FT-SS: Fast-Track Colorectal Surgery in Senior Patients

Sponsor

University Hospital, Geneva (Other)

Overall Status

Unknown status

CT.gov ID

NCT01646190

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

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 :

Dec 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 load Other: 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 intubation Procedure: individualized i.v fluids therapy by Transoesophageal aortic US-Doppler done intraoperatively Behavioral: No Nasogastric tube postoperatively Withdrawal after complete awakening in operating room Behavioral: urinary catheter removal at POD 1 Behavioral: Oral liquids 0.3-0.5L oral liquids at 6h postoperatively on POD 0 Behavioral: Stimulation of inspirex utilization using 6-8 times/day to prevent pulmonary atelectasis Behavioral: 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

Arm

Intervention/Treatment

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 load

Other: 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 intubation

Procedure: individualized i.v fluids therapy

by Transoesophageal aortic US-Doppler done intraoperatively

Behavioral: No Nasogastric tube postoperatively

Withdrawal after complete awakening in operating room

Behavioral: urinary catheter removal

at POD 1

Behavioral: Oral liquids

0.3-0.5L oral liquids at 6h postoperatively on POD 0

Behavioral: Stimulation of inspirex utilization

using 6-8 times/day to prevent pulmonary atelectasis

Behavioral: 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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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