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NCT04595604Completed

Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.

Source: ClinicalTrials.gov · Last updated 29 Nov 2024

Brief summary (registry, in English)

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. Trimodal Prehabilitation Program is a recently introduced 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. Additionally the effect of trimodal prehabilitation on gut microbiom diversity and its relation to clinical outcome will be analyzed.

Status (registry)
Completed
Study type
Interventional
Enrollment
500 (actual)
First submitted
30 Sept 2020
Start date
7 Sept 2020
Primary completion date
7 Aug 2022
Lead sponsor
St. Borbala Hospital
NCT number
NCT04595604

What you commit to

  • Study type: Interventional
  • Participants enrolled: 500
  • From 7 Sept 2020 to the primary completion date, 7 Aug 2022
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • non-colorectal, second malignancy

Other

  • emergency operation
  • palliative operation
  • pregnancy
  • patient not giving consent

Who the study is looking for

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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. Borbala Hospital
Coordinator of this site? Confirm its status
TatabányaHungaryUnknown status
Department of Surgery, St. Borbala Hospital
Coordinator of this site? Confirm its status
TatabányaHungaryUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.