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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Disorders
• Intervention / Treatment: Behavioral: Fasting state after midnight; Other: Preanesthetic medication; Dietary supplement: Preoperative Carbohydrate load; Procedure: individualized i.v fluids therapy; Behavioral: No Nasogastric tube postoperatively; Behavioral: urinary catheter removal; Behavioral: Oral liquids; Behavioral: Stimulation of inspirex utilization; Behavioral: Mobilization

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • University Hospital, Geneva
    • Contact: Sandrine Ostermann, MD, PhD; Phone Number: +41 79 55 34161; Email: sandrine.ostermann@hcuge.ch
    • Contact: Philippe Morel, Pr, Head; Phone Number: +41 22 37 27702; Email: philippe.morel@hcuge.ch
    • Principal Investigator: Sandrine Ostermann, MD, PhD
    • Sub-Investigator: Philippe Morel, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	POD 0 at 6h and 24h, POD 2, POD 3

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Sandrine Ostermann, MD, PhD, University Hospital, Geneva

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• University Hospital Geneva official website for senior surgery

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: July 19, 2012
• First Posted (Estimate): July 20, 2012

Study Record Updates

• Last Update Posted (Estimate): July 23, 2012
• Last Update Submitted That Met QC Criteria: July 20, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: colorectal surgery; elderly patients; Fast-track; enhanced recovery; seniors; multimodal perioperative care
• Other Study ID Numbers: NAC 08-060