Colorectal DisordersFT-SSNCT01646190
Fast-Track Colorectal Surgery in Senior Patients
A study testing Preoperative Carbohydrate load, individualized i.v fluids therapy and Fasting state after midnight in people with Colorectal Disorders, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Fast-track (FT) surgery is a multimodal, multidisciplinary-team approach to reduce perioperative surgical stress and injury after colorectal surgery, resulting in lower morbidity and enhanced recovery. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Colorectal Disorders
- What is being tested?
- Preoperative Carbohydrate load, individualized i.v fluids therapy and Fasting state after midnight
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2009to Dec 2013
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- senior patients (> or = 70 years at operation)
- elective colorectal surgery
Who cannot join
- emergency, liver-associated, revisional surgeries
- inability to discern or speak French/English, dementia
- absolute contraindication to systemic analgesia (severe allergic reaction)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital, Geneva
Geneva, 1211
Sandrine Ostermann, MD, PhD, +41 79 55 34161, sandrine.ostermann@hcuge.ch
Philippe Morel, Pr, Head, +41 22 37 27702, philippe.morel@hcuge.ch
About this study
Official title: Fast-Track Perioperative Care After Elective Colorectal Surgery in Senior Patients. Randomized Controlled Trial
Fast-track (FT) surgery is a multimodal, multidisciplinary-team approach to reduce perioperative surgical stress and injury after colorectal surgery, resulting in lower morbidity and enhanced recovery. As fast-track approach could probably be the most beneficial for senior patients to reduce postoperative morbidity and better preserve independency, only scarce information is available in senior population. Therefore a randomized controlled trial is initiated in our institution compare a senior dedicated fast-track approach to modern standard care after colorectal surgery.
Read the detailed description
BACKROUND:
The multimodal concept of fast-track (FT) surgery was developed by Kehlet et al. in the 1990s to reduce perioperative surgical stress after colorectal surgery, resulting in lower morbidity \& mortality and enhanced recovery.
The main evidence-based FT components include: pain control optimization by epidural or systemic analgesia, short-acting anesthetics, opioids-sparing analgesia, minimally invasive surgery, preoperative carbohydrate administration, normothermia preservation, individualized i.v goal-directed fluids therapy, no bowel preparation, no routine use of drains, nasogastric tube, urinary catheters, early oral nutrition and active ambulation, as well as a dedicated preoperative counseling defining the FT clinical pathway and discharge criteria.
Many cohort studies, randomized controlled trials, meta-analyses and systematic reviews have demonstrated its safety and efficacy for decreasing morbidity, hospital stay, and improving patient satisfaction as compared to standard care (SC).
Only scarce information, mainly based on RetroPro or controlled clinical trials (CCTs), is available on fast-track perioperative care in senior patients (>70 years) as they already represent 15-18% of western population, and over 40% of colorectal surgeries performed at Geneva University Hospital (HUG).
The aim of this randomized controlled trial (RCT) is to compare short-term clinical outcomes of a specifically senior designed fast-track perioperative program versus standard care (SC) after elective colorectal surgery in senior patients.
OBJECTIVES:
30-day postoperative morbidity according to Dindo-Clavien classification of complication is the primary clinical endpoint.
Length of hospital stay (LOS) including readmission, autonomy preservation (through the activities of daily living (ADLs) and instrumental activities of daily living (IADL) scale) and quality of life evaluation are secondary endpoints.
METHOD:
All patients over 70 years requiring elective colorectal surgery will be included in this study after given written informed consent. Exclusion criteria consisted in emergency revisional or liver-associated surgery, and inability to discern/speak French or English. Patients will be 1:1 randomized (institutional table of randomization.
- Conditions
- Colorectal Disorders
- Being tested
- Preoperative Carbohydrate load, individualized i.v fluids therapy, Fasting state after midnight, No Nasogastric tube postoperatively, urinary catheter removal
- Keywords
- Fast-track, multimodal perioperative care, enhanced recovery, colorectal surgery, elderly patients, seniors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Carbohydrate loadDietary supplement
oral intake in the evening before surgery and 2-3h before intubation
individualized i.v fluids therapyProcedure or surgery
by Transoesophageal aortic US-Doppler done intraoperatively
Fasting state after midnightBehavioural
No preoperative glucose load
No Nasogastric tube postoperativelyBehavioural
Withdrawal after complete awakening in operating room
urinary catheter removalBehavioural
at POD 1
Oral liquidsBehavioural
0.3-0.5L oral liquids at 6h postoperatively on POD 0
Stimulation of inspirex utilizationBehavioural
using 6-8 times/day to prevent pulmonary atelectasis
MobilizationBehavioural
First active mobilization 6h after surgery (2h on chair or 45° sitting in bed), >4h out of bed on POD1, >6h on POD2, complete at POD3
Preanesthetic medicationOther
Preanesthetic oral medication before surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Preoperative: Fasting state after midnight, no intake of oral carbohydrate load Preanesthetic medication No preoperative utilization of inspirex Intraoperative: Effective perioperative analgesia Routine nasogastric tube and abdominal drainage at surgeon discretion Postoperative: Removal of the nasogastric tube after return of bowel function removal of abdominal drainage at surgeon discretion or if volume <50cc Oral liquids and stepwise oral nutrition (water to others liquids to progressive normal or low-fiber nutrition Switch to oral medication after oral nutrition tolerance Urinary catheter removal when the mobilization is satisfactory Mobilization: non standardized and encouraged stepwise mobilization Discharge criteria discussed at surgeon discretion Receives: Behavioral: Fasting state after midnight; Other: Preanesthetic medication |
| FT perioperative care | Experimental | Preoperative carbohydrate load No preanesthetic medication General anesthesia and intravenous analgesia Transoesophageal US-Doppler for individualized i.v fluids therapy POD 0: No Nasogastric tube postoperatively Oral liquids 0.3-0.5L 6h after extubation First mobilization 6h after surgery (2h) Stimulation of inspirex utilization (6-8t/d) POD 1: Free oral liquids; progressive normal or low-fiber diet Switch to oral medication Urinary catheter removal Mobilization: >4 h out of bed (walking, chair) inspirex utilization POD 2: Free oral liquids; normal or low-fiber diet Mobilization: >6 h out of bed (walking, chair), inspirex utilization POD 3: Complete mobilization as preoperatively First evaluation of discharge criteria in the afternoon Receives: Dietary Supplement: Preoperative Carbohydrate load; Procedure: individualized i.v fluids therapy; Behavioral: No Nasogastric tube postoperatively; Behavioral: urinary catheter removal; Behavioral: Oral liquids; Behavioral: Stimulation of inspirex utilization; Behavioral: Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day morbidity according to Dindo-Clavien classification
Dindo-Clavien classification of postoperative complication (Grade I to V), including mortality (grade V)
Measured: Postoperative day (POD) 0 to 30
Secondary outcomes (4)
Length of hospital stay (LOS)
LOS: from operating date to discharge
Measured: discharge day
quality of life (QoL)
QoL using a validated questionnaire for digestive surgery (SF-12) 0 to 44 points for 7 items
Measured: POD 0, 30 at 6 and 12 months
readmission
readmission in any hospital for any reason during the 30 postoperative days
Measured: until POD 30
Level of independance
using geriatric functional scale: ADLs(0-6), IADLs (0-7)scoring
Measured: POD 0, 30, at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startDec 2009
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandrine Ostermann, University Hospital, Geneva
- Investigators
- Sandrine Ostermann, MD, PhD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646190
- Sponsor's protocol ID
- NAC 08-060
- Acronym
- FT-SS
- Status last verified
- Jul 2012
- First submitted
- 18 Jul 2012
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15273542Ostermann S, Morel P, Chale JJ, Bucher P, Konrad B, Meier RPH, Ris F, Schiffer ERC. Randomized Controlled Trial of Enhanced Recovery Program Dedicated to Elderly Patients After Colorectal Surgery. Dis Colon Rectum. 2019 Sep;62(9):1105-1116. doi: 10.1097/DCR.0000000000001442.
PubMed 31318772
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast-Track Perioperative Care After Elective Colorectal Surgery in Senior Patients. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01646190
- Acronym / sponsor ID
- FT-SS / NAC 08-060
- Conditions
- Colorectal Disorders
- Keywords
- Fast-track, multimodal perioperative care, enhanced recovery, colorectal surgery, elderly patients, seniors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 20 Jul 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.
Fast-track (FT) surgery is a multimodal, multidisciplinary-team approach to reduce perioperative surgical stress and injury after colorectal surgery, resulting in lower morbidity and enhanced recovery. As fast-track approach could probably be the most beneficial for senior patients to reduce postoperative morbidity and better preserve independency, only scarce information is available in senior population. Therefore a randomized controlled trial is initiated in our institution compare a senior dedicated fast-track approach to modern standard care after colorectal surgery.
Detailed description
BACKROUND:
The multimodal concept of fast-track (FT) surgery was developed by Kehlet et al. in the 1990s to reduce perioperative surgical stress after colorectal surgery, resulting in lower morbidity \& mortality and enhanced recovery.
The main evidence-based FT components include: pain control optimization by epidural or systemic analgesia, short-acting anesthetics, opioids-sparing analgesia, minimally invasive surgery, preoperative carbohydrate administration, normothermia preservation, individualized i.v goal-directed fluids therapy, no bowel preparation, no routine use of drains, nasogastric tube, urinary catheters, early oral nutrition and active ambulation, as well as a dedicated preoperative counseling defining the FT clinical pathway and discharge criteria.
Many cohort studies, randomized controlled trials, meta-analyses and systematic reviews have demonstrated its safety and efficacy for decreasing morbidity, hospital stay, and improving patient satisfaction as compared to standard care (SC).
Only scarce information, mainly based on RetroPro or controlled clinical trials (CCTs), is available on fast-track perioperative care in senior patients (>70 years) as they already represent 15-18% of western population, and over 40% of colorectal surgeries performed at Geneva University Hospital (HUG).
The aim of this randomized controlled trial (RCT) is to compare short-term clinical outcomes of a specifically senior designed fast-track perioperative program versus standard care (SC) after elective colorectal surgery in senior patients.
OBJECTIVES:
30-day postoperative morbidity according to Dindo-Clavien classification of complication is the primary clinical endpoint.
Length of hospital stay (LOS) including readmission, autonomy preservation (through the activities of daily living (ADLs) and instrumental activities of daily living (IADL) scale) and quality of life evaluation are secondary endpoints.
METHOD:
All patients over 70 years requiring elective colorectal surgery will be included in this study after given written informed consent. Exclusion criteria consisted in emergency revisional or liver-associated surgery, and inability to discern/speak French or English. Patients will be 1:1 randomized (institutional table of randomization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Behavioral: Fasting state after midnight, Other: Preanesthetic medicationPreoperative: Fasting state after midnight, no intake of oral carbohydrate load Preanesthetic medication No preoperative utilization of inspirex Intraoperative: Effective perioperative analgesia Routine nasogastric tube and abdominal drainage at surgeon discretion Postoperative: Removal of the nasogastric tube after return of bowel function removal of abdominal drainage at surgeon discretion or if volume <50cc Oral liquids and stepwise oral nutrition (water to others liquids to progressive normal or low-fiber nutrition Switch to oral medication after oral nutrition tolerance Urinary catheter removal when the mobilization is satisfactory Mobilization: non standardized and encouraged stepwise mobilization Discharge criteria discussed at surgeon discretion |
| FT perioperative care | Experimental | Dietary Supplement: Preoperative Carbohydrate load, Procedure: individualized i.v fluids therapy, Behavioral: No Nasogastric tube postoperatively, Behavioral: urinary catheter removal, Behavioral: Oral liquids, Behavioral: Stimulation of inspirex utilization, Behavioral: MobilizationPreoperative carbohydrate load No preanesthetic medication General anesthesia and intravenous analgesia Transoesophageal US-Doppler for individualized i.v fluids therapy POD 0: No Nasogastric tube postoperatively Oral liquids 0.3-0.5L 6h after extubation First mobilization 6h after surgery (2h) Stimulation of inspirex utilization (6-8t/d) POD 1: Free oral liquids; progressive normal or low-fiber diet Switch to oral medication Urinary catheter removal Mobilization: >4 h out of bed (walking, chair) inspirex utilization POD 2: Free oral liquids; normal or low-fiber diet Mobilization: >6 h out of bed (walking, chair), inspirex utilization POD 3: Complete mobilization as preoperatively First evaluation of discharge criteria in the afternoon |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- senior patients (> or = 70 years at operation)
- elective colorectal surgery
Key exclusion criteria (3 listed)
- emergency, liver-associated, revisional surgeries
- inability to discern or speak French/English, dementia
- absolute contraindication to systemic analgesia (severe allergic reaction)
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 |
|---|---|---|
| Preoperative Carbohydrate loadoral intake in the evening before surgery and 2-3h before intubation | Dietary supplement | FT perioperative care |
| individualized i.v fluids therapyby Transoesophageal aortic US-Doppler done intraoperatively | Procedure or surgery | FT perioperative care |
| Fasting state after midnightNo preoperative glucose load | Behavioural | Standard care |
| No Nasogastric tube postoperativelyWithdrawal after complete awakening in operating room | Behavioural | FT perioperative care |
| urinary catheter removalat POD 1 | Behavioural | FT perioperative care |
| Oral liquids0.3-0.5L oral liquids at 6h postoperatively on POD 0 | Behavioural | FT perioperative care |
| Stimulation of inspirex utilizationusing 6-8 times/day to prevent pulmonary atelectasis | Behavioural | FT perioperative care |
| MobilizationFirst active mobilization 6h after surgery (2h on chair or 45° sitting in bed), >4h out of bed on POD1, >6h on POD2, complete at POD3 | Behavioural | FT perioperative care |
| Preanesthetic medicationPreanesthetic oral medication before surgery | Other | Standard care |
Primary outcome
30-day morbidity according to Dindo-Clavien classification
Time frame: Postoperative day (POD) 0 to 30
Dindo-Clavien classification of postoperative complication (Grade I to V), including mortality (grade V)
4 secondary outcomes
Length of hospital stay (LOS)
Time frame: discharge day
quality of life (QoL)
Time frame: POD 0, 30 at 6 and 12 months
readmission
Time frame: until POD 30
Level of independance
Time frame: POD 0, 30, at 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2012.
- Background: PubMed 15273542Dindo 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.
- Derived from this study: PubMed 31318772Ostermann S, Morel P, Chale JJ, Bucher P, Konrad B, Meier RPH, Ris F, Schiffer ERC. Randomized Controlled Trial of Enhanced Recovery Program Dedicated to Elderly Patients After Colorectal Surgery. Dis Colon Rectum. 2019 Sep;62(9):1105-1116. doi: 10.1097/DCR.0000000000001442.
- University Hospital Geneva official website for senior surgeryLink provided by the sponsor.
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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.
Sandrine Ostermann, MD, PhD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Carbohydrate load, individualized i.v fluids therapy and Fasting state after midnight in people with Colorectal Disorders, run by University Hospital, Geneva at 1 site in Switzerland.
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 2 inclusion and 3 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 23 Jul 2012. 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 Switzerland. 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 Sandrine Ostermann, MD, PhD (+41 79 55 34161, sandrine.ostermann@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day morbidity according to Dindo-Clavien classification (time frame: Postoperative day (POD) 0 to 30). 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 NCT01646190, which also lists 2 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 23 Jul 2012.