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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

Tracking Information
First Submitted Date March 29, 2016
First Posted Date April 28, 2016
Last Update Posted Date September 12, 2018
Actual Study Start Date April 2016
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2016)
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02754115 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 25, 2016)
  • 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
  • Mortality [ Time Frame: Upto 30 days after surgery ]
    30 days mortality will be noted if death occurred within this period
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Official Title A Prospective Audit of Perioperative Parameters of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population American Society of Anesthesiologist class I, II and III patients
Condition
  • Colorectal Cancer
  • Ovarian Cancer
  • Peritoneal Disease
Intervention Other: Hyperthermic intraperitoneal chemotherapy
Perioperative data of all the patients posted for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be collected prospectively
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 25, 2016)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sohan L Solanki, MD +919869253201 me_sohans@yahoo.co.in
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT02754115
Other Study ID Numbers PN 1667
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Sohan Lal Solanki, Tata Memorial Centre
Study Sponsor Tata Memorial Centre
Collaborators Not Provided
Investigators
Principal Investigator: Sohan L solanki Tata Memorial Centre
PRS Account Tata Memorial Centre
Verification Date September 2018