The Effect of Intrabdominal Pressure in Patients Undergoing Bariatric Surgery

NCT04929639 | Completed

• 1 other identifier: 09.2020.133
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Morbid obesity is a global health problem that concerns the whole world. It is associated with many concomitant health problems such as diabetes, hypertension, congestive heart failure. There are publications showing that morbid obesity increases chronic intra-abdominal pressure, and it has been investigated that this chronic pressure exposure may cause many comorbidities accompanying obesity. When we reviewed the literature, we could not find an adequate study showing the effects of obesity-related increased intra-abdominal pressure on postoperative mortality and morbidity. The aim of this study is to show the effect of obesity-related intra-abdominal pressure on postoperative mortality and morbidity.

Conditions

Intraabdominal Pressure; Bariatrik Surgery

Outcome Measures

Primary Outcomes (1)

• the effect of obesity-related intra-abdominal pressure

  measure intra-abdominal pressure from the trochar site

  during procedure

Interventions

measurment of intraabdominal surgery OTHER

Immediately after intubation, while the patient is lying in the supine position, an intra-abdominal measurement will be made from the bladder catheter and recorded. Then, after the surgical site antisepsis, when the trocar required for the operation is placed by the general surgeon, another measurement will be made from the trocar port. Measurements will be recorded.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: female patient
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

ASA (American Society of Anesthesia) II-III female patient who is planned to undergo laparoscopic sleeve gasterctomy or bypass operation will be included. BMI (body Mass Index)\> 35, 18-60 years old, female, non-smoker

You may qualify if:

• ASA (American Society of Anesthesia) II-III female patient who is planned to undergo laparoscopic sleeve gasterctomy or bypass operation will be included. BMI (body Mass Index)\> 35, 18-60 years old, female, non-smoker, not undergoing revisional bariatric surgery, and not undergoing major abdominal surgery before were included

You may not qualify if:

• Patients with severe cardiac and respiratory distress, liver and kidney failure, and those who did not consent to the study will not be accepted into the study.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

Study Officials

• MELIHA ORHON ERGUN

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 18, 2021
• Study Start: January 5, 2020
• Primary Completion: June 5, 2020
• Study Completion: May 5, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

TU (1)