Trendelenburg PositionNCT06685159
Predictors of Postoperative Complications in Surgery With Pneumoperitoneum in the Trendelenburg Position
An observational study of Trendelenburg Position and Pneumoperitoneum, run by Reuven Pizov at 1 site in Israel.
Trial summary
Evaluate early postoperative complications after surgery in Trendelenburg position with increased intraabdominal pressure (surgery with pneumoperitoneum). Evaluate the relationship between hemodynamic and metabolic changes on perioperative outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trendelenburg Position, Pneumoperitoneum
- What is being tested?
- Laparoscopic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Jun 2024to 19 Jun 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 who undergo elective laparoscopic surgery in the Hadassah Ein-Kerem Medical Center
Who may be able to join
- ASA Class I-IV.
- Planned for laparoscopic surgery in the Trendelenburg position that is expected to last more than 2 hours.
- Planned arterial catheter insertion.
Who cannot join
- Pregnancy.
- Planned open abdominal surgery.
- Renal Replacement Therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem, Yerushalaim
Adir Ben-Nahum, M.D., +972504677005, adirbn@gmail.com
About this study
Official title: Risk Factors for Postoperative Complications in Surgery With Pneumoperitoneum in Trendelenburg Position. Observational Pilot Study
Evaluate early postoperative complications after surgery in Trendelenburg position with increased intraabdominal pressure (surgery with pneumoperitoneum). Evaluate the relationship between hemodynamic and metabolic changes on perioperative outcome.
- Conditions
- Trendelenburg Position, Pneumoperitoneum
- Being tested
- Laparoscopic Surgery
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic SurgeryProcedure or surgery
Laparoscopic surgery (with controlled pneumoperitoneum) in the Trendelenburg position
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative change in urine NGAL
Measurement of the concentration of neutrophil gelatinase-associated lipocalin (as an early marker of kidney injury) in a urine sample taken from a Foley catheter
Measured: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Acute Kidney Injury
According to the KDIGO acute renal injury stage
Measured: 2 hours after completion of surgery; 1 day after the procedure; 3 days after the procedure.
Perioperative change in serum NGAL
Measurement of the concentration of neutrophil gelatinase-associated lipocalin (as an early marker of kidney injury) in a blood sample
Measured: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Perioperatitve change in serum concentration of Cannabidiol
Measurement of the concentration of cannabidiol (as an early marker of kidney injury) in a blood sample
Measured: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery and 2h hours after completion of surgery
Perioperatitve change in urine concentration of Cannabidiol
Measurement of the concentration of cannabidiol (as an early marker of kidney injury) in a urine sample taken from a Foley catheter
Measured: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Perioperatitve change in TBW
Perioperative change in the bioimpedence-based measurement of Total Body Water (TBW)
Measured: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Perioperatitve change in ECW
Perioperative change in the bioimpedence-based measurement of Extracellular Water (ECW)
Measured: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Perioperatitve change in serum pH
As measured by arterial blood gas
Measured: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Perioperatitve change in serum BE
Perioperatitve change in serum Base Excess (BE) As measured by arterial blood gas
Measured: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Perioperatitve change in serum lactate concentration
Perioperatitve change in serum lactate concentration as measured by arterial blood gas
Measured: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Perioperatitve change in serum syndecan-1 concentration
Measured by ELISA
Measured: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Secondary outcomes (7)
Delirium
As assessed by CAM-ICU
Measured: Within 7 days after surgery
CVA / TIA
New diagnosis of cerebrovascular accident or transient ischemic attack
Measured: Within 30 days after surgery
Myocardial Ischemia
New myocardial ischemia, as diagnosed by ecg or serum troponin
Measured: During hospital stay, within 30 days after surgery
Arrhythmia
New clinically significant arrhythmia
Measured: During hospital stay, within 30 days after surgery
Atelectasis
New atelectasis
Measured: During hospital stay, within 30 days after surgery
Pneumonia
According to CDC criteria
Measured: During hospital stay, within 30 days after surgery
ARDS
New Acute Respiratory Distress Syndrome (ARDS) according to Berlin criteria
Measured: During hospital stay, within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start19 Jun 2024
- Primary completion19 Jun 2026 (estimated)
- Study completion19 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trendelenburg PositionStudies 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
- Reuven Pizov
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reuven Pizov, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685159
- Sponsor's protocol ID
- 0303-23 HMO
- Status last verified
- Mar 2025
- First submitted
- 6 Nov 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Postoperative Complications in Surgery With Pneumoperitoneum in Trendelenburg Position. Observational Pilot Study
- ClinicalTrials.gov ID
- NCT06685159
- Acronym / sponsor ID
- 0303-23 HMO
- Conditions
- Trendelenburg Position, Pneumoperitoneum
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Reuven PizovUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 19 Jun 2026 (estimated)
- Study completion
- 19 Jun 2026 (estimated)
- First posted
- 12 Nov 2024 (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.
Evaluate early postoperative complications after surgery in Trendelenburg position with increased intraabdominal pressure (surgery with pneumoperitoneum). Evaluate the relationship between hemodynamic and metabolic changes on perioperative outcome.
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 who undergo elective laparoscopic surgery in the Hadassah Ein-Kerem Medical Center
Key inclusion criteria (3 listed)
- ASA Class I-IV.
- Planned for laparoscopic surgery in the Trendelenburg position that is expected to last more than 2 hours.
- Planned arterial catheter insertion.
Key exclusion criteria (3 listed)
- Pregnancy.
- Planned open abdominal surgery.
- Renal Replacement Therapy.
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 SurgeryLaparoscopic surgery (with controlled pneumoperitoneum) in the Trendelenburg position | Procedure or surgery | – |
Primary outcome
Perioperative change in urine NGAL
Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Measurement of the concentration of neutrophil gelatinase-associated lipocalin (as an early marker of kidney injury) in a urine sample taken from a Foley catheter
Acute Kidney Injury
Time frame: 2 hours after completion of surgery; 1 day after the procedure; 3 days after the procedure.
According to the KDIGO acute renal injury stage
Perioperative change in serum NGAL
Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Measurement of the concentration of neutrophil gelatinase-associated lipocalin (as an early marker of kidney injury) in a blood sample
Perioperatitve change in serum concentration of Cannabidiol
Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery and 2h hours after completion of surgery
Measurement of the concentration of cannabidiol (as an early marker of kidney injury) in a blood sample
Perioperatitve change in urine concentration of Cannabidiol
Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Measurement of the concentration of cannabidiol (as an early marker of kidney injury) in a urine sample taken from a Foley catheter
Perioperatitve change in TBW
Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Perioperative change in the bioimpedence-based measurement of Total Body Water (TBW)
Perioperatitve change in ECW
Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Perioperative change in the bioimpedence-based measurement of Extracellular Water (ECW)
Perioperatitve change in serum pH
Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
As measured by arterial blood gas
Perioperatitve change in serum BE
Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Perioperatitve change in serum Base Excess (BE) As measured by arterial blood gas
Perioperatitve change in serum lactate concentration
Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Perioperatitve change in serum lactate concentration as measured by arterial blood gas
Perioperatitve change in serum syndecan-1 concentration
Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Measured by ELISA
7 secondary outcomes
Delirium
Time frame: Within 7 days after surgery
CVA / TIA
Time frame: Within 30 days after surgery
Myocardial Ischemia
Time frame: During hospital stay, within 30 days after surgery
Arrhythmia
Time frame: During hospital stay, within 30 days after surgery
Atelectasis
Time frame: During hospital stay, within 30 days after surgery
Pneumonia
Time frame: During hospital stay, within 30 days after surgery
ARDS
Time frame: During hospital stay, within 30 days after surgery
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 1 Apr 2025.
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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 Trendelenburg Position and Pneumoperitoneum, run by Reuven Pizov at 1 site in Israel.
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 3 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 1 Apr 2025. 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 Israel. 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 Reuven Pizov, MD (+9720506265542, pizovr@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative change in urine NGAL (time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery). The study lists 11 primary outcomes in all. 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 1 Apr 2025.