NCT06402474

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

May 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

1 month

First QC Date

May 1, 2024

Last Update Submit

May 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • inspiratory pressure

    effect on inspiratory pressure of two different position

    1 month

Study Arms (2)

sunbed position

30° reverse trendelenburg legs together 30° hip flexion (sunbed position)

Procedure: sunbed position

control

30° reverse trendelenburg

Procedure: sunbed position

Interventions

30° reverse trendelenburg legs together 30° hip flexion (sunbed position)

controlsunbed position

Eligibility Criteria

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

Patients aged 18-65 who underwent laparoscopic sleeve gastrectomy

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Patients with ASA class IV
  • patients with psychiatric disorders
  • pregnant or breastfeeding patients
  • patients with a history of seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 10926070BACKGROUND
  • Wang 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.

  • Shono 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.

  • Mulier 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.

  • Gao 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.

  • Seyit 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.

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. prof

Study Record Dates

First Submitted

May 1, 2024

First Posted

May 7, 2024

Study Start

May 1, 2024

Primary Completion

June 5, 2024

Study Completion

July 15, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05

Locations