Fast-Track Colorectal Surgery in Senior Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Fast-Track Perioperative Care After Elective Colorectal Surgery in Senior Patients. Randomized Controlled Trial

Conditions
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Colorectal Disorders

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br>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<br>* No preoperative glucose load<br>Other: Preanesthetic medication<br>* Preanesthetic oral medication before surgery<br>|
| Experimental: FT perioperative care<br>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<br>* oral intake in the evening before surgery and 2-3h before intubation<br>Procedure: individualized i.v fluids therapy<br>* by Transoesophageal aortic US-Doppler done intraoperatively<br>Behavioral: No Nasogastric tube postoperatively<br>* Withdrawal after complete awakening in operating room<br>Behavioral: urinary catheter removal<br>* at POD 1<br>Behavioral: Oral liquids<br>* 0.3-0.5L oral liquids at 6h postoperatively on POD 0<br>Behavioral: Stimulation of inspirex utilization<br>* using 6-8 times/day to prevent pulmonary atelectasis<br>Behavioral: Mobilization<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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seniors, Fast-track, multimodal perioperative care, enhanced recovery, colorectal surgery, elderly patients