Fast-Track Colorectal Surgery in Senior Patients

Colorectal Disorders Clinical Trial

— FT-SS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01646190
• Other study ID #: NAC 08-060
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2012
• Last updated: July 20, 2012
• Start date: December 2009
• Est. completion date: December 2013

Study information

• Verified date: July 2012
• Source: University Hospital, Geneva
• Contact: Sandrine Ostermann, MD, PhD
• Phone: +41 79 55 34161
• Email: sandrine.ostermann[@]hcuge.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Disorders

Intervention

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
• No Nasogastric tube postoperatively
Withdrawal after complete awakening in operating room
• urinary catheter removal
at POD 1
• Oral liquids
0.3-0.5L oral liquids at 6h postoperatively on POD 0
• Stimulation of inspirex utilization
using 6-8 times/day to prevent pulmonary atelectasis
• 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

Locations

Country	Name	City	State
Switzerland	University Hospital, Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain evaluation	Pain score through visual analogue scale (VAS)	POD 0 at 6h and 24h, POD 2, POD 3	No
Other	Fatigue évaluation	Fatigue measured through numeric scale:0 (no fatigue) to 3 (severe) fatigue	POD 0 at 6h and 24h, POD 2, POD 3	No
Primary	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	Yes
Secondary	Length of hospital stay (LOS)	LOS: from operating date to discharge	discharge day	No
Secondary	quality of life (QoL)	QoL using a validated questionnaire for digestive surgery (SF-12) 0 to 44 points for 7 items	POD 0, 30 at 6 and 12 months	No
Secondary	readmission	readmission in any hospital for any reason during the 30 postoperative days	until POD 30	No
Secondary	Level of independance	using geriatric functional scale: ADLs(0-6), IADLs (0-7)scoring	POD 0, 30, at 6 and 12 months	No

External Links

•   University Hospital Geneva official website for senior surgery