Colorectal Disorders
Conditions
Keywords
Fast-track, multimodal perioperative care, enhanced recovery, colorectal surgery, elderly patients, seniors
Brief 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. 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.
Interventions
oral intake in the evening before surgery and 2-3h before intubation
by Transoesophageal aortic US-Doppler done intraoperatively
No preoperative glucose load
Withdrawal after complete awakening in operating room
at POD 1
0.3-0.5L oral liquids at 6h postoperatively on POD 0
using 6-8 times/day to prevent pulmonary atelectasis
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 oral medication before surgery
Sponsors
Study design
Eligibility
Inclusion criteria
* senior patients (\> or = 70 years at operation) * elective colorectal surgery
Exclusion criteria
* emergency, liver-associated, revisional surgeries * inability to discern or speak French/English, dementia * absolute contraindication to systemic analgesia (severe allergic reaction)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day morbidity according to Dindo-Clavien classification | Postoperative day (POD) 0 to 30 | Dindo-Clavien classification of postoperative complication (Grade I to V), including mortality (grade V) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay (LOS) | discharge day | LOS: from operating date to discharge |
| quality of life (QoL) | 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 | until POD 30 | readmission in any hospital for any reason during the 30 postoperative days |
| Level of independance | POD 0, 30, at 6 and 12 months | using geriatric functional scale: ADLs(0-6), IADLs (0-7)scoring |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain evaluation | POD 0 at 6h and 24h, POD 2, POD 3 | Pain score through visual analogue scale (VAS) |
| Fatigue évaluation | POD 0 at 6h and 24h, POD 2, POD 3 | Fatigue measured through numeric scale:0 (no fatigue) to 3 (severe) fatigue |
Countries
Switzerland