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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative Carbohydrate load | Dietary Supplement | oral intake in the evening before surgery and 2-3h before intubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day morbidity according to Dindo-Clavien classification | Dindo-Clavien classification of postoperative complication (Grade I to V), including mortality (grade V) | Postoperative day (POD) 0 to 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay (LOS) | LOS: from operating date to discharge | discharge day |
| quality of life (QoL) | QoL using a validated questionnaire for digestive surgery (SF-12) 0 to 44 points for 7 items |
| Measure | Description | Time Frame |
|---|---|---|
| Pain evaluation | Pain score through visual analogue scale (VAS) | POD 0 at 6h and 24h, POD 2, POD 3 |
| Fatigue évaluation | Fatigue measured through numeric scale:0 (no fatigue) to 3 (severe) fatigue |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandrine Ostermann, MD, PhD | Contact | +41 79 55 34161 | sandrine.ostermann@hcuge.ch | |
| Philippe Morel, Pr, Head | Contact | +41 22 37 27702 | philippe.morel@hcuge.ch |
| Name | Affiliation | Role |
|---|---|---|
| Sandrine Ostermann, MD, PhD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Geneva | Recruiting | Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15273542 | Background | 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. | |
| 31318772 | Derived | 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. |
| Label | URL |
|---|---|
| University Hospital Geneva official website for senior surgery | View source |
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| individualized i.v fluids therapy | Procedure | by Transoesophageal aortic US-Doppler done intraoperatively |
|
| Fasting state after midnight | Behavioral | No preoperative glucose load |
|
| No Nasogastric tube postoperatively | Behavioral | Withdrawal after complete awakening in operating room |
|
| urinary catheter removal | Behavioral | at POD 1 |
|
| Oral liquids | Behavioral | 0.3-0.5L oral liquids at 6h postoperatively on POD 0 |
|
| Stimulation of inspirex utilization | Behavioral | using 6-8 times/day to prevent pulmonary atelectasis |
|
| Mobilization | Behavioral | 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 | Other | Preanesthetic oral medication before surgery |
|
| POD 0, 30 at 6 and 12 months |
| readmission | readmission in any hospital for any reason during the 30 postoperative days | until POD 30 |
| Level of independance | using geriatric functional scale: ADLs(0-6), IADLs (0-7)scoring | POD 0, 30, at 6 and 12 months |
| POD 0 at 6h and 24h, POD 2, POD 3 |
| ID | Term |
|---|---|
| D005440 | Fluid Therapy |
| D011229 | Preanesthetic Medication |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011300 | Preoperative Care |
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D000760 | Anesthesia and Analgesia |
| D013514 | Surgical Procedures, Operative |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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