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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goal Directed Fluid Therapy (GDFT) | Experimental | During surgery, patients in the Goal Directed Fluid Therapy (GDFT) will receive:
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| Standard Fluid Therapy | Active Comparator | During surgery, patients will receive a maintenance infusion of intravenous infusion of ringer lactate as recommended by international guidelines and anesthesia text-books (Standard Fluid Therapy). In the Standard Fluid Therapy arm, the Esophageal Doppler (ED) monitor will be turned away from the anesthesia care provider, and the screen will be covered with an opaque card. The ED variables will be collected by an independent research personnel. Hemodynamic variables triggering extra fluid administration (Ringer Lactate or Voluven) will be decided based on the clinical judgment of the anesthetist in charge and will include: urinary output less than 0.5/ml/kg/hr, an increase in heart rate more than 20% above baseline or more than 110 beats/min, a decrease in mean systolic blood pressure less than 20% below baseline or less than 90 mmHg and intraoperative blood loss. Boluses of 200 ml of intravenous fluid will be administered until the above targets will be restored |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary postoperative ileus (POI) | Patients will be considered having primary POI if at least one symptom, for each of the following criteria, will be reported: i. vomiting (+/- nausea) OR abdominal distension AND ii. Absence of passing gas/stool OR not tolerating oral diet. | participants will be followed for the duration of hospital stay, an expected average of 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative hemodynamic measurements | Systolic blood pressure; diastolic blood pressure; mean arterial blood pressure; heart rate; flow-time corrected (FTc); stroke distance (SD); Peak velocity (PV); stroke volume (SV); stroke index (SVI); cardiac output (CO); cardiac Index (CI) | Participants will be followed for the duration of hospital stay, an expected average of 3 days |
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Inclusion Criteria:
Exclusion Criteria:
7. Preoperative bowel obstruction 8. Coagulopathies 9. Chronic use of opioids
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal General Hospital | Montreal | Quebec | H3G 1A4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12357146 | Background | 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. | |
| 19837807 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Standard fluid therapy | Other |
|
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| Intraoperative and postoperative fluids and blood products required | Participants will be followed for the duration of hospital stay, an expected average of 3 days |
| Vasoactive agents required | Participants will be followed for the duration of hospital stay, an expected average of 3 days |
| Urinary output | Participants will be followed for the duration of hospital stay, an expected average of 3 days |
| Intraoperative and postoperative urinary output | Participants will be followed for the duration of hospital stay, an expected average of 3 days |
| Intraoperative and Postoperative opioid consumption | Intraoperative opioid administration and postoperative opioid consumption | Participants will be followed for the duration of hospital stay, an expected average of 3 days |
| Postoperative nausea and vomiting (PONV) | Participants will be followed for the duration of hospital stay, an expected average of 3 days |
| Time spent out of bed | Participants will be followed for the duration of hospital stay, an expected average of 3 days |
| Postoperative complications (Clavien Classification) | Participants will be followed for the duration of hospital stay, an expected average of 3 days |
| Patients' weight | Participants will be followed for the duration of hospital stay, an expected average of 3 days |
| Quality of surgical recovery score | Participants will be followed for the duration of hospital stay, an expected average of 3 days |
| Readiness to be discharged | : according to the colorectal pathway, hospital discharge is planned on postoperative day 3. Patients will be discharged if afebrile, able to tolerate oral diet, pain is controlled (NRS < 4), and able to ambulate | Participants will be followed for the duration of hospital stay, an expected average of 3 days |
| Length of hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 3 days |
| 21873370 | Background | 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. |
| 23099039 | Background | 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. |
| 19283742 | Background | 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. |
| 23062720 | Background | 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. |
| D007263 |
| Infusions, Parenteral |