Acid Base DisorderNCT07445230
Serum Bicarbonate Changes During Laparoscopic Bariatric Surgery
An observational study of Acid Base Disorder, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acid Base Disorder
- What is being tested?
- Laparoscopic Bariatric Surgery
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 15 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
About this study
Official title: 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.
- Conditions
- Acid Base Disorder
- Being tested
- Laparoscopic Bariatric Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (after induction, before pneumoperitoneum) to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acid Base DisorderStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445230
- Sponsor's protocol ID
- NaHCO3 and bariatrics
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 39028346Aftab 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.
PubMed 31699651
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Pneumoperitoneum During Laparoscopic Bariatric Surgery: Association Between Perioperative Serum Bicarbonate Change and Early Discharge Readiness
- ClinicalTrials.gov ID
- NCT07445230
- Acronym / sponsor ID
- NaHCO3 and bariatrics
- Conditions
- Acid Base Disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Bariatric SurgeryStandard-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. | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Results publication: PubMed 39028346Cooper 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.
- Results publication: PubMed 31699651Aftab 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acid Base Disorder, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ilke dolgun (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Serum Bicarbonate Change (ΔHCO₃-) (time frame: From baseline (after induction, before pneumoperitoneum) to 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07445230, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.