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THE MUSCLE POWER STUDY: Surgery related muscle loss and muscle strength after complex abdominal surgery for pseudomyxoma peritonei, pancreatic, liver and colorectal cancer

THE MUSCLE POWER STUDY: Surgery related muscle loss and muscle strength after complex abdominal surgery for pseudomyxoma peritonei, pancreatic, liver and colorectal cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28560
Enrollment
178
Registered
2019-02-07
Start date
2019-02-07
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

• pseudomyxoma peritonei (PMP) • liver tumor (primary cancer or colorectal liver metastases) • pancreatic cancer • bile duct cancer • colorectal cancer

Interventions

None

Sponsors

This work is supported by a grant from the UMCG Cancer Research Foundation (Institutional Foundation for Cancer Research and Development). The study protocol has not undergone any peer-review by this funding body, nor will they play a role in the analysis and interpretation of the data.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
For the different secondary endpoints patients will be divided in two subgroups: patients with and without clinically relevant SRML. Our secondary endpoints will be the difference within both groups regarding: • Amount of loss of muscle mass per day after surgery; • Total amount of loss of muscle mass during hospital stay; • Specific patterns of muscle loss after surgery; • Amount of decrease in muscle strength per day after surgery; • Total decrease in muscle strength during hospital stay; • Specific patterns of decrease in muscle strength after surgery; • Possible risk factors for clinically relevant SRML: o Insufficient physical activity postoperatively; o Insufficient protein intake postoperatively; o Sarcopenia preoperatively; o Age = 65 years; o Diabetes preoperatively; o Major postoperative complications; • Correlation of urinary Creatinine Excretion Rate (CER); • Correlation of Patient-Generated Subjective Global Assessment (PGSGA); • Unplanned readmissions within 30 days after discharge; • QoL and fatigue three and six months after surgery.

Contacts

Public ContactJudith Hentzen

University Medical Center Groningen (UMCG)

j.e.k.r.hentzen@umcg.nl+31614114137

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)