- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445230
Serum Bicarbonate Changes During Laparoscopic Bariatric Surgery
Metabolic Effects of Pneumoperitoneum During Laparoscopic Bariatric Surgery: Association Between Perioperative Serum Bicarbonate Change and Early Discharge Readiness
Pneumoperitoneum during laparoscopic bariatric surgery induces carbon dioxide absorption and may lead to perioperative alterations in acid-base balance. Serum bicarbonate (HCO₃-) plays a central role in metabolic compensation; however, the clinical relevance of perioperative bicarbonate changes remains insufficiently defined.
This prospective observational study aims to evaluate the association between pneumoperitoneum duration and perioperative serum bicarbonate change (ΔHCO₃-), and to investigate whether ΔHCO₃- is associated with early discharge readiness at 48 hours (DR-48) following laparoscopic bariatric surgery. Patients undergoing laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass will be enrolled consecutively. No alteration of routine clinical care will occur.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: ilke dolgun
- Phone Number: +905555485632
- Email: ilkeser2004@gmail.com
Study Locations
-
-
Merkez Mahallesi
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Istanbul, Merkez Mahallesi, Turkey (Türkiye), 34250
- Istinye University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged ≥18 years
- ASA physical status I-III
- Scheduled for elective laparoscopic bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass)
- Provided written informed consent
Exclusion Criteria:
- Age <18 years
- ASA physical status IV or higher
- Chronic obstructive pulmonary disease (COPD), asthma, or other severe chronic respiratory disease
- Known chronic metabolic acidosis or renal failure
- Major intraoperative complications (e.g., severe bleeding, conversion to open surgery)
- Postoperative reoperation, intensive care requirement, or complications preventing standard recovery evaluation
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perioperative Serum Bicarbonate Change (ΔHCO₃-)
Time Frame: From baseline (after induction, before pneumoperitoneum) to 24 hours postoperatively
|
Change in serum bicarbonate (HCO₃-) between the preoperative value (after induction, before pneumoperitoneum) and the postoperative 24-hour value, calculated as: ΔHCO₃- = HCO₃-(24 h postoperative) - HCO₃-(preoperative). The association between pneumoperitoneum duration (minutes) and ΔHCO₃- will be evaluated. |
From baseline (after induction, before pneumoperitoneum) to 24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Cooper S, Patel S, Wynn M, Provost D, Hassan M. Outcomes of same-day discharge in bariatric surgery. Surg Endosc. 2024 Sep;38(9):5122-5129. doi: 10.1007/s00464-024-11053-w. Epub 2024 Jul 19.
- Aftab H, Fagerland MW, Gondal G, Ghanima W, Olsen MK, Nordby T. Gastric sleeve resection as day-case surgery: what affects the discharge time? Surg Obes Relat Dis. 2019 Dec;15(12):2018-2024. doi: 10.1016/j.soard.2019.09.070. Epub 2019 Sep 23.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NaHCO3 and bariatrics
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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