Hernia, InguinalTAPPHCO3NCT07473583
Pneumoperitoneum Duration and Bicarbonate Changes in Laparoscopic Hernia Surgery
An observational study of Hernia, Inguinal and Inguinal Hernia, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Inguinal, Inguinal Hernia
- What is being tested?
- Laparoscopic Inguinal Hernia Repair (TAPP)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2026to 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 laparoscopic inguinal hernia repair (TAPP) at Haseki Training and Research Hospital will be included. Perioperative pneumoperitoneum duration and serum bicarbonate changes will be analyzed using blood gas measurements obtained preoperatively and at the second postoperative hour.
Who may be able to join
- Age ≥18 years
- Patients undergoing laparoscopic inguinal hernia repair using the TAPP technique
- Ability to provide informed consent
Who cannot join
- Pregnancy
- Severe cardiovascular disease
- Renal insufficiency
- Patients requiring additional intra-abdominal surgical procedures
- Strangulated inguinal hernia requiring bowel resection
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, 1 recruiting
- Recruiting
Haseki Training and Research Hospital
Istanbul, 34265
Muzaffer Akinci, MD, +90 532 431 3613, muzoakinci@hotmail.com
Bahar Canbay Torun, MD, +90 505 389 0489, baharcanbay@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Hernia, Inguinal, Inguinal Hernia
- Being tested
- Laparoscopic Inguinal Hernia Repair (TAPP)
- Keywords
- Pneumoperitoneum, Laparoscopic Inguinal Hernia Repair, Serum Bicarbonate, Blood Gas Analysis, TAPP Technique
- Medical subject headings
- Hernia, Inguinal, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Inguinal Hernia Repair (TAPP)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Laparoscopic Inguinal Hernia Repair (TAPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Bicarbonate Level
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
Measured: Preoperative to postoperative 2 hours
Secondary outcomes (4)
Postoperative Pain Score
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)
Measured: Within 24 hours after surgery
Change in Arterial Blood pH
Change in arterial blood pH measured during pneumoperitoneum.
Unit of Measure: pH
Measured: Preoperative to postoperative 2 hours
Early Postoperative Complications
Early postoperative complications occurring within the first 24 hours after laparoscopic inguinal hernia repair.
Measured: Within 24 hours
Change in Arterial Partial Pressure of Carbon Dioxide
Change in arterial PaCO₂ levels measured intraoperatively.
Unit of Measure: mmHg
Measured: Preoperative to postoperative 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start10 Mar 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muzaffer Akinci, MD, Principal investigator, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473583
- Sponsor's protocol ID
- HASEKI-305-2025
- Acronym
- TAPPHCO3
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional data protection policies and patient confidentiality requirements. Only aggregated and anonymized data will be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Pneumoperitoneum Duration and Changes in Serum Bicarbonate Levels in Patients Undergoing Laparoscopic Inguinal Hernia Repair: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07473583
- Acronym / sponsor ID
- TAPPHCO3 / HASEKI-305-2025
- Conditions
- Hernia, Inguinal, Inguinal Hernia
- Keywords
- Pneumoperitoneum, Laparoscopic Inguinal Hernia Repair, Serum Bicarbonate, Blood Gas Analysis, TAPP Technique
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 16 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Inguinal Hernia Patients | – | Procedure: Laparoscopic Inguinal Hernia Repair (TAPP)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing laparoscopic inguinal hernia repair (TAPP) at Haseki Training and Research Hospital will be included. Perioperative pneumoperitoneum duration and serum bicarbonate changes will be analyzed using blood gas measurements obtained preoperatively and at the second postoperative hour.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Patients undergoing laparoscopic inguinal hernia repair using the TAPP technique
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- Pregnancy
- Severe cardiovascular disease
- Renal insufficiency
- Patients requiring additional intra-abdominal surgical procedures
- Strangulated inguinal hernia requiring bowel resection
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 Inguinal Hernia Repair (TAPP)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. | Procedure or surgery | Laparoscopic Inguinal Hernia Patients |
Primary outcome
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
4 secondary outcomes
Postoperative Pain Score
Time frame: Within 24 hours after surgery
Change in Arterial Blood pH
Time frame: Preoperative to postoperative 2 hours
Early Postoperative Complications
Time frame: Within 24 hours
Change in Arterial Partial Pressure of Carbon Dioxide
Time frame: Preoperative to postoperative 2 hours
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 16 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional data protection policies and patient confidentiality requirements. Only aggregated and anonymized data will be reported in scientific publications.
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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.
Muzaffer Akinci, MD principal investigator
Haseki Training and Research Hospital
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 Hernia, Inguinal and Inguinal Hernia, run by Haseki Training and Research Hospital 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 16 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 Osman Sibic, MD (+90 534 617 72 53, osmansibic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Bicarbonate Level (time frame: Preoperative to postoperative 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2026.