PREHABILITATION RECTAL CANCER DURING ADJUVANCY VS BEFORE SURGERY

Colo-rectal Cancer Clinical Trial

— prehab-cspt  

Official title:

STUDY ON THE EFFECT OF TRIMODAL PREHABILITATION IN PATIENTS SUBMITTED TO RECTAL SURGERY DURING ADJUVANCY OR BEFORE SURGERY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03543514
• Other study ID #: PREHAB-CSPT
• Status: Recruiting
• Start date: February 2, 2022
• Est. completion date: March 30, 2025

Study information

• Verified date: March 2022
• Source: Corporacion Parc Tauli
• Contact: Laura Mora, Dr
• Phone: 34639101033
• Email: mora.lopez.laura[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Description:

Protocol for colorectal neoplasia patients who need surgery by modifying the current one. Until now, in the preoperative time, the anesthetist evaluated the need for some specific action such as pre-operative iron administration to avoid perioperative transfusions or the need to assess some of the patient's morbidities to try to optimize it. In the perioperative period in our hospital, the criteria of the Multimodal and Fast-Tcack Rehabilitation programs have been applied for a long time and there are some trajectories that allow standardization of patient management once they have been admitted.

It is demonstrated in other centers and in other surgical pathologies that, in addition to what we are already applying to our center, modify the preoperative preparation of our patients and try to improve their "functional capacity" results of lower morbidity and mortality and the subsequent recovery of patients can greatly improve . This is called prehabilitation. Pretreatment consists in a change in preoperative preparation at three levels. The concept of preoperative preparation changes and the patient is actively involved in it. Three levels of the patient are controlled: functional or physical level, nutritional level and emotional level, by means of pots and they are encouraged to make a series of changes in their habitual life (exercise, dietary advice, mindfullness techniques) that increase its functional capacity. This is related to a decrease in morbidity and mortality and in addition to a better and faster postoperative recovery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 30, 2025
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient diagnosed with colorectal neoplasia

• Need colorectal surgery with curative indication

• Scheduled surgery

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• TRIMODAL PREHABILITATION
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.

Locations

Country	Name	City	State
Spain	Laura Mora López	Sabadell	Barcelona
Spain	Laura Mora Löpez	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

References & Publications (16)

Barberan-Garcia A, Ubré M, Roca J, Lacy AM, Burgos F, Risco R, Momblán D, Balust J, Blanco I, Martínez-Pallí 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Christensen T, Kehlet H. Postoperative fatigue. World J Surg. 1993 Mar-Apr;17(2):220-5. Review. — View Citation

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. — View Citation

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. — View Citation

León-Pizarro C, Gich I, Barthe E, Rovirosa A, Farrús 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Six minutes walking test (6-MWT)	Physical capacity	30 days
Secondary	Malnutrion Universal Screening Tool (MUST)	Nutritional condition	30 days
Secondary	Hospital Anxiety and Depression Scale (HADS)	Emotional capacity	30 days