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
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2009-12-31
2013-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Standard care
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
Fasting state after midnight
No preoperative glucose load
Preanesthetic medication
Preanesthetic oral medication before surgery
FT perioperative care
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
Preoperative Carbohydrate load
oral intake in the evening before surgery and 2-3h before intubation
individualized i.v fluids therapy
by Transoesophageal aortic US-Doppler done intraoperatively
No Nasogastric tube postoperatively
Withdrawal after complete awakening in operating room
urinary catheter removal
at POD 1
Oral liquids
0.3-0.5L oral liquids at 6h postoperatively on POD 0
Stimulation of inspirex utilization
using 6-8 times/day to prevent pulmonary atelectasis
Mobilization
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
Interventions
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Preoperative Carbohydrate load
oral intake in the evening before surgery and 2-3h before intubation
individualized i.v fluids therapy
by Transoesophageal aortic US-Doppler done intraoperatively
Fasting state after midnight
No preoperative glucose load
No Nasogastric tube postoperatively
Withdrawal after complete awakening in operating room
urinary catheter removal
at POD 1
Oral liquids
0.3-0.5L oral liquids at 6h postoperatively on POD 0
Stimulation of inspirex utilization
using 6-8 times/day to prevent pulmonary atelectasis
Mobilization
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 medication
Preanesthetic oral medication before surgery
Eligibility Criteria
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Inclusion Criteria
* elective colorectal surgery
Exclusion Criteria
* inability to discern or speak French/English, dementia
* absolute contraindication to systemic analgesia (severe allergic reaction)
70 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Sandrine Ostermann
Senior Registrar in Digestive Surgery / MD, PhD, swiss board in surgery (FMH)
Principal Investigators
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Sandrine Ostermann, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Geneva
Locations
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University Hospital, Geneva
Geneva, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Sandrine Ostermann, MD, PhD
Role: primary
Philippe Morel, Pr, Head
Role: backup
References
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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.
Ostermann 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.
Related Links
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University Hospital Geneva official website for senior surgery
Other Identifiers
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NAC 08-060
Identifier Type: -
Identifier Source: org_study_id