Colo-rectal Cancerprehab-csptNCT03543514
PREHABILITATION RECTAL CANCER DURING ADJUVANCY VS BEFORE SURGERY
An observational study of Colo-rectal Cancer, run by Corporacion Parc Tauli at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- TRIMODAL PREHABILITATION
- How many people
- 70 participants
- Where
- 2 sitesSpain
- Study dates
- 2 Feb 2022to 30 Mar 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by a colon or rectal tumor that have to undergo surgery.
Who may be able to join
- Patient diagnosed with colorectal neoplasia
- Need colorectal surgery with curative indication
- Scheduled surgery
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Laura Mora López
Sabadell, Barcelona, 08208
Laura Mora, Dr., 34639101033, mora.lopez.laura@gmail.com
- Recruiting
Laura Mora Löpez
Sabadell, Barcelona, 08208
Laura Mora, Dr.
About this study
Official title: STUDY ON THE EFFECT OF TRIMODAL PREHABILITATION IN PATIENTS SUBMITTED TO RECTAL SURGERY DURING ADJUVANCY OR BEFORE SURGERY
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).
Read the detailed 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.
- Conditions
- Colo-rectal Cancer
- Being tested
- TRIMODAL PREHABILITATION
- Keywords
- colon cancer, rectal cancer, prehabilitation
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIMODAL PREHABILITATIONOther
Also called PHYSICAL INTERVENTION, NUTRITIONAL INTERVENTION, EMOTIONAL INTERVENTION
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.
| Study group | Role | What they receive |
|---|---|---|
| PREHABILITATION GROUP | Patients affected on Cold-rectal cancer who needs surgery. We made trimodal prehabilitation Receives: Other: TRIMODAL PREHABILITATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (3)
Six minutes walking test (6-MWT)
Physical capacity
Measured: 30 days
Malnutrion Universal Screening Tool (MUST)
Nutritional condition
Measured: 30 days
Hospital Anxiety and Depression Scale (HADS)
Emotional capacity
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start2 Feb 2022
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Mora-Lopez, Corporacion Parc Tauli
- Investigators
- Laura Mora, Dr., Principal investigator, Hospital Universitari Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543514
- Sponsor's protocol ID
- PREHAB-CSPT
- Acronym
- prehab-cspt
- Status last verified
- Mar 2022
- First submitted
- 26 Apr 2018
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There's no plan to share IPD to other researchers
Publications
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.
PubMed 14627258Spanjersberg 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;2011(2):CD007635. doi: 10.1002/14651858.CD007635.pub2.
PubMed 21328298Christensen T, Kehlet H. Postoperative fatigue. World J Surg. 1993 Mar-Apr;17(2):220-5. doi: 10.1007/BF01658930.
PubMed 8511917Carli 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.
PubMed 12218518Carli 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.
PubMed 15585997Wilson 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.
PubMed 20573634Lawrence 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.
PubMed 15501119Carli 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.
PubMed 20602503Mayo 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.
PubMed 21878237Burden 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.
PubMed 20487172Li 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.
PubMed 23052535Leon-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.
PubMed 17311247Dindo 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.
PubMed 15273542Slankamenac 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.
PubMed 23728278Slankamenac 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.
PubMed 25379846
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY ON THE EFFECT OF TRIMODAL PREHABILITATION IN PATIENTS SUBMITTED TO RECTAL SURGERY DURING ADJUVANCY OR BEFORE SURGERY
- ClinicalTrials.gov ID
- NCT03543514
- Acronym / sponsor ID
- prehab-cspt / PREHAB-CSPT
- Conditions
- Colo-rectal Cancer
- Keywords
- colon cancer, rectal cancer, prehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PREHABILITATION GROUP | – | Other: TRIMODAL PREHABILITATIONPatients affected on Cold-rectal cancer who needs surgery. We made trimodal prehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by a colon or rectal tumor that have to undergo surgery.
Key inclusion criteria (3 listed)
- Patient diagnosed with colorectal neoplasia
- Need colorectal surgery with curative indication
- Scheduled surgery
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRIMODAL PREHABILITATIONAlso: PHYSICAL INTERVENTION, NUTRITIONAL INTERVENTION, EMOTIONAL INTERVENTIONTrimodal 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 | PREHABILITATION GROUP |
Primary outcome
Crompehension Complexity Index (CCI)
Time frame: 30 days
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.
3 secondary outcomes
Six minutes walking test (6-MWT)
Time frame: 30 days
Malnutrion Universal Screening Tool (MUST)
Time frame: 30 days
Hospital Anxiety and Depression Scale (HADS)
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Background: PubMed 14627258Zingmond 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.
- Background: PubMed 21328298Spanjersberg 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;2011(2):CD007635. doi: 10.1002/14651858.CD007635.pub2.
- Background: PubMed 8511917Christensen T, Kehlet H. Postoperative fatigue. World J Surg. 1993 Mar-Apr;17(2):220-5. doi: 10.1007/BF01658930.
- Background: PubMed 12218518Carli 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.
- Background: PubMed 15585997Carli 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.
- Background: PubMed 20573634Wilson 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.
- Background: PubMed 15501119Lawrence 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.
- Background: PubMed 20602503Carli 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.
- Background: PubMed 21878237Mayo 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.
- Background: PubMed 20487172Burden 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.
- Background: PubMed 23052535Li 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.
- Background: PubMed 17311247Leon-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.
- Individual participant dataSharing planned: No. There's no plan to share IPD to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Mora, Dr. principal investigator
Hospital Universitari Parc Tauli
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer, run by Corporacion Parc Tauli at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Mora, Dr (34639101033, mora.lopez.laura@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crompehension Complexity Index (CCI) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03543514, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.