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NCT Number: NCT02754115

An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

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.

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Key information

Conditions

Colorectal Cancer Adnexal Diseases Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Peritoneal Disease Peritoneal Diseases Rectal Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location status: Recruiting

Location contact

Sohan L solanki, MD

CONTACT

[email protected]

9869253201

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age less than 18 and more than 70 years
  • ASA Class IV and above

Treatment and study plan

Hyperthermic intraperitoneal chemotherapy

Other

Perioperative data of all the patients posted for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be collected prospectively

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Sohan L Solanki, MD

CONTACT

[email protected]

+919869253201

Sponsors and collaborators

Lead sponsor

Tata Memorial Centre

Other

Registry information

Official study title

A Prospective Audit of Perioperative Parameters of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC)

Important dates

Study start
2016
Primary completion
2026
Study completion
2027
First posted
Apr 28, 2016
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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