Postoperative Ileus
Conditions
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.
Interventions
PROCEDUREGoal Directed Fluid Therapy (GDFT)-Esophageal doppler guided
Sponsors
Gabriele Baldini, MD, MSc, Assistant Professor
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary postoperative ileus (POI) | participants will be followed for the duration of hospital stay, an expected average of 3 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Participants will be followed for the duration of hospital stay, an expected average of 3 days | Intraoperative opioid administration and postoperative opioid consumption |
| Postoperative nausea and vomiting (PONV) | Participants will be followed for the duration of hospital stay, an expected average of 3 days | — |
| Intraoperative hemodynamic measurements | Participants will be followed for the duration of hospital stay, an expected average of 3 days | 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) |
| 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 | Participants will be followed for the duration of hospital stay, an expected average of 3 days | : 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 |
| Length of hospital stay | 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 | — |
Countries
Canada
Outcome results
None listed