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Not yet recruiting NCT07445230

Serum Bicarbonate Changes During Laparoscopic Bariatric Surgery

Observational Acid Base Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laparoscopic Bariatric Surgery.
Who it may be relevant to
Registry conditions: Acid Base Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Metabolic Effects of Pneumoperitoneum During Laparoscopic Bariatric Surgery: Association Between Perioperative Serum Bicarbonate Change and Early Discharge Readiness

Overview

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.

Interventions

  • Other Laparoscopic Bariatric Surgery
    Standard-of-care laparoscopic bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass) performed according to institutional protocols. No experimental intervention is introduced. The study prospectively observes perioperative serum bicarbonate changes and their association with pneumoperitoneum duration and early discharge readiness.

Primary outcome measures

  • Perioperative Serum Bicarbonate Change (ΔHCO₃-) [Time frame: From baseline (after induction, before pneumoperitoneum) to 24 hours postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Istinye Üniversity — Istanbul

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. PMID 39028346
  • 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. PMID 31699651

Identifiers

NCT: NCT07445230 · NaHCO3 and bariatrics

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗