The aim of this study is to investigate the amount of clinically relevant SRML (defined in this study as *5% muscle loss within one week measured by the cross sectional area (CSA) of the different muscles) in patients after major abdominal surgery…
ID
Source
Brief title
Condition
- Other condition
- Miscellaneous and site unspecified neoplasms benign
- Gastrointestinal therapeutic procedures
Synonym
Health condition
chirurgisch gerelateerd spierverlies
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our main objective is to measure the amount of clinically relevant SRML
(defined as *5% muscle loss within one week measured by the CSA of the
different muscles) in cancer patients after major abdominal surgery for
pseudomyxoma peritonei, pancreatic, liver and colorectal cancer by using
bedside ultrasound and squeeze and force measurements of arms and legs.
Secondary outcome
For the different secondary endpoints the included group of patients will be
divided in two subgroups:
* Clinically relevant SRML (*5% muscle loss within seven days) and
* Clinically not relevant SRML (< 5% muscle loss within seven days)
Our secondary objectives will be the difference - within our two subgroups -
between :
1. Mean SRML per day (during hospital stay);
2. Mean loss of muscle strength per day (during hospital stay);
3. SRML patterns over 10 days;
4. Identifying whether the following points are risk factors for clinically
relevant SRML;
a. Age * 65 years
b. Sarcopenia measured preoperatively by CT scan (exact definition and
measurement method described in chapter 9.3.5.3)
c. Diabetes preoperatively
d. Major postoperative complications (Clavien-Dindo * III)
e. Insufficient physical activity: <150 minutes moderate or vigorous intensity
physical activity during the first seven days after surgery
f. Insufficient protein intake: intake of protein less than 1.5 gram per
kilogram per day during two or more days within the first week after surgery
5. Correlation of urinary creatinine excretion rate (CER);
6. Unplanned readmissions to the hospital within 30 days after discharge;
7. The influence on quality of life and fatigue after three and six months
Background summary
Acute muscle loss in critically ill patients is associated with significant
morbidity and mortality and predictive of long-term functional disability. Up
to now, only three studies examined acute Surgery Related Muscle Loss (SRML) in
surgical cancer patients. At least one out of three cancer patients will have
*10% muscle loss within one week after major abdominal surgery. There is no
global consensus about which amount of muscle loss is clinically relevant
(e.g. harmful for the patient). Definitions in scientific publications vary
from *2.7 to *10% loss of muscle mass within one week after surgery. SRML seems
to be associated with several short-term postoperative outcomes and negatively
affects Quality of Life (QoL) and fatigue postoperatively. At this moment only
two risk factors for SRML have been identified (age *65 years and diabetes
preoperatively).
Study objective
The aim of this study is to investigate the amount of clinically relevant SRML
(defined in this study as *5% muscle loss within one week measured by the cross
sectional area (CSA) of the different muscles) in patients after major
abdominal surgery for pseudomyxoma peritonei, pancreatic, liver and colorectal
cancer by using bedside ultrasound and squeeze and force measurements of arms
and legs. At the same time, possible risk factors for clinically relevant SRML
will be analyzed and correlated to the effect of clinically relevant SRML on
fatigue and QoL after three and six months.
Study design
We will conduct an observational cohort study in the UMCG including the
surgical oncology and hepatic pancreatic biliary surgery departments. The study
will run from December 2018 until December 2020 and 180 patients will be
included. After informed consent is given, the patient will be included into
the study. One day before surgery the patient will undergo a series of tests
consisting of: two quality of life questionnaires (The World Health
Organization Quality of Life (WHOQOL-Bref) and RAND 36-item Health Survey
(RAND-36)) and a fatigue questionnaire (Multidimensional Fatigue Inventory,
MFI-20), squeeze and force measurements of arms and legs to determine muscle
strength, 24-hour urine collection to determine the urinary creatinine
excretion rate and ultrasound measurements of four muscles (m. biceps brachii,
m. rectus abdominis, m. rectus femoris and m. vastus intermedius) to estimate
baseline muscle mass by measuring the CSA. The ultrasound and squeeze and force
measurements will be repeated on the 3th, 7th and 10th day after surgery and on
the day of discharge. During hospital stay physical activity of each patient
will be monitored by using an activity tracker attached to the ankle of the
patient. Also protein intake during hospital stay will be monitored every day
by a dietician. Three and six months after hospital discharge, the patient will
be seen in the outpatient clinic to repeat the quality of life and fatigue
questionnaires. Basic patient, operation and postoperative characteristics will
be collected from digital patient records.
Six possible risk factors for clinically relevant SRML were previously
identified by literature or expert opinion, consisting of: sarcopenia
preoperatively, diabetes preoperatively, age *65 years, major postoperative
complications (Clavien-Dindo * III), insufficient physical activity and
insufficient protein intake. Three possible risk factors (age, diabetes
preoperatively, and major postoperative complications) will be collected from
digital patient records. The presence of sarcopenia preoperatively will be
measured on preoperative workup CT scans by a musculoskeletal radiologist
according to the latest guidelines. Physical activity during hospital stay will
be monitored by an activity tracker. Insufficient physical activity is defined
according to the Dutch movement guideline for the health council: less than 150
minutes of moderate/vigorous intensity physical activity (<2020 counts/min) per
seven days. Protein intake per day is calculated by a dietician. According to
the European Society for Clinical Nutrition and Metabolism guidelines surgical
patients need 1.5 gram/kilogram protein per day after major surgery.
Insufficient protein intake is defined as an intake less than 1.5
gram/kilogram/day during two or more days within the first week after surgery.
Each of these six possible risk factors will be registered dichotomously
(yes/no). Association between the presence of a possible risk factor the
occurrence of clinically relevant SRML will be investigated.
Study burden and risks
Since the measurements consist of a combination of standard measuring methods
that do not carry risks with them, it is extremely unlikely that adverse events
will occur during the study period. The burden for patients consists of seven
different measuring points, including one preoperatively, four during hospital
stay after surgery, and two in the outpatient clinical three and six months
after surgery. All visits are standard care in the Netherlands so patients have
no additional scheduled visits. QoL (WHOQOL-Bref and RAND-36) and fatigue
(MFI-20) questionnaires will be assessed at baseline, and three and six months
after surgery. The expected burden is 60 minutes per time point. No new
investigational treatment with possible risks is being used.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
* Female or male aged at least 18 years;
* The patient must speak the Dutch language;
* The patient understands the purpose of the study and has given written informed consent to participate in the study;
* Diagnosed or the suspicion of a liver tumour (primary cancer or colorectal liver metastases), pancreatic malignancy, bile duct malignancy, colon tumour, rectum tumour, or pseudomyxoma peritonei;
* Scheduled for open major abdominal surgery consisting of the following surgical procedures:
o Cytoreductive surgery combined with hyperthermic intraperitoneal intraoperative chemotherapy) (CRS with HIPEC)
o (Sub)total pelvic exenteration
o Pylorus preserving pancreaticoduodenectomy (PPPD)
o Whipple procedure (classic pancreaticoduodenectomy)
o Subtotal pancreatectomy
o Total pancreatectomy
o Major liver resection, defined as *3 liver segments
* The patient will be operated at the UMCG;
* Presence of a preoperative CT-scan of the abdomen.
Exclusion criteria
* Scheduled for laparoscopic surgery;
* Minor liver resections, defined as <3 liver segments;
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 | NL65843.042.18 |