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 patient's
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
34.7% of patients undergoing elective colorectal surgery. ERAS centres had a greater
avoidance of drains vs non-ERAS centres (38.6% vs 28.3%), 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 Arista®AH5.
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 patient's 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
close small holes and prevent fluid from penetrating into the pelvic floor, thereby
avoiding AL
facilitate the avoidance of drains