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Completed

NCT Number: NCT01818375

Goal Directed Fluid Therapy and Postoperative Ileus

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.

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Key information

Conditions

Postoperative Ileus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age <18 yr
  • Emergency surgery
  • Patients who do not understand, read or communicate in either French or English
  • Patients who had undergone esophageal or gastric surgery
  • Esophageal pathology (esophageal varices or cancer)
  • Patients with coarctation of the aorta or aortic stenosis
  • Chronic atrial fibrillation
  • Preoperative bowel obstruction 8. Coagulopathies 9. Chronic use of opioids

Treatment and study plan

Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided

Procedure

Other names: Esophageal doppler-Deltex Medical

Standard fluid therapy

Other

Other names: Intravenous infusion as recommended by international guidelines and anesthesia text-books

Primary outcomes

  1. Primary postoperative ileus (POI)

    Time frame: 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 outcomes

  1. Intraoperative hemodynamic measurements

    Time frame: 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)

  2. Intraoperative and postoperative fluids and blood products required

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

  3. Vasoactive agents required

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

  4. Urinary output

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

  5. Intraoperative and postoperative urinary output

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

  6. Intraoperative and Postoperative opioid consumption

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

    Intraoperative opioid administration and postoperative opioid consumption

  7. Postoperative nausea and vomiting (PONV)

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

  8. Time spent out of bed

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

  9. Postoperative complications (Clavien Classification)

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

  10. Patients' weight

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

  11. Quality of surgical recovery score

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

  12. Readiness to be discharged

    Time frame: 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

  13. Length of hospital stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

Sponsors and collaborators

Lead sponsor

Gabriele Baldini, MD, MSc, Assistant Professor

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2013
Registry last updated
Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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