The aim of this study is to investigate the feasibility and safety of an accelerated protocol for patients undergoing liver surgery compared to a retrospective cohort of patients who followed the standard ERAS care for liver surgery. In this…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rate of the successful and safe application of the accelerated recovery
protocol for patients undergoing elective liver surgery. Success rate
(feasibility) will be measured in length of hospital stay (LOS). Success is
defined as discharge on POD1 after a minor liver resection and on POD2-3 after
major liver resection discharge. Safety will be measured with rate of
readmission and serious adverse events (Clavien Dindo >=3b) within 90 days
postoperatively.
Secondary outcome
• Postoperative complications within 90 days
• Postoperative mortality within 90 days
• Difference between achievement of functional recovery and actual discharge
date
• Patient satisfaction evaluation form
• Demographic parameters
• Disease related demographics
• Comorbidities
Background summary
Throughout the years, there has been a rapid change in the perioperative
protocols and procedures surrounding liver 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.
Study objective
The aim of this study is to investigate the feasibility and safety of an
accelerated protocol for patients undergoing liver surgery compared to a
retrospective cohort of patients who followed the standard ERAS care for liver
surgery. In this protocol, patients undergoing liver surgery will be discharged
within respectively 24 (minor liver resection) or 48-72 hours (major liver
resection) after surgery.
Study design
This study is an investigator-initiated, multi-center prospective study. This
feasibility study will compare 20 patients undergoing minor or major liver
resections, whether or not combined with ablation, and treated according to the
CHASE program with 20 patients of a retrospective cohort who followed the
current standard ERAS protocol in the Maastricht University Medical Center+
(MUMC+). Patients will be screened, recruited and enrolled at Zuyderland
Medical Center en MUMC+.
Intervention
Patients in this study will follow the CHASE protocol, which consists of a
multidisciplinary approach aimed at optimizing the pre-, intra- and
post-operative procedures surrounding elective liver surgery.
This accelerated recovery protocol focuses on three main factors: infusion
management, pain management and truly minimally invasive surgery.
Study burden and risks
Patients included in this study will be guided and thoroughly informed about
the procedures pertaining to CHASE. All procedures and protocols are divided in
the preoperative phase, the perioperative phase and the postoperative phase.
Other than an evaluation form (1x); provision of a limited array of pain
medication; faster postoperative feeding and mobilization, included patients
are not subjected to a greater burden when compared to standard protocol.
Included patients are requested to arrange postoperative ambulant care for the
first 24-hours after discharge. Potential pain and discomfort associated with
surgery is not expected to be worse than in patients who are treated according
to the standard ERAS protocol.
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;
- ASA I-III;
- Diagnosed with liver malignancy;
- Is scheduled to undergo elective laparoscopic liver resection, whether or not
combined with ablation
- Readily available ambulant care provided by an adult family member for the
first 24 hours after discharge;
- Proficient in Dutch language and writing;
- Patient is adequately reachable by phone.
Exclusion criteria
- ASA classification > 3;
- Subjects undergoing rehepatectomy
- 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 (any form of) liver cirrhosis
- Subjects with a contraindication for oral NSAIDs;
- Subjects with a contraindication for spinal anesthesia;
- Subjects requiring parenteral nutrition prior to surgery;
- Subjects receiving an ostomy;
- Subjects who experience complications preoperatively;
- Subjects who are mentally incompetent, challenged or requiring aid with daily
life activities.
Design
Recruitment
Medical products/devices used
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 | NL86745.096.24 |