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Does Prehabilitation Improve Outcome in Coloncancer Surgery?

ConditionSurgery--Complications
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorRegion Skane

About this trial

The study aims to find out if complications after surgery for large bowel (colon) cancer can be reduced or avoided in the most frail and elderly by letting them go through an exercise- and diet regime prior to the surgical procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

60 years of older

Colon cancer diagnosis (macroscopic, microscopic or x-ray diagnosed)

Ventilatory Anaerobic Threshold <11mg/ml/kg

Planned open or laparoscopic colectomy due to colon cancer

Disqualifiers

Lower extremity amputee

Disease requiring radio- and/or chemotherapy prior to surgery/palliative disease

Distal metastases (Locoregional lymph nodes are OK)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prehabilitation and Immunonutrition

    Other intervention

    See study synopsis

  • Standard Care Arm

    Other intervention

    Standard care as per the daily routines of the Hospital at which the study takes place

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Standard Care ArmActive comparator 1 intervention
Group B: Interventional ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complications

Severity of postoperative complications according do Clavien-Dindo

Time frame
Assessed when patient is discharged from hospital
2

Complications

Number of complication(s) according to POMS

Time frame
Assessed at postoperative day 5.

Secondary outcomes

1

Quality of life with SF-36

Quality of life

Time frame
At point in time when patient is informed of the cancer, after prehabilitation (just before surgery), 30 days, 2, 3 and 6 months, 1, 3 and 5 years after surgery.
2

Disease-free survival

Cancer-free survival Cancer-free survival of the group of the group

Time frame
30 and 90 days after surgery, 1, 3 and 5 years after surgery.
3

Overall survival

Overall survival of the group (taking all causes of death into account)

Time frame
30 and 90 days after surgery, 1, 3 and 5 years after surgery.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Skane

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: