We hypothesize that 50% of our patient population will have clinically relevant SRML within one week after major abdominal surgery. Risk factors for developing clinically relevant SRML will be sarcopenia preoperatively, diabetes preoperatively, age…
ID
Bron
Verkorte titel
Aandoening
• pseudomyxoma peritonei (PMP)
• liver tumor (primary cancer or colorectal liver metastases)
• pancreatic cancer
• bile duct cancer
• colorectal cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome of this study is the proportion of patients who have clinically relevant SRML, defined as ≥5% muscle loss within one week after surgery measured by bedside ultrasound measurements.
Achtergrond van het onderzoek
The MUSCLE POWER study is an prospective, observational cohort study that investigates the presence, impact and risk factors for clinically relevant SRML in one hundred and seventy-eight cancer patients after major abdominal surgery by using bedside ultrasound measurements, squeeze and force measurements and QoL and fatigue questionnaires. Primary endpoint is the proportion of patients with clinically relevant SRML defined as ≥5% muscle loss within one week after surgery measured by the cross sectional area (CSA) of four different muscles: m. biceps brachii, m. rectus abdominis, m. rectus femoris, and m. vastus intermedius. Secondary endpoints include the amount of loss of muscle mass and strength during hospital stay, specific patterns of loss of muscle mass and strength, unplanned readmissions, and correlation with QoL and fatigue three and six months after surgery. Possible risk factors for clinically relevant SRML – consisting of age ≥ 65 years, diabetes preoperatively, sarcopenia preoperatively, major postoperative complications (Clavien-Dindo ≥III), insufficient physical activity and protein intake postoperatively – will be explored. Patients will wear a motility tracker to measure daily physical activity and a dietician will monitor daily protein intake. Differences between patients with and without clinically relevant SRML will be compared using a student t-test, Mann Whitney U-test, or Pearson chi-square test as appropriate. Different possible risk factors for clinically relevant SRML will be investigated with a multivariable logistic regression analyses with a backward stepwise approach. Variables with a p < 0.05 will be retrained in the final multivariable model.
Doel van het onderzoek
We hypothesize that 50% of our patient population will have clinically relevant SRML within one week after major abdominal surgery. Risk factors for developing clinically relevant SRML will be sarcopenia preoperatively, diabetes preoperatively, age ≥65 years, occurrence of major postoperative complications, insufficient physical activity and insufficient protein intake during the first week after surgery. Clinically relevant SRML will also be associated with fatigue and a reduced QoL three and six months after surgery.
Onderzoeksopzet
-
Onderzoeksproduct en/of interventie
None
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a patient must meet all of the following inclusion criteria:
• Age ≥ 18 years;
• Able to read and understand the Dutch language;
• Diagnosed or the suspicion of a liver tumor (primary cancer or colorectal liver metastases), pancreatic malignancy, bile duct malignancy, colon tumor, rectum tumor, or pseudomyxoma peritonei;
• Scheduled to undergo elective open major abdominal surgery at UMCG, 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 (sub)total pancreatectomy; or
o major liver resection defined as ≥3 liver segments.
• Presence of a preoperative computed tomography (CT) of the abdomen to determine sarcopenia preoperatively;
• Has given informed consent to participate in the study.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential eligible patient who meets any of the following exclusion criteria will be excluded from participation in this study:
• Scheduled to undergo emergency resection;
• Scheduled to undergo laparoscopic surgery;
• Scheduled to undergo minor liver resections (defined as <3 liver segments);
• Inability to co-operate and give informed consent.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7505 |
| Ander register | METC UMCG : METc 2018/361 |