CClinicalTrials.gg
Sign In
CompletedNCT03758209PrehabVsERASUpdated Mar 17, 2020

Prehabilitation Versus Enhanced Recovery Program for Elective Colorectal Cancer Surgery.

An interventional study of Prehabilitation + ERAS and ERAS in Colorectal Cancer and Insulin Resistance, sponsored by St. Borbala Hospital. Completed at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-17.

Sponsored by St. Borbala Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
184
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Elective surgery is the most effective treatment option for colorectal cancer, however it has been recognized to be associated with high morbidity and mortality risks.

ERAS (Enhanced Recovery After Surgery) is a preoperative multimodality treatment package, which has been well investigated and proved to be effective in reducing early postoperative morbidity, mortality, length of hospital stay and hospital costs, as well. Still, a good proportion of patients are not suitable for ERAS program, mainly based on lack of compliance and the impaired physical function before surgery.

Prehabilitation Program is a recently introduced trimodal preoperative preparation (training) program, which addresses improvement of physical, mental and nutritional status of the high risk elective surgery patients.

This study aims to investigate the benefit of all efforts of a 4-6-week preoperative preparation program (Prehabilitation) being added to an established ERAS protocol.

Read the detailed description

Aim:

Colorectal cancer patients with a planned resection are tested if a complex, trimodal rehabilitation program can hold functional and morbidity benefit for them.

In the prospective, randomized (1:1) study control patient group will be the well established and tested ERAS (enhanced recovery after surgery) Program.

Study protocol in details:

  1. First visit: Outpatient Department of Surgery

    On both arms:

    • History taking (including family history and oncologic history);
    • Physical examination
    • Operation indication, type of procedure and date of procedure agreed;
    • Organizing further investigations, anesthesia;
    • Operative risk assessment ("ACS - surgical risk calculator");
    • Study patient identifier Nr generated;

  2. Nurse-led ERAS/Prehab clinic: randomization

    On both arms:

    • Randomization (Prehabilitation Program / ERAS Program).
    • Nurse led clinic assessment ("study nurse"): .i. CaseReportForm (CRF) filled in.

    .ii. Patient data (personal data, demographics, history) .iii. Anthropometrics (BMI, MUST, Body fat % measurement). .iv. Mental hygienic status assessment (smoking, alcohol consumption, anxiety, depression, sleeping disorders).

    .v. Cardiovascular status (resting HR, RR). .vi. Operative risk assessment (CR-Possum score). .vii. Preoperative counseling (operation type, preparation, pain management, discharge plan).

    .viii. Preoperative nutritional planning (education, nutrient prescription). .ix. Alcohol intake and smoking cessation - information given. .x. Stoma education started. .xi. Consent signed, patient workbook handed over. .xii. Respiratory test referral.

  3. Physiotherapy, first visit

    Both on control and interventional arms:

    • Respiratory function test recorded.
    • Physical status tested (6MWD) on a treadmill.

    Just on Prehabilitation arm:

    • Respiratory training education.
    • Respiratory trainer device usage educated.
    • Daily activity (walking) planned.

  4. Physiotherapy - second/third/fourth visit (weekly)

    Just on Prehabilitation arm:

    • Previous week activity reviewed as to workbook.
    • Physical assessment: 6MWD, FVC.
    • Next week activity planned.

  5. Psychic preparation

    Just on Prehabilitation arm:

    • Once a week half an hour group relaxation training - regardless of the stage of prehabilitation program.

  6. Admission to the Surgical Ward a day before surgery

    Both on control and interventional arm:

    • Preoperative assessment: .i. Anthropometrics (BMI, body fat%). .ii. Cardiovascular stage (resting HR and RR), ECG. .iii. Respiratory function tests.

    .iv. Physical status (6MWD) .v. Mental status (Hospital Anxiety and Depression Scale (HADS)) assessment.

    • Preoperative preparation (as to ERAS protocol).
    • Postoperative care (ITU, pain management, mobilization, oral nutrition built up, drains early removal, complications recorded (Clavien-Dindo-classification)).
    • Stoma education.
    • Dietary education.
    • On discharge: Quality of Life (QoL) SF36 - (36-Item Short Form Survey from the RAND Medical Outcomes Study).
  7. Postoperative follow up:

Both on control and interventional arms:

  • Assessment (4th and 8th week post op.):

.i. Anthropometrics (BMI, Body fat %) .ii. Cardiovascular status (resting HR and RR). .iii. Respiratory function tests. .iv. Physical status (6MWD).

02

Conditions studied

  • Colorectal Cancer
  • Insulin Resistance

Keywords

  • Morbidity, Mortality, Complication, Prehabilitation, ERAS
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 184 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

St. Borbala Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patient with histologically proven primary colorectal adenocarcinoma
  • any stage of colorectal cancer
  • elective operation
  • curative intention
  • informed consent signed by patient

Exclusion criteria

Exclusion Criteria:

  • emergency operation
  • palliative operation
  • non-colorectal, second malignancy
  • pregnancy
  • patient not giving consent
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
184 participants (actual)

Study arms

  • Experimental
    Prehabilitation + ERAS

    Patients receiving a formal preoperative preparation on: * Physical status (walking, respiratory training) * Nutrition (nutritional supplements) * Mental status (weekly groups led by clinical psychologist on anxiety and depression management). Each patient will be treated in an ERAS program preoperatively.

    Procedure: Prehabilitation + ERAS · Procedure: ERAS

  • Active comparator
    ERAS

    Each patient will be treated in an ERAS program preoperatively. No specific preoperative training will be involved apart from nutritional status assessment and nutritional supplements.

    Procedure: ERAS

Interventions

  • ProcedurePrehabilitation + ERAS

    Prehabilitation will cover a range preoperative education and exercises (weekly) on diet, physical activity (daily walking), respiratory training (forced deep inspiration with spirometer device), as well as anxiolytic group psychotherapy.

  • ProcedureERAS

    Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.

    Also known as: Enhanced Recovery After Surgery Program

06

What researchers measure

Primary outcomes

  1. Length of hospital stay

    Postoperative length of hospital stay in days.

    Time frame: within 45 days

  2. Number of days spent on ICU (Intensive care unit).

    Number of days observed on ICU right after operation.

    Time frame: within 45 days postoperative

  3. Morbidity (early) classified after Clavien-Dindo.

    7-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.

    Time frame: 7 days (until 8th postoperative day) postoperative

  4. Morbidity (long term) classified after Clavien-Dindo.

    30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.

    Time frame: 30 days (until 31st postoperative day)

  5. 30-day mortality

    30-day mortality of each patient will be recorded.

    Time frame: 30 days postoperative

  6. 90-day mortality

    90-day mortality of each patient will be recorded.

    Time frame: 90 days postoperative

  7. Change in preoperative functional status - 6MWD by operation

    6MWD (6-minute walking distance test)

    Time frame: Measured points: 4 weeks before surgery, on day of hospital admission

  8. Change in postoperative functional status - 6MWD by the end of rehabilitation

    6MWD (6-minute walking distance test)

    Time frame: Measured points: 4 weeks before surgery, 8 weeks after operation

  9. Change in preoperative functional status - FVC by operation

    FVC (forced vital capacity) will be measured.

    Time frame: Measured points: 4 weeks before surgery, on day of hospital admission

  10. Change in preoperative functional status - FVC by the end of rehabilitation

    FVC (forced vital capacity) will be measured.

    Time frame: Measured points: 4 weeks before surgery, 8 weeks after operation

Secondary outcomes

  1. Delay in beginning of adjuvant oncotherapy (chemotherapy, radiotherapy).

    Sufficient recovery time until fitness of adjuvant chemo/radiotherapy will be recorded.

    Time frame: within 8 weeks, if adjuvant oncotherapy is needed

07

Study locations

1 site
  • Department of Surgery, St. Borbala Hospital
    Tatabánya, 2800, Hungary
08

References and documents

Publications

  • Souwer ETD, Bastiaannet E, de Bruijn S, Breugom AJ, van den Bos F, Portielje JEA, Dekker JWT. Comprehensive multidisciplinary care program for elderly colorectal cancer patients: "From prehabilitation to independence". Eur J Surg Oncol. 2018 Dec;44(12):1894-1900. doi: 10.1016/j.ejso.2018.08.028. Epub 2018 Sep 8. PubMed 30266205 ↗
  • Bousquet-Dion G, Awasthi R, Loiselle SE, Minnella EM, Agnihotram RV, Bergdahl A, Carli F, Scheede-Bergdahl C. Evaluation of supervised multimodal prehabilitation programme in cancer patients undergoing colorectal resection: a randomized control trial. Acta Oncol. 2018 Jun;57(6):849-859. doi: 10.1080/0284186X.2017.1423180. Epub 2018 Jan 12. PubMed 29327644 ↗
  • Chen BP, Awasthi R, Sweet SN, Minnella EM, Bergdahl A, Santa Mina D, Carli F, Scheede-Bergdahl C. Four-week prehabilitation program is sufficient to modify exercise behaviors and improve preoperative functional walking capacity in patients with colorectal cancer. Support Care Cancer. 2017 Jan;25(1):33-40. doi: 10.1007/s00520-016-3379-8. Epub 2016 Aug 18. PubMed 27539131 ↗
  • Carli F, Silver JK, Feldman LS, McKee A, Gilman S, Gillis C, Scheede-Bergdahl C, Gamsa A, Stout N, Hirsch B. Surgical Prehabilitation in Patients with Cancer: State-of-the-Science and Recommendations for Future Research from a Panel of Subject Matter Experts. Phys Med Rehabil Clin N Am. 2017 Feb;28(1):49-64. doi: 10.1016/j.pmr.2016.09.002. PubMed 27913000 ↗
  • Banky B, Lakatos M, Varga K, Hansagi E, Horvath E, Jaray G. [Enhanced Recovery Program in colorectal surgery]. Magy Seb. 2018 Mar;71(1):3-11. doi: 10.1556/1046.71.2018.1.1. Hungarian. PubMed 29536753 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03758209
Lead sponsor
St. Borbala Hospital
Collaborators
St. Borbala Hospital, Department of Surgery, Semmelweis University
Responsible party
Dr. Balázs Bánky PhD (Head of the Department of Surgery, St. Borbala Hospital, St. Borbala Hospital) — Principal investigator
First posted
Nov 29, 2018
Start date
Nov 1, 2018
Primary completion
Nov 1, 2019
Completion
Nov 1, 2019
Last update
Mar 17, 2020

Study contacts

Balázs Bánky, PhD
study director · Department of Surgery, St. Borbala Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Colorectal Neoplasms→

Other studies from this sponsor

St. Borbala Hospital

Start the discussion