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Fast-Track Colorectal Surgery in Senior Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01646190
Acronym
FT-SS
Enrollment
150
Registered
2012-07-20
Start date
2009-12-31
Completion date
2013-12-31
Last updated
2012-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Disorders

Keywords

Fast-track, multimodal perioperative care, enhanced recovery, colorectal surgery, elderly patients, seniors

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.

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.

Interventions

DIETARY_SUPPLEMENTPreoperative Carbohydrate load

oral intake in the evening before surgery and 2-3h before intubation

PROCEDUREindividualized i.v fluids therapy

by Transoesophageal aortic US-Doppler done intraoperatively

BEHAVIORALFasting state after midnight

No preoperative glucose load

BEHAVIORALNo Nasogastric tube postoperatively

Withdrawal after complete awakening in operating room

at POD 1

BEHAVIORALOral liquids

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

BEHAVIORALStimulation of inspirex utilization

using 6-8 times/day to prevent pulmonary atelectasis

BEHAVIORALMobilization

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

OTHERPreanesthetic medication

Preanesthetic oral medication before surgery

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
30-day morbidity according to Dindo-Clavien classificationPostoperative day (POD) 0 to 30Dindo-Clavien classification of postoperative complication (Grade I to V), including mortality (grade V)

Secondary

MeasureTime frameDescription
Length of hospital stay (LOS)discharge dayLOS: from operating date to discharge
quality of life (QoL)POD 0, 30 at 6 and 12 monthsQoL using a validated questionnaire for digestive surgery (SF-12) 0 to 44 points for 7 items
readmissionuntil POD 30readmission in any hospital for any reason during the 30 postoperative days
Level of independancePOD 0, 30, at 6 and 12 monthsusing geriatric functional scale: ADLs(0-6), IADLs (0-7)scoring

Other

MeasureTime frameDescription
Pain evaluationPOD 0 at 6h and 24h, POD 2, POD 3Pain score through visual analogue scale (VAS)
Fatigue évaluationPOD 0 at 6h and 24h, POD 2, POD 3Fatigue measured through numeric scale:0 (no fatigue) to 3 (severe) fatigue

Countries

Switzerland

Contacts

Primary ContactSandrine Ostermann, MD, PhD
sandrine.ostermann@hcuge.ch+41 79 55 34161
Backup ContactPhilippe Morel, Pr, Head
philippe.morel@hcuge.ch+41 22 37 27702

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026