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Trial record 12 of 597 for:    Recruiting, Not yet recruiting, Available Studies | Ovarian cancer

Restrictive or Individualized Goal-Directed Fluid Replacement Strategy in Ovarian Cancer Cytoreductive Surgery (RIGoROCS)

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ClinicalTrials.gov Identifier: NCT03519165
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Tata Medical Center

Brief Summary:

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:

  1. reduces the postoperative length of hospital stay,
  2. cost-effective,
  3. GDT will be more beneficial in cases of PDS compared to IDS or cytoreductive procedures of shorter duration.
  4. 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) Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Flotrac System 4.0 Edwards Lifesciences, Irvine, CA, USA
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Restrictive or Individualized Goal-Directed Fluid Replacement Strategy in Ovarian Cancer Cytoreductive Surgery- A Prospective Randomized Controlled Trial
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cytoreductive surgery for ovarian cancer-

    • PDS: primary (chemo-naïve patients including completion staging/ primary debulking and secondary cytoreduction)
    • IDS: interval debulking surgery (after chemotherapy)
  • American Society of Anesthesiology (ASA-PS) score of 1 - 3
  • Age more than 18 years and less than 65 years
  • Surgery of duration more than 240 minutes
  • Presumed blood loss more than 500 ml
  • Elective surgery

Exclusion Criteria:

  • Patient refusal
  • Inability to give consent
  • Laparoscopic surgery, Emergency surgery, patients undergoing HIPEC
  • Age younger than 18 years & more than 65 yrs, BMI > 40
  • Patients with LVEF < 30%, Arrhythmia, Acute MI (within 30 days)
  • COPD with FEV1 < 50%
  • Coagulopathy (platelet <50000/μL, aPTT > x2 control, INR >1.5)
  • Significant liver dysfunction (liver enzymes >x3 times normal)
  • Significant renal dysfunction (creatinine >x2 times normal)
  • Psychiatric disorders
  • Sepsis or SIRS
  • Hypersensitivity to Gelofusine

Information from the National Library of Medicine

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


Contacts
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Contact: Jyotsna Goswami, MD 03366057000 ext 7179 jyotsnagoswami@gmail.com
Contact: Asima Mukhopadhyay, MD, PHD 03366057000 ext 7258 asima7@yahoo.co.in

Locations
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India
Tata Medical Centre Recruiting
Kolkata, West Bengal, India, 700156
Contact: Sanjoy Chatterjee, MRCP,FRCR    9038161825    sanjoy.chatterjee@tmckolkata.com   
Sponsors and Collaborators
Tata Medical Center
Investigators
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Principal Investigator: Jyotsna Goswami, MD Tata Medical Center
Principal Investigator: Asima Mukhopadhyay, MD, PHD Tata Medical Center

Publications:
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Responsible Party: Tata Medical Center
ClinicalTrials.gov Identifier: NCT03519165     History of Changes
Other Study ID Numbers: EC/TMC/56/15
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Tata Medical Center:
Ovarian cancer
goal-directed fluid therapy
SVV
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma