PREHABILITATION RECTAL CANCER DURING ADJUVANCY VS BEFORE SURGERY
NCT ID: NCT03543514
Last Updated: 2022-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
70 participants
OBSERVATIONAL
2022-02-02
2025-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prehabilitation in Rectal Cancer: During Neoadjuvant Therapy vs Preoperative
NCT05286086
Prehabilitation in Colorectal Cancer
NCT03096951
Multimodal Prehabilitation for Colorectal Surgery
NCT01356264
Prehabilitation in Geriatric Patients With Colorectal Neoplasia
NCT05851235
Effect of Multimodal Prehabilitation After Colorectal Cancer Surgery
NCT05854394
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PREHABILITATION GROUP
Patients affected on Cold-rectal cancer who needs surgery. We made trimodal prehabilitation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Need colorectal surgery with curative indication
* Scheduled surgery
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Corporacion Parc Tauli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Laura Mora-Lopez
DOCTOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laura Mora, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Parc Tauli
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Laura Mora López
Sabadell, Barcelona, Spain
Laura Mora Löpez
Sabadell, Barcelona, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Laura Mora, Dr.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Christensen T, Kehlet H. Postoperative fatigue. World J Surg. 1993 Mar-Apr;17(2):220-5. doi: 10.1007/BF01658930.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PREHAB-CSPT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.