PREHABILITATION RECTAL CANCER DURING ADJUVANCY VS BEFORE SURGERY

NCT03543514 | Unknown DMC

• 1 other identifier: PREHAB-CSPT
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

Preoperative preparation protocol (prehabilitation) for patients diagnosed with colorectal cancer who need surgery. It consists of a change in the preoperative preparation. The patient is an active part of their preparation and the professionals help to achieve a better functional capacity to diminish morbidity and accelerate recovery. Three levels are controlled:

• Physical: control and stimulation to exercise at home.
• Nutrition: control and advice through homemade recipes.
• Emotional: control of the level of haste or depression and advice of mindfullness techniques at home. If they need specific help they are derived from specialized professionals (rehabilitator, nutritionist / endocrinologist, psychologist).

Conditions

Colo-rectal Cancer

Keywords

colon cancer, rectal cancer, prehabilitation

Outcome Measures

Primary Outcomes (1)

• Crompehension Complexity Index (CCI)

  General morbidity due to the improvement of the physical capacity, the nutritional profile and the diminution of the psychic stroke can be diminished throughout the process and the return to the basal situation.

  30 days

Secondary Outcomes (3)

• Six minutes walking test (6-MWT)

  30 days

• Malnutrion Universal Screening Tool (MUST)

  30 days

• Hospital Anxiety and Depression Scale (HADS)

  30 days

Study Arms (1)

PREHABILITATION GROUP

Patients affected on Cold-rectal cancer who needs surgery. We made trimodal prehabilitation

Other: TRIMODAL PREHABILITATION

Interventions

TRIMODAL PREHABILITATION OTHER

Trimodal prehabilitation application in the form of: * Control with the 6-minute walking test and podometer of physical activity * Dietary advice to be able to perform a hyperproteic diet * Mindfullnes to improve the emotional level.

Also known as: PHYSICAL INTERVENTION, NUTRITIONAL INTERVENTION, EMOTIONAL INTERVENTION

PREHABILITATION GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by a colon or rectal tumor that have to undergo surgery.

You may qualify if:

• Patient diagnosed with colorectal neoplasia
• Need colorectal surgery with curative indication
• Scheduled surgery

You may not qualify if:

• Patients who refuse to enter the study
• Patients with indication of palliative surgery
• Surgeries that involve colon and other organs
• Urgent surgery
• Basic pathology that does not allow to carry out some of the explorations necessary to carry out the trimodal pre-treatment.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (2)

Laura Mora López

Sabadell, Barcelona, 08208, Spain

RECRUITING

Laura Mora Löpez

Sabadell, Barcelona, 08208, Spain

RECRUITING

Related Publications (16)

• Zingmond D, Maggard M, O'Connell J, Liu J, Etzioni D, Ko C. What predicts serious complications in colorectal cancer resection? Am Surg. 2003 Nov;69(11):969-74.

  PMID: 14627258 BACKGROUND

• Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD007635. doi: 10.1002/14651858.CD007635.pub2.

  PMID: 21328298 BACKGROUND

• Christensen T, Kehlet H. Postoperative fatigue. World J Surg. 1993 Mar-Apr;17(2):220-5. doi: 10.1007/BF01658930.

  PMID: 8511917 BACKGROUND

• Carli F, Mayo N, Klubien K, Schricker T, Trudel J, Belliveau P. Epidural analgesia enhances functional exercise capacity and health-related quality of life after colonic surgery: results of a randomized trial. Anesthesiology. 2002 Sep;97(3):540-9. doi: 10.1097/00000542-200209000-00005.

  PMID: 12218518 BACKGROUND

• Carli F, Zavorsky GS. Optimizing functional exercise capacity in the elderly surgical population. Curr Opin Clin Nutr Metab Care. 2005 Jan;8(1):23-32. doi: 10.1097/00075197-200501000-00005.

  PMID: 15585997 BACKGROUND

• Wilson RJ, Davies S, Yates D, Redman J, Stone M. Impaired functional capacity is associated with all-cause mortality after major elective intra-abdominal surgery. Br J Anaesth. 2010 Sep;105(3):297-303. doi: 10.1093/bja/aeq128. Epub 2010 Jun 23.

  PMID: 20573634 BACKGROUND

• Lawrence VA, Hazuda HP, Cornell JE, Pederson T, Bradshaw PT, Mulrow CD, Page CP. Functional independence after major abdominal surgery in the elderly. J Am Coll Surg. 2004 Nov;199(5):762-72. doi: 10.1016/j.jamcollsurg.2004.05.280.

  PMID: 15501119 BACKGROUND

• Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg. 2010 Aug;97(8):1187-97. doi: 10.1002/bjs.7102.

  PMID: 20602503 BACKGROUND

• Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.

  PMID: 21878237 BACKGROUND

• Burden ST, Hill J, Shaffer JL, Todd C. Nutritional status of preoperative colorectal cancer patients. J Hum Nutr Diet. 2010 Aug;23(4):402-7. doi: 10.1111/j.1365-277X.2010.01070.x. Epub 2010 May 13.

  PMID: 20487172 BACKGROUND

• Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.

  PMID: 23052535 BACKGROUND

• Leon-Pizarro C, Gich I, Barthe E, Rovirosa A, Farrus B, Casas F, Verger E, Biete A, Craven-Bartle J, Sierra J, Arcusa A. A randomized trial of the effect of training in relaxation and guided imagery techniques in improving psychological and quality-of-life indices for gynecologic and breast brachytherapy patients. Psychooncology. 2007 Nov;16(11):971-9. doi: 10.1002/pon.1171.

  PMID: 17311247 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.

  PMID: 23728278 BACKGROUND

• Slankamenac K, Nederlof N, Pessaux P, de Jonge J, Wijnhoven BP, Breitenstein S, Oberkofler CE, Graf R, Puhan MA, Clavien PA. The comprehensive complication index: a novel and more sensitive endpoint for assessing outcome and reducing sample size in randomized controlled trials. Ann Surg. 2014 Nov;260(5):757-62; discussion 762-3. doi: 10.1097/SLA.0000000000000948.

  PMID: 25379846 BACKGROUND

• Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.

  PMID: 28489682 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Laura Mora, Dr.

  Hospital Universitari Parc Tauli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Mora, Dr

CONTACT

34639101033; mora.lopez.laura@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: June 1, 2018
• Study Start: February 2, 2022
• Primary Completion: August 30, 2024
• Study Completion: March 30, 2025
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)