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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818375
• Other study ID #: 12-277-SDR
• Status: Completed
• Phase: N/A
• First received: March 21, 2013
• Last updated: October 1, 2015
• Start date: February 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Procedure:
• Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided

Other:
• Standard fluid therapy

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Gabriele Baldini, MD, MSc, Assistant Professor

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View 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. — View 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. Review. — View 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®) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28. Review. — View 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®) Society recommendations. Clin Nutr. 2012 Dec;31(6):801-16. doi: 10.1016/j.clnu.2012.08.012. Epub 2012 Sep 26. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Intraoperative and postoperative fluids and blood products required		Participants will be followed for the duration of hospital stay, an expected average of 3 days	No
Secondary	Vasoactive agents required		Participants will be followed for the duration of hospital stay, an expected average of 3 days	No
Secondary	Urinary output		Participants will be followed for the duration of hospital stay, an expected average of 3 days	No
Secondary	Intraoperative and postoperative urinary output		Participants will be followed for the duration of hospital stay, an expected average of 3 days	No
Secondary	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	No
Secondary	Postoperative nausea and vomiting (PONV)		Participants will be followed for the duration of hospital stay, an expected average of 3 days	No
Secondary	Time spent out of bed		Participants will be followed for the duration of hospital stay, an expected average of 3 days	No
Secondary	Postoperative complications (Clavien Classification)		Participants will be followed for the duration of hospital stay, an expected average of 3 days	No
Secondary	Patients' weight		Participants will be followed for the duration of hospital stay, an expected average of 3 days	No
Secondary	Quality of surgical recovery score		Participants will be followed for the duration of hospital stay, an expected average of 3 days	No
Secondary	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	No
Secondary	Length of hospital stay		Participants will be followed for the duration of hospital stay, an expected average of 3 days	No

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