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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University Hospital, Geneva.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sandrine Ostermann, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01646190
First received: July 18, 2012
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Colorectal Disorders
Dietary Supplement: Preoperative Carbohydrate load
Procedure: individualized i.v fluids therapy
Behavioral: Fasting state after midnight
Behavioral: No Nasogastric tube postoperatively
Behavioral: urinary catheter removal
Behavioral: Oral liquids
Behavioral: Stimulation of inspirex utilization
Behavioral: Mobilization
Other: Preanesthetic medication

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Fast-Track Perioperative Care After Elective Colorectal Surgery in Senior Patients. Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 30-day morbidity according to Dindo-Clavien classification [ Time Frame: Postoperative day (POD) 0 to 30 ] [ Designated as safety issue: Yes ]
    Dindo-Clavien classification of postoperative complication (Grade I to V), including mortality (grade V)


Secondary Outcome Measures:
  • Length of hospital stay (LOS) [ Time Frame: discharge day ] [ Designated as safety issue: No ]
    LOS: from operating date to discharge

  • quality of life (QoL) [ Time Frame: POD 0, 30 at 6 and 12 months ] [ Designated as safety issue: No ]
    QoL using a validated questionnaire for digestive surgery (SF-12) 0 to 44 points for 7 items

  • readmission [ Time Frame: until POD 30 ] [ Designated as safety issue: No ]
    readmission in any hospital for any reason during the 30 postoperative days

  • Level of independance [ Time Frame: POD 0, 30, at 6 and 12 months ] [ Designated as safety issue: No ]
    using geriatric functional scale: ADLs(0-6), IADLs (0-7)scoring


Other Outcome Measures:
  • Pain evaluation [ Time Frame: POD 0 at 6h and 24h, POD 2, POD 3 ] [ Designated as safety issue: No ]
    Pain score through visual analogue scale (VAS)

  • Fatigue évaluation [ Time Frame: POD 0 at 6h and 24h, POD 2, POD 3 ] [ Designated as safety issue: No ]
    Fatigue measured through numeric scale:0 (no fatigue) to 3 (severe) fatigue


Estimated Enrollment: 150
Study Start Date: December 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646190

Contacts
Contact: Sandrine Ostermann, MD, PhD +41 79 55 34161 sandrine.ostermann@hcuge.ch
Contact: Philippe Morel, Pr, Head +41 22 37 27702 philippe.morel@hcuge.ch

Locations
Switzerland
University Hospital, Geneva Recruiting
Geneva, Switzerland, 1211
Contact: Sandrine Ostermann, MD, PhD    +41 79 55 34161    sandrine.ostermann@hcuge.ch   
Contact: Philippe Morel, Pr, Head    +41 22 37 27702    philippe.morel@hcuge.ch   
Principal Investigator: Sandrine Ostermann, MD, PhD         
Sub-Investigator: Philippe Morel, Pr         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Sandrine Ostermann, MD, PhD University Hospital, Geneva
  More Information

Additional Information:
Publications:
Responsible Party: Sandrine Ostermann, Senior Registrar in Digestive Surgery / MD, PhD, swiss board in surgery (FMH), University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01646190     History of Changes
Other Study ID Numbers: NAC 08-060
Study First Received: July 18, 2012
Last Updated: July 20, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
Fast-track
multimodal perioperative care
enhanced recovery
colorectal surgery
elderly patients
seniors

ClinicalTrials.gov processed this record on October 21, 2014