Effect of Two Different Surgical Positions on Pulmonary Functions in Laparoscopic Gastrectomies

May 3, 2024 updated by: İlke Dolgun, Istinye University
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez Mahallesi
      • Istanbul, Merkez Mahallesi, Turkey, 34250
        • Istinye University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18-65 who underwent laparoscopic sleeve gastrectomy

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
sunbed position
30° reverse trendelenburg legs together 30° hip flexion (sunbed position)
Procedure: sunbed position
30° reverse trendelenburg legs together 30° hip flexion (sunbed position)
control
30° reverse trendelenburg
Procedure: sunbed position
30° reverse trendelenburg legs together 30° hip flexion (sunbed position)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inspiratory pressure
Time Frame: 1 month
effect on inspiratory pressure of two different position
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istinye University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

June 5, 2024

Study Completion (Estimated)

July 15, 2024

Study Registration Dates

First Submitted

May 1, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • istinye ilke

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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