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Completed

NCT Number: NCT06398678

Anesthesia Management in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

A combined approach of cytoreductive surgery (SRC) and hyperthermic intraperitoneal chemotherapy (HIPEC) represents a potential treatment option for patients diagnosed with primary or secondary gastrointestinal or gynaecological malignancies with peritoneal involvement. While the surgical phase of the operation macroscopically addresses the cancerous tissue, the HIPEC phase targets the microscopic tumour cells that remain after surgery (1). The surgical procedure known as SRC and HIPEC is one of the most complex surgical procedures, presenting numerous challenges for both the surgical and anaesthesia teams. The haemodynamic, haematological and metabolic changes that occur before, during and in the early postoperative period are associated with an increased risk of morbidity and mortality. It is therefore crucial for anaesthesia management to maintain normovolemia during surgery, compensate for hypothermia in the surgical phase and hyperthermia in the HIPEC phase, and maintain metabolic and haemodynamic balance throughout the entire procedure.

The objective of this study was to retrospectively examine the anaesthesia management and clinical outcomes in patients who underwent cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) in order to create literature information that can facilitate the early recognition and prevention of haemodynamic, haematological and metabolic problems that occur especially in the intraoperative and postoperative period.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital

Sanliurfa, 63050, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with primary or secondary gastrointestinal or gynecologic malignancies with peritoneal involvement.
  • Over 18 years of age

Exclusion criteria

  • Over 80 years of age
  • those with heart, lung and liver diseases

Treatment and study plan

Primary outcomes

  1. Anesthesia Management in Hyperthermic Intraperitoneal Chemotherapy

    Time frame: 01/01/2020 - 01/01/2024

    anaesthesia management in cytoreductive surgery and while hypertermic intraperitoneal chemotherapy

  2. perioperative complications

    Time frame: during the operation

    The potential complications associated with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be identified from the documented records.

  3. fluid transfusion amounts

    Time frame: during the operation

    The quantity of fluid transfusion administered to the patient during cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be determined from documented records in millilitres.

  4. blood replacements

    Time frame: during the operation

    The quantity and type of blood and blood products transfused to the patient during cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be determined from documented records in millilitres.

  5. procedure times

    Time frame: during the operation

    The duration of the surgical procedure applied to the patient during cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be determined from the documents recorded in minutes.

  6. 30-day mortality and morbidity

    Time frame: post-operative 30 days

    The morbidity and mortality rate observed in the patient within 30 days of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be quantified as a percentage based on the documented records.

Sponsors and collaborators

Lead sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Other

Registry information

Official study title

Retrospective Evaluation of Anesthesia Management and Clinical Outcomes in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 3, 2024
Registry last updated
May 6, 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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