Goal Directed Fluid Therapy and Postoperative Ileus

Postoperative Ileus Clinical Trial

Official title: Goal-directed Fluid Therapy and Postoperative Ileus After Elective Laparoscopic Colorectal Surgery Using an Enhanced Recovery Program: a Randomized Controlled Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

• NCT number: NCT01818375
• Study type: Interventional
• Source: McGill University Health Center
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Completion date: August 2015