Cytoreductive SurgeryNCT06398678
Anesthesia Management in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
An observational study of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cytoreductive Surgery, Hyperthermic Intraperitoneal Chemotherapy, Anesthesia
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients with primary or secondary gastrointestinal or gynecologic malignancies with peritoneal involvement.
- Over 18 years of age
Who cannot join
- Over 80 years of age
- those with heart, lung and liver diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital
Sanliurfa, 63050
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who had undergone cytoreductive surgery. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia Management in Hyperthermic Intraperitoneal Chemotherapy
anaesthesia management in cytoreductive surgery and while hypertermic intraperitoneal chemotherapy
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: post-operative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Jan 2020
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytoreductive SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmet kaya, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398678
- Sponsor's protocol ID
- MAIEAHANEST
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40739475
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Anesthesia Management and Clinical Outcomes in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
- ClinicalTrials.gov ID
- NCT06398678
- Acronym / sponsor ID
- MAIEAHANEST
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who had undergone cytoreductive surgery. | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients with primary or secondary gastrointestinal or gynecologic malignancies with peritoneal involvement.
- Over 18 years of age
Key exclusion criteria (2 listed)
- Over 80 years of age
- those with heart, lung and liver diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anesthesia Management in Hyperthermic Intraperitoneal Chemotherapy
Time frame: 01/01/2020 - 01/01/2024
anaesthesia management in cytoreductive surgery and while hypertermic intraperitoneal chemotherapy
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Derived from this study: PubMed 40739475Kaya 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthesia Management in Hyperthermic Intraperitoneal Chemotherapy (time frame: 01/01/2020 - 01/01/2024). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06398678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.