Optimization of Patients' Physical and Mental Status Prior to Colorectal Cancer Surgery (OPT)

Optimization of Patients' Physical and Mental Status Prior to Colorectal Cancer Surgery -a Randomized Clinical Trial

Colorectal cancer is one of the most common cancers globally. A majority are operated on for the purpose of cure. Complications after surgery are common, involve long length of stay and increase the risk of later recurrence of cancer. Optimization of physical and mental function before surgery can reduce the risk of complications and provide a faster recovery. However, a standardized form for how optimization should be performed does not exist.

At Danderyd Hospital, Stockholm, Sweden, we are starting up an optimization center where patients are offered optimizing measures while waiting for surgery. This form of structured treatment has not been studied before and we therefore want to investigate outcomes in a randomized study.

All patients with colorectal cancer who are being examined for surgery are offered participation in the study. Randomization of 518 patients in to either an intervention group where the patients; are optimized for concomitant diseases, treated for malnutrition and overconsumption of alcohol and tobacco, undergoes an exercise program and receives psychosocial support before surgery, or a control group where patients are prepared for surgery according to current routines. Primary outcome is the difference in severe complications between the groups. Secondary outcome is difference in length of stay as well as fitness and mental well-being before and 30 days after the operation.If optimization before surgery reduces complications and shortens length of stay, the model can also be used by other operating specialties. This may result in a great improvement for the healthcare in general.

Study Overview

• Status: Recruiting
• Conditions: Complication,Postoperative; ERAS
• Intervention / Treatment: Behavioral: Optimisation

Detailed Description

A randomized controlled, unblinded study with block stratification for surgical procedures.

Intervention arm:

All patients in the intervention group will be treated in an "optimization center" which constitutes its own physical location at the hospital and functions as a day care unit staffed with doctors, contact nurses, physiotherapists, ERAS nurses and dietitians. An expert team of cardiologists, physiologists, renal physicians and endocrinologists are attached to the unit.

Day 1. (2-12 weeks before the operation). Multipel testing: Clinical status, ASA score, NSQIP score. Alcohol and Smoke score tests. Nutritional score. 6 minute walk test. Psychiatric score tests. If mortality risk >5% according to NSQIP, low performance on walk test, chair stand test. ASA 3-4, HbA1c >50 for non diabetics, >60 for diabetics or (GFR <45) = special attention from the expert team.

Day 2 until one week before surgery:

Home exercise 5 days / week. Organised (physiotherapist) exercise 2 days / week. Dietprogram with close follow-up. Psychosocial support. Smoking and alcohol cessation program

The week before surgery: The same tests as day 1. 30 days posted: The same tests as day 1.

Controlarm: The same tests as for the intervention group, day 1, the week before surgery and 30 days post. No interventions during the period.

The international ERAS database will be used to record data in the study. Consecutive registration of over 300 perioperative variables on each individual patient.

Examples of these variables are basic patient characteristics, preoperative variables such as information before surgery, laxation, nutrition, fluid intake, anemia and glucose optimization. Intraoperative variables such as body temperature, fluid supply, anesthesia method, bleeding, operation time and gastric tube. Postoperative variables such as catheter removal, nutrition, mobilization, nausea, paralytic ileus, specified complications, reoperations and length of stay after surgery. Compliance with the ERAS protocol will be registered.

• Study Type: Interventional
• Enrollment (Anticipated): 518
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klas Pekkari, MD, PhD,; Phone Number: 46707799817; Email: klas.pekkari@sll.se
• Study Contact Backup: Name: Helene Vibom, nurse; Phone Number: Danderyd; Email: helene.vibom@sll.se

Study Locations

• Sweden
  • Stockholm, Sweden, 18288
    • Recruiting
    • Ulf Oskar Gustafsson
    • Contact: Ulf Gustafsson; Phone Number: 46706073828; Email: ulf.o.gustafsson@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients, 18 years or older, with strong suspicion of colorectal cancer

Exclusion Criteria:

• Patients with dementia with severe cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Optimisation: Diet, organised exercise, psychosocial support	Behavioral: Optimisation; Defined optimisation
No Intervention: Control arm; Current standard preparation before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious complications	Can preoperative optimization change the proportion of serious complications after surgery (defined according to Clavien 3b-5) in intervention vs. control arm. ) in intervention vs. control arm	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperations	Change of proportion of reoperations in intervention vs. control arm	30 days
Length of stay (LOS)	Change of LOS (days) in intervention vs. control arm	30 days
Working capacity	Change of walking distance (meter) in intervention vs. control arm (6 minute walk test)	2-12 weeks
Weight loss	Change of weight loss (kg) in intervention vs. control arm	2-12 weeks
Psychosocial status	Change of points in Hospital and Anxiety scale (HAD) in intervention vs. control arm	2-12 weeks

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Study Chair: Josefin Karlsson, Nurse, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: RCT; ERAS; Optimisation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: RCT: OPTIMIZATION: 2021:9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Data Availability Statement

Due to Swedish legal restrictions and the current ethical approval for the study, data is not publicly available to share, but the research group can provide descriptive data in table form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No