaluating the specific key points of each type of surgery and analysing their scientific evidence MRPs have shown in cents that have routinely adopted them a significant improvement in the patients quality of life Furthermore MRPs significantly reducing the hospital stay and potential complications associated with hospitalisation2 being the anastomotic leak AL the most serious of them
Total mesorectal excision TME and bowel restoration is currently the standard treatment for middle to low rectal cancer However TME has been shown to be associated with high anastomotic leakage with a reported incidence of up to 24 reaching 50 when clinically silent radiographic leaks are considered3
Despite a large number of studies in the literature that have investigated risk factors the fundamental causes of AL remain unclear In this sense according to enhanced recovery after surgery ERAS protocols4 pelvic drain should not be used routinely as it may cause patient discomfort and prolong hospitalization Moreover drain itself is also a potential site of infection especially if open or passive drainage system is used
Even based in the best available evidence ERAS protocols have important implementation problems because they have to put up with traditional attitudes In this sense many surgeons still advocate the use of a prophylactic pelvic drain because they believe that fluid collection in the pelvis could be a potential source of contamination and thereby weakening anastomotic integrity and healing
In a recent study from the Spanish group GERM2 avoidance of drains was achieved only in 347 of patients undergoing elective colorectal surgery ERAS centres had a greater avoidance of drains vs non-ERAS centres 386 vs 283 although most patients still received drains More relevant avoidance of drainage was associated with a significant reduction in moderate to severe complications
We believe that it is more than justified to try new options that help surgeons reduce the use of drains One of these is the use of hemostatic agents Some topical hemostats may theoretically be of benefit due to its claimed lymphostatic properties
Published data for this is sparse but some studies have shown statistically significant reduction of fluid collection after using AristaAH5
Arista is a plant-based flowable powder engineered to rapidly dehydrate blood enhancing clotting on contact Arista facilitates the formation of a highly resilient natural clot within just a few minutes regardless of the patients coagulation status Arista is fully absorbable within 24 to 48 hours of application and because Arista degrades rapidly it does not promote infection
This study has been designed to support the working hypothesis that Arista placed intraoperatively into the dissected pelvic area could reduce sepsis and postoperative anastomotic leakage We choose to study Arista for a theoretical reason it contains microporous polysaccharide hemospheres MPHs MPHs not only activate the coagulation cascade but they cause tissue desiccation which presumably seals capillaries and could theoretically also seal small lymph vessels left open by electrosurgical devices
Study assumptions Arista spread on the pelvic floor at the end of surgery may allow to
1 close small holes and prevent fluid from penetrating into the pelvic floor thereby avoiding AL
2 facilitate the avoidance of drains
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