NCT06398678

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

4 years

First QC Date

May 1, 2024

Last Update Submit

May 3, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Anesthesia Management in Hyperthermic Intraperitoneal Chemotherapy

    anaesthesia management in cytoreductive surgery and while hypertermic intraperitoneal chemotherapy

    01/01/2020 - 01/01/2024

  • perioperative complications

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

    during the operation

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Patients who had undergone cytoreductive surgery.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include cases of patients over the age of 18 who underwent hyperthermic intraperitoneal chemotherapy with the closed method in accordance with the protocols determined by the Department of Surgical Oncology for 4 years retrospectively at the University of Health Sciences Şanlıurfa Mehmet Akif İnan Health Application and Research Center.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Sanliurfa, 63050, Turkey (Türkiye)

Location

Related Publications (1)

  • Kaya A, Karahan MA. Retrospective evaluation of anesthesia management and clinical outcomes in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. BMC Anesthesiol. 2025 Jul 30;25(1):369. doi: 10.1186/s12871-025-03241-5.

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

May 1, 2024

First Posted

May 3, 2024

Study Start

January 1, 2020

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

May 6, 2024

Record last verified: 2024-05

Locations