Restrictive or Individualized Goal-Directed Fluid Replacement Strategy in Ovarian Cancer Cytoreductive Surgery (RIGoROCS)
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|ClinicalTrials.gov Identifier: NCT03519165|
Recruitment Status : Completed
First Posted : May 8, 2018
Last Update Posted : January 31, 2020
This is a single center prospective randomized controlled study comparing the postoperative outcome after cytoreductive surgery in ovarian cancer patient after using restrictive or individualized goal-directed fluid replacement strategy (GDT). Aim of this study will be to test the hypothesis that intra-operative SVV-guided fluid optimization during ovarian cancer cytoreductive surgery:
- reduces the postoperative length of hospital stay,
- GDT will be more beneficial in cases of PDS compared to IDS or cytoreductive procedures of shorter duration.
- GDT improves intraoperative tissue perfusion/ oxygenation and improves immediate postoperative morbidity.
Intra-operatively fluid of choice in both groups will be lactate-free crystalloid at 1.0 ml/kg/h for maintenance and gelofusine for fluid bolus of 3ml/kg over 5 minutes. In group C intraoperative fluid therapy will include maintenance fluid and replacement of the surgical loss. Aim will be to maintain MAP > 65 mmHg, CVP 8-12 cm H2O and urine output > 0.5 ml/kg/h. In group G intraoperative fluid therapy will be targeted to SVV <13%, SVI > 35ml/m2/ beat, SVRI more than equal to 1900 dynes-sec/cm-5/m2 in addition to clinical parameters like MAP, CVP and urine output.
Primary outcome will be length of hospital stay (LOS). Secondary outcomes will be cost of surgical treatment episode (admission till fit to discharge), postoperative morbidity survey (POMS) and 30 day morbidity and mortality.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Device: EV1000(FloTrac System 4.0)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||145 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Flotrac System 4.0 Edwards Lifesciences, Irvine, CA, USA|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Restrictive or Individualized Goal-Directed Fluid Replacement Strategy in Ovarian Cancer Cytoreductive Surgery- A Prospective Randomized Controlled Trial|
|Actual Study Start Date :||June 2016|
|Actual Primary Completion Date :||June 2019|
|Actual Study Completion Date :||September 2019|
No Intervention: Control group (Group C)
Conventional Fluid therapy guided by clinical parameter
Intraoperative fluid therapy will include maintenance fluid and replacement of the surgical loss. Aim to maintain MAP > 65 mmHg, CVP 8-12 cm H2O and urine output > 0.5 ml/kg/h.
Active Comparator: Goal directed group (Group G)
Intervention: Machine guided fluid therapy using EV1000 (FloTrac System 4.0 Edward Lifesciences, Irvine, CA, USA)
Intraoperative fluid therapy will be targeted to SVV <13%, SVI > 35ml/m2/ beat, SVRI more than equal to 1900 dynes-sec/cm-5/m2 using EV1000 floTrac monitor in addition to clinical parameters like MAP, CVP and urine output
Device: EV1000(FloTrac System 4.0)
- Postoperative length of Stay (LOS) in hospital in days [ Time Frame: through study completion, an average of 2 years ]From day of surgery to the day of fit to discharge
- Cost of treatment [ Time Frame: through study completion, an average of 2 years ]cost of treatment includes direct medical cost and out of pocket expenditure
- Post operative morbidity survey (POMS survey) [ Time Frame: on 1,3,5 and 7th postoperative day and through study completion, an average of 2 years ]The postoperative morbidity survey (POMS) is a nine-domain (Pulmonary, infection, renal, GIT, CVS, Neurological, haematological, wound and pain) system that prospectively identifies short-term morbidity after surgery. For each of the nine domains morbidity is recorded on the presence or absence of preset criteria.(PubMed ID: 10439777)
- 30 day morbidity and mortality [ Time Frame: through study completion, an average of 2 years ]No. of patients in each group with grade 3 to 5 postoperative complications (Clavien-Dindo Classification) and description of complication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519165
|Tata Medical Centre|
|Kolkata, West Bengal, India, 700156|
|Principal Investigator:||Jyotsna Goswami, MD||Tata Medical Center|
|Principal Investigator:||Asima Mukhopadhyay, MD, PHD||Tata Medical Center|