Anesthesia Clinical Trial
Official title:
Retrospective Evaluation of Anesthesia Management and Clinical Outcomes in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
NCT number | NCT06398678 |
Other study ID # | MAIEAHANEST |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2020 |
Est. completion date | January 1, 2024 |
Verified date | May 2024 |
Source | Sanliurfa Mehmet Akif Inan Education and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | January 1, 2024 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital | Sanliurfa |
Lead Sponsor | Collaborator |
---|---|
Sanliurfa Mehmet Akif Inan Education and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anesthesia Management in Hyperthermic Intraperitoneal Chemotherapy | anaesthesia management in cytoreductive surgery and while hypertermic intraperitoneal chemotherapy | 01/01/2020 - 01/01/2024 | |
Primary | perioperative complications | The potential complications associated with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be identified from the documented records. | during the operation | |
Primary | fluid transfusion amounts | The quantity of fluid transfusion administered to the patient during cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be determined from documented records in millilitres. | during the operation | |
Primary | blood replacements | 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. | during the operation | |
Primary | procedure times | 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. | during the operation | |
Primary | 30-day mortality and morbidity | 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. | post-operative 30 days |
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