NCT01646190

Fast-Track Colorectal Surgery in Senior Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Disorders

Interventions

Type	Name	Description
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	Fasting state after midnight	No preoperative glucose load
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
OTHER	Preanesthetic medication	Preanesthetic oral medication before surgery

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-07-20
• Last updated: 2012-07-23

Locations

1 site across 1 country: Switzerland