Pulmonary PathologyNCT06402474
Effect of Two Different Surgical Positions on Pulmonary Functions in Laparoscopic Gastrectomies
An observational study of Pulmonary Pathology, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
The primary purpose of the study is to investigate the effect of the 30° reverse trendelenburg position combined with the sunbed position on respiratory parameters in laparoscopic gastrectomies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Pathology
- What is being tested?
- sunbed position
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 15 Jul 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-65 who underwent laparoscopic sleeve gastrectomy
Who may be able to join
- Patients who can tolerate general anesthesia and pneumoperitoneum.
- Patients who can give informed consent for surgery.
- Patients over 18 years of age
- patients with body mass index (BMI) > 30 kg/m2
- Patients with American Society of Anesthesiologists (ASA) physical status I and II
Who cannot join
- Patients with serious underlying cardiovascular disease (e.g. congestive heart failure, conduction disorders and ischemic heart disease).
- Patients with chronic kidney disease stage 3 or greater (creatinine clearance less than 60 mL/min).
- patients with a history of cerebrovascular disease such as intracranial hypertension, cerebral infarction, cerebral hemorrhage, carotid artery stenosis or cerebral ischemia;
- Patients with a history of chronic lung diseases such as chronic obstructive pulmonary disease, asthma, pulmonary bullae or respiratory failure;
- Patients who have had previous abdominal surgery, including resection of the esophagus, stomach, liver and pancreas.
- Surgeries lasting longer than 90 minutes
Show all 10Show fewer
- Patients with ASA class IV
- patients with psychiatric disorders
- pregnant or breastfeeding patients
- patients with a history of seizures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
About this study
The primary purpose of the study is to investigate the effect of the 30° reverse trendelenburg position combined with the sunbed position on respiratory parameters in laparoscopic gastrectomies.
- Conditions
- Pulmonary Pathology
- Being tested
- sunbed position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunbed positionProcedure or surgery
30° reverse trendelenburg legs together 30° hip flexion (sunbed position)
| Study group | Role | What they receive |
|---|---|---|
| sunbed position | 30° reverse trendelenburg legs together 30° hip flexion (sunbed position) Receives: Procedure: sunbed position | |
| control | 30° reverse trendelenburg Receives: Procedure: sunbed position |
What is being measured
The primary outcome is the main question the study is designed to answer.
inspiratory pressure
effect on inspiratory pressure of two different position
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 May 2024
- Primary completion5 Jun 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary PathologyStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402474
- Sponsor's protocol ID
- istinye ilke
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Casati A, Comotti L, Tommasino C, Leggieri C, Bignami E, Tarantino F, Torri G. Effects of pneumoperitoneum and reverse Trendelenburg position on cardiopulmonary function in morbidly obese patients receiving laparoscopic gastric banding. Eur J Anaesthesiol. 2000 May;17(5):300-5. doi: 10.1046/j.1365-2346.2000.00662.x.
PubMed 10926070Wang Y, Wang H, Wang H, Zhao X, Li S, Chen L. Exploring the intraoperative lung protective ventilation of different positive end-expiratory pressure levels during abdominal laparoscopic surgery with Trendelenburg position. Ann Transl Med. 2019 Apr;7(8):171. doi: 10.21037/atm.2019.03.45.
PubMed 31168452Shono A, Katayama N, Fujihara T, Bohm SH, Waldmann AD, Ugata K, Nikai T, Saito Y. Positive End-expiratory Pressure and Distribution of Ventilation in Pneumoperitoneum Combined with Steep Trendelenburg Position. Anesthesiology. 2020 Mar;132(3):476-490. doi: 10.1097/ALN.0000000000003062.
PubMed 31770148Mulier JP, Dillemans B, Van Cauwenberge S. Impact of the patient's body position on the intraabdominal workspace during laparoscopic surgery. Surg Endosc. 2010 Jun;24(6):1398-402. doi: 10.1007/s00464-009-0785-8. Epub 2010 Jan 7.
PubMed 20054583Gao D, Sun L, Wang N, Shi Y, Song J, Liu X, Yang Q, Su Z. Impact of 30 degrees Reserve Trendelenburg Position on Lung Function in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy. Front Surg. 2022 Feb 24;9:792697. doi: 10.3389/fsurg.2022.792697. eCollection 2022.
PubMed 35284476Seyit H, Dolgun I, Bayram E, Sener FN, Cicek M. The effect of two different surgical positions on pulmonary functions in laparoscopic sleeve gastrectomies: reverse Trendelenburg vs beach chair. Surg Endosc. 2025 Mar;39(3):1829-1838. doi: 10.1007/s00464-025-11538-2. Epub 2025 Jan 21.
PubMed 39838149
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Surgical Positions on Pulmonary Functions in Laparoscopic Gastrectomies
- ClinicalTrials.gov ID
- NCT06402474
- Acronym / sponsor ID
- istinye ilke
- Conditions
- Pulmonary Pathology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 5 Jun 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 7 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.
The primary purpose of the study is to investigate the effect of the 30° reverse trendelenburg position combined with the sunbed position on respiratory parameters in laparoscopic gastrectomies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sunbed position | – | Procedure: sunbed position30° reverse trendelenburg legs together 30° hip flexion (sunbed position) |
| control | – | Procedure: sunbed position30° reverse trendelenburg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-65 who underwent laparoscopic sleeve gastrectomy
Key inclusion criteria (5 listed)
- Patients who can tolerate general anesthesia and pneumoperitoneum.
- Patients who can give informed consent for surgery.
- Patients over 18 years of age
- patients with body mass index (BMI) > 30 kg/m2
- Patients with American Society of Anesthesiologists (ASA) physical status I and II
Key exclusion criteria (10 listed)
- Patients with serious underlying cardiovascular disease (e.g. congestive heart failure, conduction disorders and ischemic heart disease).
- Patients with chronic kidney disease stage 3 or greater (creatinine clearance less than 60 mL/min).
- patients with a history of cerebrovascular disease such as intracranial hypertension, cerebral infarction, cerebral hemorrhage, carotid artery stenosis or cerebral ischemia;
- Patients with a history of chronic lung diseases such as chronic obstructive pulmonary disease, asthma, pulmonary bullae or respiratory failure;
- Patients who have had previous abdominal surgery, including resection of the esophagus, stomach, liver and pancreas.
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 |
|---|---|---|
| sunbed position30° reverse trendelenburg legs together 30° hip flexion (sunbed position) | Procedure or surgery | control, sunbed position |
Primary outcome
inspiratory pressure
Time frame: 1 month
effect on inspiratory pressure of two different position
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Background: PubMed 10926070Casati A, Comotti L, Tommasino C, Leggieri C, Bignami E, Tarantino F, Torri G. Effects of pneumoperitoneum and reverse Trendelenburg position on cardiopulmonary function in morbidly obese patients receiving laparoscopic gastric banding. Eur J Anaesthesiol. 2000 May;17(5):300-5. doi: 10.1046/j.1365-2346.2000.00662.x.
- Results publication: PubMed 31168452Wang Y, Wang H, Wang H, Zhao X, Li S, Chen L. Exploring the intraoperative lung protective ventilation of different positive end-expiratory pressure levels during abdominal laparoscopic surgery with Trendelenburg position. Ann Transl Med. 2019 Apr;7(8):171. doi: 10.21037/atm.2019.03.45.
- Results publication: PubMed 31770148Shono A, Katayama N, Fujihara T, Bohm SH, Waldmann AD, Ugata K, Nikai T, Saito Y. Positive End-expiratory Pressure and Distribution of Ventilation in Pneumoperitoneum Combined with Steep Trendelenburg Position. Anesthesiology. 2020 Mar;132(3):476-490. doi: 10.1097/ALN.0000000000003062.
- Results publication: PubMed 20054583Mulier JP, Dillemans B, Van Cauwenberge S. Impact of the patient's body position on the intraabdominal workspace during laparoscopic surgery. Surg Endosc. 2010 Jun;24(6):1398-402. doi: 10.1007/s00464-009-0785-8. Epub 2010 Jan 7.
- Results publication: PubMed 35284476Gao D, Sun L, Wang N, Shi Y, Song J, Liu X, Yang Q, Su Z. Impact of 30 degrees Reserve Trendelenburg Position on Lung Function in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy. Front Surg. 2022 Feb 24;9:792697. doi: 10.3389/fsurg.2022.792697. eCollection 2022.
- Derived from this study: PubMed 39838149Seyit H, Dolgun I, Bayram E, Sener FN, Cicek M. The effect of two different surgical positions on pulmonary functions in laparoscopic sleeve gastrectomies: reverse Trendelenburg vs beach chair. Surg Endosc. 2025 Mar;39(3):1829-1838. doi: 10.1007/s00464-025-11538-2. Epub 2025 Jan 21.
- 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 Pulmonary Pathology, run by Istinye University 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 7 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?
Results are not available in the source record.
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?
inspiratory pressure (time frame: 1 month). 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 NCT06402474, which also lists 6 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 7 May 2024.