Fast-Track Colorectal Surgery in Senior Patients (FT-SS)
|ClinicalTrials.gov Identifier: NCT01646190|
Recruitment Status : Unknown
Verified July 2012 by Sandrine Ostermann, University Hospital, Geneva.
Recruitment status was: Recruiting
First Posted : July 20, 2012
Last Update Posted : July 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Disorders||Dietary Supplement: Preoperative Carbohydrate load Procedure: individualized i.v fluids therapy Behavioral: Fasting state after midnight Behavioral: No Nasogastric tube postoperatively Behavioral: urinary catheter removal Behavioral: Oral liquids Behavioral: Stimulation of inspirex utilization Behavioral: Mobilization Other: Preanesthetic medication||Not Applicable|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Fast-Track Perioperative Care After Elective Colorectal Surgery in Senior Patients. Randomized Controlled Trial|
|Study Start Date :||December 2009|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Active Comparator: 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
Behavioral: Fasting state after midnight
No preoperative glucose loadOther: Preanesthetic medication
Preanesthetic oral medication before surgery
Experimental: 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
Dietary Supplement: Preoperative Carbohydrate load
oral intake in the evening before surgery and 2-3h before intubationProcedure: individualized i.v fluids therapy
by Transoesophageal aortic US-Doppler done intraoperativelyBehavioral: No Nasogastric tube postoperatively
Withdrawal after complete awakening in operating roomBehavioral: urinary catheter removal
at POD 1Behavioral: Oral liquids
0.3-0.5L oral liquids at 6h postoperatively on POD 0Behavioral: Stimulation of inspirex utilization
using 6-8 times/day to prevent pulmonary atelectasisBehavioral: 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
- 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)
- Length of hospital stay (LOS) [ Time Frame: discharge day ]LOS: from operating date to discharge
- quality of life (QoL) [ Time Frame: POD 0, 30 at 6 and 12 months ]QoL using a validated questionnaire for digestive surgery (SF-12) 0 to 44 points for 7 items
- readmission [ Time Frame: until POD 30 ]readmission in any hospital for any reason during the 30 postoperative days
- Level of independance [ Time Frame: POD 0, 30, at 6 and 12 months ]using geriatric functional scale: ADLs(0-6), IADLs (0-7)scoring
- Pain evaluation [ Time Frame: POD 0 at 6h and 24h, POD 2, POD 3 ]Pain score through visual analogue scale (VAS)
- Fatigue évaluation [ Time Frame: POD 0 at 6h and 24h, POD 2, POD 3 ]Fatigue measured through numeric scale:0 (no fatigue) to 3 (severe) fatigue
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646190
|Contact: Sandrine Ostermann, MD, PhD||+41 79 55 email@example.com|
|Contact: Philippe Morel, Pr, Head||+41 22 37 firstname.lastname@example.org|
|University Hospital, Geneva||Recruiting|
|Geneva, Switzerland, 1211|
|Contact: Sandrine Ostermann, MD, PhD +41 79 55 34161 email@example.com|
|Contact: Philippe Morel, Pr, Head +41 22 37 27702 firstname.lastname@example.org|
|Principal Investigator: Sandrine Ostermann, MD, PhD|
|Sub-Investigator: Philippe Morel, Pr|
|Principal Investigator:||Sandrine Ostermann, MD, PhD||University Hospital, Geneva|