- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07473583
Pneumoperitoneum Duration and Bicarbonate Changes in Laparoscopic Hernia Surgery (TAPPHCO3)
Association Between Pneumoperitoneum Duration and Changes in Serum Bicarbonate Levels in Patients Undergoing Laparoscopic Inguinal Hernia Repair: A Prospective Observational Study
The goal of this observational study is to learn how the length of pneumoperitoneum during laparoscopic inguinal hernia surgery may affect changes in blood bicarbonate levels. Pneumoperitoneum is the use of carbon dioxide gas to create space inside the abdomen during laparoscopic surgery.
The main question this study aims to answer is whether a longer pneumoperitoneum time is associated with changes in blood bicarbonate levels after surgery.
Participants are adults undergoing laparoscopic inguinal hernia repair as part of their routine medical care. Researchers will measure blood gas values, including bicarbonate levels, before surgery and again two hours after surgery. The change in bicarbonate levels will be compared with the duration of pneumoperitoneum during the operation.
The results of this study may help improve the understanding of metabolic changes that occur during laparoscopic surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Carbon dioxide pneumoperitoneum is routinely used during laparoscopic surgery to provide adequate visualization and working space. However, absorption of carbon dioxide and increased intra-abdominal pressure may influence acid-base balance during the perioperative period. These physiological changes may be reflected in blood gas parameters such as pH, partial pressure of carbon dioxide (pCO2), and serum bicarbonate levels.
This prospective observational study aims to evaluate the relationship between pneumoperitoneum duration and perioperative changes in serum bicarbonate levels in patients undergoing laparoscopic inguinal hernia repair using the transabdominal preperitoneal (TAPP) technique.
Adult patients undergoing elective laparoscopic inguinal hernia repair will be included in the study. Blood gas measurements will be obtained before surgery and at the second postoperative hour. Serum bicarbonate levels will be recorded, and the difference between preoperative and postoperative measurements (ΔHCO3-) will be calculated.
The primary outcome of the study is the change in serum bicarbonate levels between the preoperative and postoperative second-hour measurements. Secondary outcomes include postoperative pain scores, postoperative acid-base parameters such as pH and pCO2, and early postoperative complications within the first 24 hours.
Pneumoperitoneum duration will be recorded intraoperatively and analyzed for its association with perioperative metabolic changes. The findings of this study may contribute to a better understanding of metabolic alterations occurring during laparoscopic surgery and their potential clinical implications.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Osman Sibic, MD
- Phone Number: +90 534 617 72 53
- Email: osmansibic@gmail.com
Study Contact Backup
- Name: Bahar Canbay Torun, MD
- Phone Number: +90 505 389 0489
- Email: baharcanbay@gmail.com
Study Locations
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Istanbul, Turkey (Türkiye), 34265
- Recruiting
- Haseki Training and Research Hospital
-
Contact:
- Bahar Canbay Torun, MD
- Phone Number: +90 505 389 0489
- Email: baharcanbay@gmail.com
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Contact:
- Muzaffer Akinci, MD
- Phone Number: +90 532 431 3613
- Email: muzoakinci@hotmail.com
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Principal Investigator:
- Muzaffer Akinci, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years
- Patients undergoing laparoscopic inguinal hernia repair using the TAPP technique
- Ability to provide informed consent
Exclusion Criteria:
- Pregnancy
- Severe cardiovascular disease
- Renal insufficiency
- Patients requiring additional intra-abdominal surgical procedures
- Strangulated inguinal hernia requiring bowel resection
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Laparoscopic Inguinal Hernia Patients
Adult patients undergoing laparoscopic inguinal hernia repair (TAPP).
Pneumoperitoneum duration and perioperative serum bicarbonate changes will be analyzed using blood gas measurements obtained preoperatively and at the second postoperative hour.
|
Standard laparoscopic inguinal hernia repair performed using the transabdominal preperitoneal (TAPP) technique as part of routine clinical care.
Pneumoperitoneum duration during the procedure will be recorded for analysis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Serum Bicarbonate Level
Time Frame: Preoperative to postoperative 2 hours
|
Difference between preoperative and postoperative second-hour serum bicarbonate levels measured by blood gas analysis in patients undergoing laparoscopic inguinal hernia repair. Unit of Measure: mmol/L |
Preoperative to postoperative 2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Score
Time Frame: Within 24 hours after surgery
|
Postoperative pain intensity measured using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain severity. Unit of Measure: VAS score (0-10) |
Within 24 hours after surgery
|
|
Change in Arterial Blood pH
Time Frame: Preoperative to postoperative 2 hours
|
Change in arterial blood pH measured during pneumoperitoneum. Unit of Measure: pH |
Preoperative to postoperative 2 hours
|
|
Early Postoperative Complications
Time Frame: Within 24 hours
|
Early postoperative complications occurring within the first 24 hours after laparoscopic inguinal hernia repair.
|
Within 24 hours
|
|
Change in Arterial Partial Pressure of Carbon Dioxide
Time Frame: Preoperative to postoperative 2 hours
|
Change in arterial PaCO₂ levels measured intraoperatively. Unit of Measure: mmHg |
Preoperative to postoperative 2 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Muzaffer Akinci, MD, Haseki Training and Research Hospital
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HASEKI-305-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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