Enhanced postoperative mobilization and biotracking after colorectal oncological resection (INTENSE-Study)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033443

Enrollment

100

Registered

2024-01-25

Start date

2024-04-01

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Elective minimally invasive colorectal surgery for CRC

Interventions

Group 1: Intervention group: In the intervention group, the patients are instructed to complete the EPM within the established ERAS setting from the day of the operation (POD 0) until the 5th postoper

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: - primary open surgical technique

Design outcomes

Primary

Measure	Time frame
Composed of two hierarchical endpoints: 1. postoperative duration to 5 predefined DCs - 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) - ambulation independently or at the preoperative level - no intravenous fluids or pain medication - no fever and a serum C-reactive protein concentration <80 mg/l) 2. Number of steps during postoperative Days 1-5, as recorded using activity tracking wristbands.	—

Measure

Time frame

Composed of two hierarchical endpoints: 1. postoperative duration to 5 predefined DCs - 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) - ambulation independently or at the preoperative level - no intravenous fluids or pain medication - no fever and a serum C-reactive protein concentration <80 mg/l) 2. Number of steps during postoperative Days 1-5, as recorded using activity tracking wristbands.

—

Secondary

Measure	Time frame
- length of hospital stay - 30-day mortality, and 30-day overall morbidity according to the Clavien-Dindo classification - number of steps on POD 1-5 - highest mobility level measured by the CHARMI®-Index (Liebl et al. PLOS ONE 2016) - 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. - Lebensqualitätserhebung (EQ-5D-3L)	—

Measure

Time frame

- length of hospital stay - 30-day mortality, and 30-day overall morbidity according to the Clavien-Dindo classification - number of steps on POD 1-5 - highest mobility level measured by the CHARMI®-Index (Liebl et al. PLOS ONE 2016) - 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. - Lebensqualitätserhebung (EQ-5D-3L)

—

Countries

Germany

Contacts

Public ContactThilo Welsch

Klinik für Allgemein-, Viszeral- und Thoraxchirurgie

t.welsch@uke.de+4915228842079

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026