Fast-Track Colorectal Surgery in Senior Patients (FT-SS)

University Hospitals (UH)

Status: Unknown

Conditions: Colorectal Disorders

Treatments: Other: Preanesthetic medication; Procedure: individualized i.v fluids therapy; Behavioral: Oral liquids; Behavioral: No Nasogastric tube postoperatively; Dietary Supplement: Preoperative Carbohydrate load; Behavioral: urinary catheter removal; Behavioral: Stimulation of inspirex utilization; Behavioral: Mobilization; Behavioral: Fasting state after midnight

Study type: Interventional

Funder types: Other

Identifiers

NCT01646190

NAC 08-060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Standard care

Active Comparator group

Description:

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

Treatment:

Other: Preanesthetic medication

Behavioral: Fasting state after midnight

FT perioperative care

Experimental group

Description:

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

Treatment:

Dietary Supplement: Preoperative Carbohydrate load

Behavioral: Mobilization

Behavioral: Oral liquids

Behavioral: Stimulation of inspirex utilization

Behavioral: urinary catheter removal

Behavioral: No Nasogastric tube postoperatively

Procedure: individualized i.v fluids therapy