- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06398678
Anesthesia Management in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Retrospective Evaluation of Anesthesia Management and Clinical Outcomes 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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Şanlıurfa, Turkey, 63050
- University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients who had undergone cytoreductive surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anesthesia Management in Hyperthermic Intraperitoneal Chemotherapy
Time Frame: 01/01/2020 - 01/01/2024
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anaesthesia management in cytoreductive surgery and while hypertermic intraperitoneal chemotherapy
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01/01/2020 - 01/01/2024
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perioperative complications
Time Frame: during the operation
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The potential complications associated with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be identified from the documented records.
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during the operation
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fluid transfusion amounts
Time Frame: during the operation
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The quantity of fluid transfusion administered to the patient during cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be determined from documented records in millilitres.
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during the operation
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blood replacements
Time Frame: during the operation
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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.
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during the operation
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procedure times
Time Frame: during the operation
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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.
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during the operation
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30-day mortality and morbidity
Time Frame: post-operative 30 days
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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.
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post-operative 30 days
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAIEAHANEST
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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