Fast-Track Colorectal Surgery in Senior Patients
FT-SS
Fast-Track Perioperative Care After Elective Colorectal Surgery in Senior Patients. Randomized Controlled Trial
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 18, 2012
CompletedFirst Posted
Study publicly available on registry
July 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJuly 23, 2012
July 1, 2012
4 years
July 18, 2012
July 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Length of hospital stay (LOS)
discharge day
quality of life (QoL)
POD 0, 30 at 6 and 12 months
readmission
until POD 30
Level of independance
POD 0, 30, at 6 and 12 months
Other Outcomes (2)
Pain evaluation
POD 0 at 6h and 24h, POD 2, POD 3
Fatigue évaluation
POD 0 at 6h and 24h, POD 2, POD 3
Study Arms (2)
Standard care
ACTIVE COMPARATORPreoperative: 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
FT perioperative care
EXPERIMENTALPreoperative 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
Interventions
oral intake in the evening before surgery and 2-3h before intubation
by Transoesophageal aortic US-Doppler done intraoperatively
Withdrawal after complete awakening in operating room
using 6-8 times/day to prevent pulmonary atelectasis
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
Eligibility Criteria
You may qualify if:
- senior patients (\> or = 70 years at operation)
- elective colorectal surgery
You may not qualify if:
- emergency, liver-associated, revisional surgeries
- inability to discern or speak French/English, dementia
- absolute contraindication to systemic analgesia (severe allergic reaction)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital, Geneva
Geneva, 1211, Switzerland
Related Publications (2)
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.
PMID: 15273542BACKGROUNDOstermann 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.
PMID: 31318772DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandrine Ostermann, MD, PhD
University Hospital, Geneva
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Registrar in Digestive Surgery / MD, PhD, swiss board in surgery (FMH)
Study Record Dates
First Submitted
July 18, 2012
First Posted
July 20, 2012
Study Start
December 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
July 23, 2012
Record last verified: 2012-07