Colorectal CancerREHABNCT01609361
Benefit of Rehabilitation Program in Colorectal Surgery
A study testing Rehabilitation program in people with Colorectal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Rehabilitation program improves operative results following conventional open colorectal surgery. Very few data are available on such program in laparoscopic colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Jul 2016
- Phase
- Interventional
- 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
Who may be able to join
- Age >= 18 years old
- Colorectal cancer
- Inform and consent form signed
- Patient has valid health insurance/coverage
- Functional capacity ≥ 4 METs (metabolic equivalents) (up 1 floor without stopping, walking down the street 5-7km / h, major domestic activities)
- Patients with laparoscopic resection for colorectal cancer including abdominoperineal resection
- Inclusion Criteria (arm : Laparoscopy + Rehabilitation program):
- Tobacco and alcohol weaning
Who cannot join
- MBI < 18kg/m2
- severe malnutrition
- Metastatic colorectal cancer
- Buzby Index <83
- Combined surgery (hepatic resection or segmental resection of small intestine)
- Urgent surgery
Show all 13Show fewer
- Pregnancy or maternal breastfeeding
- Body mass index (BMI)> 30 kg/m2
- Abdominoperineal resection
- Subtotal colectomy
- Total proctocolectomy
- Cons to Naropin Xylocaine, droperidol, ketamine
- Patient with a history of peptic ulcer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery
Rehabilitation program improves operative results following conventional open colorectal surgery. Very few data are available on such program in laparoscopic colorectal surgery.
Read the detailed description
The aim is to assess rehabilitation program in laparoscopic colorectal surgery in terms of 30 days peri operative complications
- Conditions
- Colorectal Cancer
- Being tested
- Rehabilitation program
- Keywords
- Rehabilitation program, Fast track surgery, Laparoscopic colorectal resection, Colorectal cancer, Morbidity
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation programOther
Rehabilitation program including specific anesthetic drugs, post operative fast track recovery (early diet, mobilisation, antalgics)
| Study group | Role | What they receive |
|---|---|---|
| 1: Standard surgery + Standard care | No intervention | standard surgery and Standard care after surgery |
| 2: Laparoscopy + Rehabilitation program | Other | Laparoscopic colorectal surgery with rehabilitation program Receives: Other: Rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative morbidity at 30 days according to DINDO CLAVIEN classification
Post operative morbidity at 30 days according to DINDO CLAVIEN classification (grade I to IV)
Measured: 30 days
Secondary outcomes (6)
Mortality according to DINDO CLAVIEN classification
Mortality according to DINDO CLAVIEN classification (grade V)
Measured: up to 30 days
Hospital stay and readmissions
Initial hospital stay and possible unscheduled readmissions
Measured: up to first month
Intravenous perfusion stay
Measured: participants will be followed until the end of hospitalization an expected average of 2 weeks
Global (SF36) quality of life
Global (SF36) and specific (GIQLI) quality of life Preoperative and at 1, 3, 6 months
Measured: Preoperative and at 1, 3, 6 months
Specific (GIQLI) quality of life
Global (SF36) and specific (GIQLI) quality of life Preoperative and at 1, 3, 6 months
Measured: Preoperative and at 1, 3, 6 months
Duration of laxation (gas and stool)
Measured: up to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609361
- Sponsor's protocol ID
- P111006
- Other IDs
- IDRCB
- Acronym
- REHAB
- Status last verified
- Aug 2016
- First submitted
- 20 Apr 2012
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01609361
- Acronym / sponsor ID
- REHAB / P111006
- Conditions
- Colorectal Cancer
- Keywords
- Rehabilitation program, Fast track surgery, Laparoscopic colorectal resection, Colorectal cancer, Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Jun 2012 (estimated)
- 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.
Rehabilitation program improves operative results following conventional open colorectal surgery. Very few data are available on such program in laparoscopic colorectal surgery.
Detailed description
The aim is to assess rehabilitation program in laparoscopic colorectal surgery in terms of 30 days peri operative complications
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Standard surgery + Standard care | No intervention | –standard surgery and Standard care after surgery |
| 2: Laparoscopy + Rehabilitation program | Other | Other: Rehabilitation programLaparoscopic colorectal surgery with rehabilitation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >= 18 years old
- Colorectal cancer
- Inform and consent form signed
- Patient has valid health insurance/coverage
- Functional capacity ≥ 4 METs (metabolic equivalents) (up 1 floor without stopping, walking down the street 5-7km / h, major domestic activities)
Key exclusion criteria (13 listed)
- MBI < 18kg/m2
- severe malnutrition
- Metastatic colorectal cancer
- Buzby Index <83
- Combined surgery (hepatic resection or segmental resection of small intestine)
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 |
|---|---|---|
| Rehabilitation programRehabilitation program including specific anesthetic drugs, post operative fast track recovery (early diet, mobilisation, antalgics) | Other | 2: Laparoscopy + Rehabilitation program |
Primary outcome
Post operative morbidity at 30 days according to DINDO CLAVIEN classification
Time frame: 30 days
Post operative morbidity at 30 days according to DINDO CLAVIEN classification (grade I to IV)
6 secondary outcomes
Mortality according to DINDO CLAVIEN classification
Time frame: up to 30 days
Hospital stay and readmissions
Time frame: up to first month
Intravenous perfusion stay
Time frame: participants will be followed until the end of hospitalization an expected average of 2 weeks
Global (SF36) quality of life
Time frame: Preoperative and at 1, 3, 6 months
Specific (GIQLI) quality of life
Time frame: Preoperative and at 1, 3, 6 months
Duration of laxation (gas and stool)
Time frame: up to hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation program in people with Colorectal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 inclusion and 13 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: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative morbidity at 30 days according to DINDO CLAVIEN classification (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2016.