The aim of this study is to investigate the feasibility and safety of a 23-hour accelerated ERAS protocol for patients undergoing colorectal surgery. In this accelerated ERAS protocol, patients undergoing colorectal surgery will be discharged within…
ID
Source
Brief title
Condition
- Other condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Health condition
Maagdarmstelselaandoening: colorectale kanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rate of the successful and safe application of the 23-hour accelerated ERAS
protocol for patients undergoing elective colorectal surgery. Success rate
(feasibility) will be measured in readmission rate and safety will be measured
with rate of serious adverse events (Clavien Dindo >=3b). Success rate
(feasibility) will also be measured in percentage of patients who were not able
to be discharged after 23 hours.
Secondary outcome
• Demographic parameters
• Disease related demographics
• Comorbidities
• Postoperative complications within 30 days
• Postoperative mortality within 30 days
• Short Nutritional Assessment Questionnaire (SNAQ)
• Groningen Frailty Index (GFI)
• Patient satisfaction evaluation
Background summary
Throughout the years, there has been a rapid change in the perioperative
protocols and procedures surrounding colorectal surgery. Upon the introduction
of the Enhanced Recovery After Surgery (ERAS) program in Western countries, an
improvement in postoperative outcomes was seen. Nowadays, researchers focus on
further improving the current standard ERAS programs enabling an accelerated
version hereof.
By improving perioperative recovery and care protocols, patients who undergo
elective colorectal surgery could potentially benefit for faster hospital
discharge without additional risk for postoperative complications.
Study objective
The aim of this study is to investigate the feasibility and safety of a 23-hour
accelerated ERAS protocol for patients undergoing colorectal surgery. In this
accelerated ERAS protocol, patients undergoing colorectal surgery will be
discharged within 23 hours after surgery.
Primary Objective:
To assess the successful and safe application of the 23-hour accelerated ERAS
protocol for patients undergoing colorectal surgery.
Secondary Objective(s):
• Postoperative outcomes, including morbidity and mortality within 30 days;
• Patient experience and satisfaction.
Study design
This study is an investigator-initiated, single-center prospective feasibility
study. This feasibility study will compare 110 consecutive patients following
the accelerated ERAS program to 110 most recent patients of a retrospective
cohort who followed the current standard ERAS 1.0 protocol in Zuyderland
Medical Center (zie document *Colorectaal Chirurgie Medisch ERAS*). A
case-matched analysis will be performed.
Intervention
Patients included in this study will follow the 23-hour accelerated ERAS
perioperative protocol which consists of a multidisciplinary approach focusing
on optimizing the pre-, intra- and postoperative procedures surrounding an
elective colorectal surgery.
This protocol for accelerated recovery and care focuses on three main
contributors: fluid management, paint control and truly minimally invasive
surgery.
Study burden and risks
A benefit of participating in this study is that this study provides an
innovative and enhanced form of perioperative care in colorectal surgery. All
procedures surrounding preoperative screening, preoperative preparing,
anesthesia, surgery and postoperative care are optimized. Providing the best
combination of circumstances for the participant. Hopefully reducing the
admission length from 4 days to 1 day. All without compromising the safety of
the patient. During the study, all participants are closely monitored and have
a dedicated staff readily accessible to any questions and possible in-hospital
evaluation.
Very few risks are associated with the participation of this study as patients
who choose to participate will not be subjected to new treatments, rather a new
protocol and order of said treatments. Participants will be closely monitored
throughout the study, and will only be discharged if deemed safe. Though the
risks are kept to a minimum, there is a small chance of the development of
postoperative complications after discharge.
Dr. H. van der Hoffplein 1
Geleen 6162 BG
NL
Dr. H. van der Hoffplein 1
Geleen 6162 BG
NL
Listed location countries
Age
Inclusion criteria
• Signed informed consent;
• Is >= 18 years <= 85;
• BMI <= 35 kg/m2;
• Is ASA III and diagnosed with (non-complicated) colorectal cancer
• Is scheduled to undergo elective laparoscopic colorectal surgery (right or
left hemicolectomy, transvers colon resection, recto-sigmoid resection with
primary anastomosis;
• Primary anastomosis is performed intracorporeally;
• Uncomplicated operation;
• Readily available ambulant care provided by an adult family member for the
first 24 hours after discharge;
• Patient is adequately reachable by phone.
Exclusion criteria
• ASA classification > 3;
• Subjects who have limited mobility and/or need to be aided/assisted when
mobilizing;
• Subjects with a history of active pulmonary infection, any other active
infection, any uncontrolled medical disease
• Subjects with a contraindication for oral NSAIDs;
• Subjects with a contraindication for spinal anesthesia;
• Subjects requiring parenteral nutrition prior to surgery;
• Subjects scheduled to undergo lower rectal resections (TaTME, APR);
• Subjects receiving an ostomy;
• Subjects who experience complications preoperatively;
• Subjects who are mentally incompetent, challenged or requiring aid with daily
life activities.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71804.096.19 |