Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis

Study Overview
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Brief Summary
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pulse pressure variation based intraoperative fluid therapy versus traditional fluid therapy for colonic cancer patients undergoing mass resection and anastomosis for maintaining adequate hydration without complications.

Detailed Description
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All Patients will be assigned randomly by using computerized program to one of the two equal groups. Patients will be (forty five patients per group): Group A ;( control group) Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 6 ml/kg/hr. Ringer's solution. Group B; Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation. Intraoperative fluid volume, hemodynamics, serum lactate and intestinal edema will be measured after induction of anesthesia and every hour till the end of the operation, length of the hospital stay, first time to gastrointestinal motion and postoperative complications are recorded.

Official Title
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Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis

Conditions
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Intraoperative Fluid Volume, Hemodynamics, Serum Lactate, Intestinal Edema, Length of the Hospital Stay, First Time to Gastrointestinal Motion, Postoperative Complications

Intervention / Treatment
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* Device: pulse pressure variation
* Other: conventional fluid management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status (ASA-PS) I and II Patients. Patients scheduled for elective open colonic mass resection and anastomosis. Exclusion Criteria: Serious cardiac arrhythmia. Peripheral artery disease. An ejection fraction below 30%. A pulmonary pathology.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conventional fluid management group<br>patients will do elective open colonic mass resection and anastomosis will receive Infusion of 6 ml/kg/hr. Ringer's solution. | Other: conventional fluid management<br>* Infusion of 6 ml/kg/hr. Ringer's solution.<br>|
| Active Comparator: ppv group<br>patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation. | Device: pulse pressure variation<br>* Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative fluid volume |  | calculated immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative blood pressure |  | every ten minutes till the end of the surgery | 
| lactate level |  | every hour till the end of the surgery | 
| POSTOPERATIVE COMPLICATIONS |  | till one week after surgery | 
| intestinal oedema |  | intraoperatively after tumor resection |