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An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

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ClinicalTrials.gov Identifier: NCT02754115
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Sohan Lal Solanki, Tata Memorial Centre

Brief Summary:

Peritoneal carcinomatosis is a common event in the natural history of colorectal and other digestive tract cancers. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) provides a promising therapeutic option for highly selected patients with peritoneal carcinomatosis arising from different malignancies such as colorectal cancer, gastric cancer, ovarian cancer, or peritoneal mesothelioma with improvement of both patient survival and quality of life. CRS, i.e., removal of all visible metastatic abdominal and pelvic disease with peritonectomy along with HIPEC (for 90 min at a temperature of 42º C) and/or early postoperative intraperitoneal chemotherapy (EPIC) in order to eradicate all microscopic metastasis.

CRS with HIPEC is a long and complex procedure with significant blood and fluid loss during debulking, hemodynamic, hematological, and metabolic alterations before and during the HIPEC phase, and even in the early postoperative period, with resultant significant morbidity and mortality. Despite that most of the reported patients are in American Society of Anesthesiologist class I and II, without significant comorbidities or systemic disorder; the morbidity and mortality ranges from 12 to 65% in these procedures, so a well coordinated team of anesthesiologist, surgeons and intensivist and other ancillary services can result in good outcome. This study will see the challenges faced by the team regarding the pathophysiological alterations during the CRS with HIPEC in the perioperative period.


Condition or disease Intervention/treatment
Colorectal Cancer Ovarian Cancer Peritoneal Disease Other: Hyperthermic intraperitoneal chemotherapy

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Audit of Perioperative Parameters of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC)
Actual Study Start Date : April 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever


Intervention Details:
  • Other: Hyperthermic intraperitoneal chemotherapy
    Perioperative data of all the patients posted for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be collected prospectively


Primary Outcome Measures :
  1. Changes in invasive blood pressure in perioperative period [ Time Frame: From start of surgery upto 48 hours after surgery ]
    Invasive blood pressure will be measured in radial artery in perioperative period and changes from baseline will be recorded in a graphical manner

  2. Changes in body temperature in perioperative period [ Time Frame: From start of surgery upto 48 hours after surgery ]
    Body temperature will be measured in degree centigrade by nasopharyngeal temperature probe in perioperative period and changes from baseline will be recorded in a graphical manner

  3. Changes in cardiac output in perioperative period [ Time Frame: From start of surgery upto 48 hours after surgery ]
    Cardiac output will be measured in perioperative period and changes from baseline will be recorded in a graphical manner

  4. Changes in arterial blood gas in perioperative period [ Time Frame: From start of surgery upto 48 hours after surgery ]
    Arterial blood gases will be measured in perioperative period and changes from baseline will be recorded in a graphical manner


Secondary Outcome Measures :
  1. Length of stay in intensive care unit [ Time Frame: Upto 30 days after surgery ]
    Length of stay will be measured in days from admission to discharge in intensive care unit

  2. Mortality [ Time Frame: Upto 30 days after surgery ]
    30 days mortality will be noted if death occurred within this period



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
American Society of Anesthesiologist class I, II and III patients
Criteria

Inclusion Criteria:

  1. Age between 18 to 70 years
  2. ASA Class I to III
  3. Colorectal and gynecological oncology cases posted for CRS with HIPC.

Exclusion Criteria:

  1. Age less than 18 and more than 70 years
  2. ASA Class IV and above

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): NCT02754115


Contacts
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Contact: Sohan L Solanki, MD +919869253201 me_sohans@yahoo.co.in

Locations
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India
Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Sohan L solanki, MD    9869253201    me_sohans@yahoo.co.in   
Sponsors and Collaborators
Tata Memorial Centre
Investigators
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Principal Investigator: Sohan L solanki Tata Memorial Centre

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Responsible Party: Sohan Lal Solanki, Assistant Professor, Department of Anesthesiology, Critical Care and Pain, Tata Memorial Centre
ClinicalTrials.gov Identifier: NCT02754115     History of Changes
Other Study ID Numbers: PN 1667
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Peritoneal Diseases
Digestive System Diseases