Clinical trial NCT01646190: Fast-Track Colorectal Surgery in Senior Patients
Official title: Fast-Track Perioperative Care After Elective Colorectal Surgery in Senior Patients. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Disorders
Keywords: Fast-track
multimodal perioperative care
enhanced recovery
colorectal surgery
elderly patients
seniors
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 150
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 30-day morbidity according to Dindo-Clavien classification
timeFrame: Postoperative day (POD) 0 to 30
Secondary outcomes:
measure: Length of hospital stay (LOS)
timeFrame: discharge day
measure: quality of life (QoL)
timeFrame: POD 0, 30 at 6 and 12 months
measure: readmission
timeFrame: until POD 30
measure: Level of independance
timeFrame: POD 0, 30, at 6 and 12 months
Other outcomes:
measure: Pain evaluation
timeFrame: POD 0 at 6h and 24h, POD 2, POD 3
measure: Fatigue évaluation
timeFrame: POD 0 at 6h and 24h, POD 2, POD 3
Locations:
city: Geneva
country: Switzerland
facility: University Hospital, Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Sandrine Ostermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.