Skip to content

Prehabilitation for bowel cancer patients undergoing surgery to improve fitness and reduce complications

Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and lower postoperative complications

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21887
Enrollment
715
Registered
2016-08-01
Start date
2017-06-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Colorectal carcinoma

Interventions

1. Patient triage medical conditions 2. Exercise program 3. Nutritional supplements 4. Smoke cessation 5. Psychological coping

Sponsors

Máxima MC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients undergoing elective colorectal surgery for cancer.

Exclusion criteria

Exclusion criteria: • metastatic disease known preoperatively, • paralytic or immobilized patients (not capable to perform exercise or 6MWT), • premorbid conditions or orthopedic impairments that contraindicate exercise (to be assessed by sport physician involved in and during cardiopulmonary exercise testing), • cognitive disabilities, • chronic renal failure (dialysis or creatinine > 250 µmol)m • ASA score 4 or higher, • illiteracy (disability to read and understand Dutch), • planned abdominoperineal resection (inability to perform postoperative tests), • second primary tumour other than colorectal carcinoma simultaneously diagnosed, • not able to delay surgery for four weeks due to for example clinical signs of obstruction or short-course neoadjuvant radiotherapy, directly followed by surgery.

Design outcomes

Primary

MeasureTime frame
The first primary outcome is postoperative complications, as scored using the Comprehensive Complication Index score as a combined outcome measure of morbidity and mortality. The second primary/confirmatory outcome is the patients’ functional capacity, as measured by the six-minute walk test (6MWT).

Secondary

MeasureTime frame
Secondary outcomes will include indirect 1 repetition measures (1-RM) and cardiopulmonary exercise testing (CPET), Health-related quality of life (HRQL), Sit-to-Stand test, Fried Frailty Score, hand grip strength, body composition, stair climb test, Physical activity level measured through an activity questionnaire, depression and anxiety assessed by GAD-7 and PHQ-9, nutritional status, compliance, length of hospital stay, and costs.

Contacts

Public ContactGerrit Slooter

P.O. Box 7777

g.slooter@mmc.nl+3140 – 8885320

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)