Enhanced postoperative mobilization and biotracking after colorectal oncological resection (INTENSE-Study)
Not Applicable
Recruiting
- Conditions
- Elective minimally invasive colorectal surgery for CRC
- Registration Number
- DRKS00033443
- Lead Sponsor
- Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Universitätsklinikum Hamburg-Eppendorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
All patients scheduled for elective minimally invasive (laparoscopic or robot-assisted) colorectal surgery for CRC
- no intended multivisceral resection (exceptions are small atypical liver wedge resections, biopsies, abdominal wall resection, partial prostate/bladder resection, adnexectomy, cholecystectomy)
- preoperatively mobile patients (e.g., not wheelchair bound)
- no contraindication for wearing activity tracker devices
Exclusion Criteria
- primary open surgical technique
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composed of two hierarchical endpoints:<br>1. postoperative duration to 5 predefined DCs<br>- GI-2 (a validated composite measure of GI recovery defined as the interval from surgery until first passage of stool and tolerance of solid intake for 24h in the absence of vomiting)<br>- ambulation independently or at the preoperative level<br>- no intravenous fluids or pain medication<br>- no fever and a serum C-reactive protein concentration <80 mg/l) <br><br>2. Number of steps during postoperative Days 1-5, as recorded using activity tracking wristbands.
- Secondary Outcome Measures
Name Time Method - length of hospital stay<br>- 30-day mortality, and 30-day overall morbidity according to the Clavien-Dindo classification <br>- number of steps on POD 1-5<br>- highest mobility level measured by the CHARMI®-Index (Liebl et al. PLOS ONE 2016)<br>- biodiversity data from the activity tracker (calorie consumption, sleep phases, oxygen saturation, heart rate on POD 1-5 and correlation with complications such as an increase in infection levels [white blood count, C-reactive protein]) will be analysed.<br>- Lebensqualitätserhebung (EQ-5D-3L)<br>