No registrations found.
ID
Source
Brief title
Health condition
Patients diagnosed with abdominal cancer and treated with cytoreductive surgery (CRS) and a hyperthermic intraperitoneal chemotherapy (HIPEC) procedure
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sarcopenia defined as the degenerative loss of skeletal muscle mass that can be quantified by the CT measurement of the psoas muscle surface, normalized for patient height [cm2 m−2].
Secondary outcome
• Malabsorption
• Loss of muscle mass, measured by handgrip strength; arm circumference & triceps skinfold thickness; creatinin & urea in 24-hour urine.
• Incidence of Clavien Dindo complications
• Length of hospital stay and re-admittance rate
• Survival
• Quality of Life
Background summary
In this explorative observational study we will study the predictive factors for sarcopenia and malabsorption in patients with abdominal cancer undergoing cytoreductive surgery (CRS) combined with hyperthermal intraperitoneal chemotherapy
Study objective
Possible predictive factors for sarcopenia (primary outcome) could be: 1. The length and part of the resected small intestine, 2. Adjuvant (and type of) chemotherapy postoperatively, 3. Complications (like sepsis), 4. Nutritional intake (Energy and protein), 5. Preoperative muscle loss (sarcopenia), 6. Movement.
Possible predictive factors for malabsorption (secondary outcome) could be 1. The length and part of the resected small intestine 2. Adjuvant (and type of) chemotherapy postoperatively 3. Small intestinal bacterial overgrowth, especially when the ileocecal valve dysfunctions
Study design
Sarcopenia will be measured before surgery and 12 months after surgery.
The other endpoints will be registered at 3 and 6 months after surgery as well
Intervention
None, this is an explorative observational trial
Marjo Campmans-Kuijpers
Postbus 30.001
Groningen 9700RB
The Netherlands
06-55256587
M.J.E.Campmans-Kuijpers@UMCG.nl
Marjo Campmans-Kuijpers
Postbus 30.001
Groningen 9700RB
The Netherlands
06-55256587
M.J.E.Campmans-Kuijpers@UMCG.nl
Inclusion criteria
• Patients that undergo CRS and HIPEC procedure at the University Medical Center Groningen (UMCG)
• Written informed consent
• Age > 18 years
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Not fit for surgery
• Inability to provide written consent or inability to fill out questionnaires
• Karnofsky Performance Status < 80
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5961 |
| NTR-old | NTR6327 |
| CCMO | NL57812.042.16 |
| OMON | NL-OMON42927 |