NCT07445230

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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

February 25, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 25, 2026

Last Update Submit

February 25, 2026

Conditions

Acid Base Disorder

Outcome Measures

Primary Outcomes (1)

  • Perioperative Serum Bicarbonate Change (ΔHCO₃-)

    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

Interventions

Laparoscopic Bariatric SurgeryOTHER

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.

Eligibility Criteria

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

Adult patients undergoing elective laparoscopic bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass) at a single tertiary care center. Participants will be enrolled consecutively and followed prospectively to assess perioperative serum bicarbonate changes and early discharge readiness without altering routine clinical management.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (2)

  • 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: 39028346RESULT

  • 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: 31699651RESULT

Central Study Contacts

ilke dolgun

CONTACT

+905555485632ilkeser2004@gmail.com

Study Design

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

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 3, 2026

Study Start

March 1, 2026

Primary Completion

April 30, 2026

Study Completion

May 15, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations

TU(1)