Major Gynecological Cancer SurgeryNCT06636448
The Relationship Between Body Mass Index and Patient Outcomes in Low Flow Anaesthesia
An observational study of Major Gynecological Cancer Surgery and Low Flow Anesthesia, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study was designed as a prospective observational study. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Major Gynecological Cancer Surgery, Low Flow Anesthesia
- What is being tested?
- the effect of body mass index during low-flow anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Mar 2025
- How long will I take part?
- 1 Day
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 40 patients were planned for this study
Who may be able to join
- Patients with ASA II-III
- \>18 years
- Patients undergoing major open surgery for endometrium, cervix or ovarian ca in gynaecological oncology clinic
Who cannot join
- Patients who refused to participate in the study
- Cerebrovascular disease
- Those with severe pulmonary disease
- Those with serious cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Body Mass Index on Patient Outcomes During Low-flow Anaesthesia for Major Gynaecological Cancer Surgery: a Prospective Observational Study
This study was designed as a prospective observational study.
Read the detailed description
In this study, it was planned to evaluate the effect of body mass index on patient outcomes during low flow anaesthesia in patients undergoing gynaecological cancer surgery on the specified dates. ASA II and III patients over 18 years of age were included in the study. Low flow anaesthesia is routinely applied in open gynaecological cancer surgeries in our clinic. The relationship between body mass index and intraoperative haemodynamic and mechanical ventilator values and postoperative patient outcomes will be evaluated.
- Being tested
- the effect of body mass index during low-flow anesthesia
- Keywords
- major gynecological cancer surgery, low flow aneshesia, cerebral oxygenation, hypoxia
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the effect of body mass index during low-flow anesthesiaProcedure or surgery
The investigator planned to evaluate the effect of body mass index on patient outcomes during low-flow anesthesia in patients undergoing gynecologic cancer surgery.
| Study group | Role | What they receive |
|---|---|---|
| obese patients undergoing low-flow anaesthesia | Low-flow anaesthesia was performed in patients with a body mass index between 30-40 Receives: Procedure: the effect of body mass index during low-flow anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative hospital stay
The primary aim of this study was to evaluate the duration of postoperative hospital stay
Measured: up to 10 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Nov 2024
- Primary completion1 Feb 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Gynecological Cancer 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Duygu Akyol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636448
- Sponsor's protocol ID
- 2024-04
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mychaskiw G 2nd. Low and minimal flow anesthesia: Angels dancing on the point of a needle. J Anaesthesiol Clin Pharmacol. 2012 Oct;28(4):423-5. doi: 10.4103/0970-9185.101883. No abstract available.
PubMed 23225917Oterkus M, Donmez I, Nadir AH, Rencuzogullari I, Karabag Y, Binnetoglu K. The effect of low flow anesthesia on hemodynamic and peripheral oxygenation parameters in obesity surgery. Saudi Med J. 2021 Mar;42(3):264-269. doi: 10.15537/smj.2021.42.3.20200575.
PubMed 33632904Akbas S, Ozkan AS. Comparison of effects of low-flow and normal-flow anesthesia on cerebral oxygenation and bispectral index in morbidly obese patients undergoing laparoscopic sleeve gastrectomy: a prospective, randomized clinical trial. Wideochir Inne Tech Maloinwazyjne. 2019 Jan;14(1):19-26. doi: 10.5114/wiitm.2018.77265. Epub 2018 Jul 24.
PubMed 30766625
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Mass Index on Patient Outcomes During Low-flow Anaesthesia for Major Gynaecological Cancer Surgery: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06636448
- Acronym / sponsor ID
- 2024-04
- Keywords
- major gynecological cancer surgery, low flow aneshesia, cerebral oxygenation, hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 10 Oct 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.
This study was designed as a prospective observational study.
Detailed description
In this study, it was planned to evaluate the effect of body mass index on patient outcomes during low flow anaesthesia in patients undergoing gynaecological cancer surgery on the specified dates. ASA II and III patients over 18 years of age were included in the study. Low flow anaesthesia is routinely applied in open gynaecological cancer surgeries in our clinic. The relationship between body mass index and intraoperative haemodynamic and mechanical ventilator values and postoperative patient outcomes will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obese patients undergoing low-flow anaesthesia | – | Procedure: the effect of body mass index during low-flow anesthesiaLow-flow anaesthesia was performed in patients with a body mass index between 30-40 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 40 patients were planned for this study
Key inclusion criteria (3 listed)
- Patients with ASA II-III
- \>18 years
- Patients undergoing major open surgery for endometrium, cervix or ovarian ca in gynaecological oncology clinic
Key exclusion criteria (4 listed)
- Patients who refused to participate in the study
- Cerebrovascular disease
- Those with severe pulmonary disease
- Those with serious cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the effect of body mass index during low-flow anesthesiaThe investigator planned to evaluate the effect of body mass index on patient outcomes during low-flow anesthesia in patients undergoing gynecologic cancer surgery. | Procedure or surgery | obese patients undergoing low-flow anaesthesia |
Primary outcome
postoperative hospital stay
Time frame: up to 10 days postoperative
The primary aim of this study was to evaluate the duration of postoperative hospital stay
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 13 Aug 2025.
- Background: PubMed 23225917Mychaskiw G 2nd. Low and minimal flow anesthesia: Angels dancing on the point of a needle. J Anaesthesiol Clin Pharmacol. 2012 Oct;28(4):423-5. doi: 10.4103/0970-9185.101883. No abstract available.
- Background: PubMed 33632904Oterkus M, Donmez I, Nadir AH, Rencuzogullari I, Karabag Y, Binnetoglu K. The effect of low flow anesthesia on hemodynamic and peripheral oxygenation parameters in obesity surgery. Saudi Med J. 2021 Mar;42(3):264-269. doi: 10.15537/smj.2021.42.3.20200575.
- Background: PubMed 30766625Akbas S, Ozkan AS. Comparison of effects of low-flow and normal-flow anesthesia on cerebral oxygenation and bispectral index in morbidly obese patients undergoing laparoscopic sleeve gastrectomy: a prospective, randomized clinical trial. Wideochir Inne Tech Maloinwazyjne. 2019 Jan;14(1):19-26. doi: 10.5114/wiitm.2018.77265. Epub 2018 Jul 24.
- Individual participant dataSharing planned: No
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 Major Gynecological Cancer Surgery and Low Flow Anesthesia, run by Bakirkoy Dr. Sadi Konuk Research and Training 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 3 inclusion and 4 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 13 Aug 2025. 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?
postoperative hospital stay (time frame: up to 10 days postoperative). 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 NCT06636448, which also lists 3 linked publications.
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 13 Aug 2025.