Clinical trial · Interventional
Impacts of Different Pressure Pneumoperitoneum on Myocardial and Pulmonary Injuries After Robot-assisted Surgery
Comparison of the Impacts of Prolonged Low-pressure and Standard-pressure Pneumoperitoneum on Myocardial and Pulmonary Injuries After Robot-assisted Surgery in the Trendelenburg Position: a Bi-center, Randomized Controlled Trial
NCT02600481CI-TRIAL-00019747unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is aimed to determine whether low- and standard-pressure pneumoperitoneum have different impacts on troponin T（TnT) level as well as pulmonary complications after prolonged robot-assisted surgeries in the Trendelenburg position.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low-pressure pneumoperitoneum | Procedure | — | UNRESOLVED |
| standard-pressure pneumoperitoneum | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- low-pressure pneumoperitoneum group
- description
- Subjects assigned to the low-pressure pneumoperitoneum group will receive 7-10 mm Hg carbon dioxide pneumoperitoneum, and the expected duration is longer than 3 hours to complete robot-assisted surgeries in the Trendelenburg position;
- interventionNames
- Procedure: low-pressure pneumoperitoneum
- type
- ACTIVE_COMPARATOR
- label
- standard-pressure pneumoperitoneum group
- description
- Subjects assigned to the standard-pressure pneumoperitoneum group will receive 12-16 mm Hg carbon dioxide pneumoperitoneum, which is expected lasted longer than 3 hours to complete robot-assisted surgeries in the Trendelenburg position;
- interventionNames
- Procedure: standard-pressure pneumoperitoneum
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are scheduled to undergo Robot-assisted radical prostatectomy or other robot-assisted urological surgeries last longer than 3 hours * Patients who are classified as American Society of Anesthesiologists（ASA）I and II * Patient's preoperative troponin T(TnT) level is normal Exclusion Criteria: * Patients with preoperative cardiopulmonary dysfunction who can not understand prolonged surgeries in the Trendelenburg position：severe pulmonary dysfunction or New York Heart Association(NYHA) classification is Ⅲ-Ⅳ. * Body Mass Index\>30. * Any intraoperative situation as follows：1. Any cause to cancel operation or change robot-assisted surgery to open surgery 2. Intraoperative cardiovascular accidents.
References
Publications (28)
- BACKGROUNDFinkelstein J, Eckersberger E, Sadri H, Taneja SS, Lepor H, Djavan B. Open Versus Laparoscopic Versus Robot-Assisted Laparoscopic Prostatectomy: The European and US Experience. Rev Urol. 2010 Winter;12(1):35-43. PMID 20428292
- BACKGROUNDOrvieto MA, Patel VR. Evolution of robot-assisted radical prostatectomy. Scand J Surg. 2009;98(2):76-88. doi: 10.1177/145749690909800203. PMID 19799045
- BACKGROUNDHakimi AA, Feder M, Ghavamian R. Minimally invasive approaches to prostate cancer: a review of the current literature. Urol J. 2007 Summer;4(3):130-7. PMID 17987573
- BACKGROUNDMeininger D, Byhahn C, Bueck M, Binder J, Kramer W, Kessler P, Westphal K. Effects of prolonged pneumoperitoneum on hemodynamics and acid-base balance during totally endoscopic robot-assisted radical prostatectomies. World J Surg. 2002 Dec;26(12):1423-7. doi: 10.1007/s00268-002-6404-7. Epub 2002 Sep 26. PMID 12297911
- BACKGROUNDYiannakopoulou ECh, Nikiteas N, Perrea D, Tsigris C. Effect of laparoscopic surgery on oxidative stress response: systematic review. Surg Laparosc Endosc Percutan Tech. 2013 Apr;23(2):101-8. doi: 10.1097/SLE.0b013e3182827b33. PMID 23579502
- BACKGROUNDSharma KC, Kabinoff G, Ducheine Y, Tierney J, Brandstetter RD. Laparoscopic surgery and its potential for medical complications. Heart Lung. 1997 Jan-Feb;26(1):52-64; quiz 65-7. doi: 10.1016/s0147-9563(97)90009-1. PMID 9013221
- BACKGROUNDLeduc LJ, Mitchell A. Intestinal ischemia after laparoscopic cholecystectomy. JSLS. 2006 Apr-Jun;10(2):236-8. PMID 16882427
- BACKGROUNDde Cleva R, Silva FP, Zilberstein B, Machado DJ. Acute renal failure due to abdominal compartment syndrome: report on four cases and literature review. Rev Hosp Clin Fac Med Sao Paulo. 2001 Jul-Aug;56(4):123-30. doi: 10.1590/s0041-87812001000400006.