Clinical trial NCT01818375: Goal Directed Fluid Therapy and Postoperative Ileus
Official title: Goal-directed Fluid Therapy and Postoperative Ileus After Elective Laparoscopic Colorectal Surgery Using an Enhanced Recovery Program: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Ileus
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Despite Goal Directed Fluid Therapy (GDFT) has shown a reduction of hospitalization and overall complications in patients undergoing abdominal surgery, there is a need to address the effect of implementing GDFT on the incidence of specific surgical complications and in a context of en enhanced recovery program (ERP). Specifically, studies investigating the impact of GDFT on primary postoperative ileus (POI) in patients undergoing laparoscopic colorectal surgery and using an ERP are missing.

It is hypothesized that the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving Standard Fluid Therapy (SFT) after elective laparoscopic colorectal surgeries with an ERP program.

Detailed description: Randomized Controlled Trial. Study population: elective laparoscopic colorectal resections with an Enhanced Recovery Program (ERP) Sample size: 128 patients (140 accounting for drops out)

Two arms:

GDFT: patients will receive GDFT esophageal doppler guided; SFT: patients will receive SFT based on standard anesthesia formula and international guidelines to calculate fluid requirements.

Study Hypothesis: the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving SFT after elective laparoscopic colorectal surgeries with an ERP program.

ERP: all patients will receive the same perioperative care according to the Enhanced Recovery After Surgery ERAS® program guidelines. Intravenous fluid will be stopped the first day after surgery. Patients will be allowed to have clear fluids the same day of surgery and diet, as tolerated, the first day after surgery.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing elective laparoscopic colorectal resection with an Enhanced Recovery Program

Exclusion Criteria:

1. Age \<18 yr
2. Emergency surgery
3. Patients who do not understand, read or communicate in either French or English
4. Patients who had undergone esophageal or gastric surgery
5. Esophageal pathology (esophageal varices or cancer)
6. Patients with coarctation of the aorta or aortic stenosis
7. Chronic atrial fibrillation

7. Preoperative bowel obstruction 8. Coagulopathies 9. Chronic use of opioids

Primary outcomes:
measure: Primary postoperative ileus (POI)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes:
measure: Intraoperative hemodynamic measurements
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Intraoperative and postoperative fluids and blood products required
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Vasoactive agents required
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Urinary output
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Intraoperative and postoperative urinary output
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Intraoperative and Postoperative opioid consumption
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Postoperative nausea and vomiting (PONV)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Time spent out of bed
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Postoperative complications (Clavien Classification)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Patients' weight
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Quality of surgical recovery score
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Readiness to be discharged
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Length of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
References:
citation: Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
citation: Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
citation: Challand C, Struthers R, Sneyd JR, Erasmus PD, Mellor N, Hosie KB, Minto G. Randomized controlled trial of intraoperative goal-directed fluid therapy in aerobically fit and unfit patients having major colorectal surgery. Br J Anaesth. 2012 Jan;108(1):53-62. doi: 10.1093/bja/aer273. Epub 2011 Aug 26.
citation: Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, MacFie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28.
citation: Rahbari NN, Zimmermann JB, Schmidt T, Koch M, Weigand MA, Weitz J. Meta-analysis of standard, restrictive and supplemental fluid administration in colorectal surgery. Br J Surg. 2009 Apr;96(4):331-41. doi: 10.1002/bjs.6552.
citation: Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):801-16. doi: 10.1016/j.clnu.2012.08.012. Epub 2012 Sep 26.