An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

NCT02754115 | Recruiting DMC

• 1 other identifier: PN 1667
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Ovarian Cancer; Peritoneal Disease

Outcome Measures

Primary Outcomes (4)

• Changes in invasive blood pressure in perioperative period

  Invasive blood pressure will be measured in radial artery in perioperative period and changes from baseline will be recorded in a graphical manner

  From start of surgery upto 48 hours after surgery

• Changes in body temperature in perioperative period

  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

  From start of surgery upto 48 hours after surgery

• Changes in cardiac output in perioperative period

  Cardiac output will be measured in perioperative period and changes from baseline will be recorded in a graphical manner

  From start of surgery upto 48 hours after surgery

• Changes in arterial blood gas in perioperative period

  Arterial blood gases will be measured in perioperative period and changes from baseline will be recorded in a graphical manner

  From start of surgery upto 48 hours after surgery

Secondary Outcomes (2)

• Length of stay in intensive care unit

  Upto 30 days after surgery

• Mortality

  Upto 30 days after surgery

Interventions

Hyperthermic intraperitoneal chemotherapy OTHER

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

American Society of Anesthesiologist class I, II and III patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (1)

• Solanki SL, Agarwal V, Ambulkar RP, Joshi MP, Chawathey S, Rudrappa SP, Bhandare M, Saklani AP. The Hemodynamic Management and Postoperative Outcomes After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: A Prospective Observational Study. Crit Care Res Pract. 2024 Dec 27;2024:8815211. doi: 10.1155/ccrp/8815211. eCollection 2024.

  PMID: 39760061 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Ovarian Neoplasms; Peritoneal Diseases

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Sohan L solanki

  Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sohan L Solanki, MD

CONTACT

+919869253201; me_sohans@yahoo.co.in

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesiology, Critical Care and Pain

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 28, 2016
• Study Start: April 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)