Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The hypothesis of this study is based on several studies reported that increased postoperative troponin T(TnT) level was significantly associated with 30-day mortality, and some other reports showed that low-pressure pneumoperitoneum had better haemodynamic outcome than that of standard-pressure pneumoperitoneum. Hence, we hypothesize that different pneumoperitoneal pressure may lead to different levels of TnT after prolonged robot-assisted surgeries.
This clinical trial will be conducted in Huadong Hospital Affiliated to Fudan University and Ruijin Hospital Shanghai Jiao Tong University School of Medicine,both are tertiary hospitals in Shanghai, China.
After signing the Informed Consent, subjects who meet the eligibility criteria will be randomly assigned to low- or standard-pressure pneumoperitoneum group.The randomization plans will be implemented using statistical software R, and will be stored in an online database.These subjects will be recruited from January 1st 2016 to December 31st 2017.
TnT is set as the primary endpoint for this trial to evaluate the myocardial injuries, and will be measured for each patient who will undergo in-patient robot-assisted urological surgery within 24 hours postoperatively using the fourth-generation high-sensitivity TnT assay.
The total sample size will be 280.With 140 patients in each of the two treatment groups, the power will be at least 0.70 to detect an increment of TnT level among 80% of subjects.Chest CT scan is used to diagnose the pulmonary complications on the third day postoperatively.
Data will be collected to analysize whether prolonged different intraperitoneal pressure has different impacts on cardiopulmonary injuries.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-pressure pneumoperitoneum group | Experimental | 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; |
|
| standard-pressure pneumoperitoneum group | Active Comparator | 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; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-pressure pneumoperitoneum | Procedure | Using low-pressure(between 7-10 mm Hg ) pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Troponin T level is set as the marker of myocardial injuries after robot-assisted surgeries | Within the first 24 hours after prolonged robot-assisted surgeries |
| Measure | Description | Time Frame |
|---|---|---|
| Chest CT scan is used to determine pulmonary complications | On the third day after prolonged robot-assisted surgeries |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weidong Gu, Doctor | Contact | +86-21-62483180 | 70603 | mcwgwd@163.com |
| Xixue Zhang, Master | Contact | +86-21-62483180 | 70603 | zxxdoc@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weidong Gu, Doctor | Huadong Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20428292 | Background | Finkelstein 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. | |
| 19799045 | Background | Orvieto MA, Patel VR. Evolution of robot-assisted radical prostatectomy. Scand J Surg. 2009;98(2):76-88. doi: 10.1177/145749690909800203. |
| Label | URL |
|---|---|
| Click here for more information about this study:the study's four objectives were to determine the diagnostic criteria, characteristics, predictors, and 30-day outcomes of MINS(myocardial injury after noncardiac surgery, MINS). | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| standard-pressure pneumoperitoneum | Procedure | Using standard-pressure (between 12-16 mm Hg )pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy. |
|
| 17987573 | Background | Hakimi 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. |
| 12297911 | Background | Meininger 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. |
| 23579502 | Background | Yiannakopoulou 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. |
| 9013221 | Background | Sharma 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. |
| 16882427 | Background | Leduc LJ, Mitchell A. Intestinal ischemia after laparoscopic cholecystectomy. JSLS. 2006 Apr-Jun;10(2):236-8. |
| 11717720 | Background | de 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. |
| 24078502 | Background | Imamoglu M, Sapan L, Tekelioglu Y, Sarihan H. Long-term effects of elevated intra-abdominal pressure on testes an experimental model of laparoscopy. Urol J. 2013 Sep 26;10(3):953-9. |
| 9809953 | Background | Joris JL, Chiche JD, Canivet JL, Jacquet NJ, Legros JJ, Lamy ML. Hemodynamic changes induced by laparoscopy and their endocrine correlates: effects of clonidine. J Am Coll Cardiol. 1998 Nov;32(5):1389-96. doi: 10.1016/s0735-1097(98)00406-9. |
| 19696680 | Background | Russo A, Marana E, Viviani D, Polidori L, Colicci S, Mettimano M, Proietti R, Di Stasio E. Diastolic function: the influence of pneumoperitoneum and Trendelenburg positioning during laparoscopic hysterectomy. Eur J Anaesthesiol. 2009 Nov;26(11):923-7. doi: 10.1097/EJA.0b013e32832cb3c9. |
| 8797429 | Background | Sharma KC, Brandstetter RD, Brensilver JM, Jung LD. Cardiopulmonary physiology and pathophysiology as a consequence of laparoscopic surgery. Chest. 1996 Sep;110(3):810-5. doi: 10.1378/chest.110.3.810. No abstract available. |
| 7889585 | Background | Wahba RW, Beique F, Kleiman SJ. Cardiopulmonary function and laparoscopic cholecystectomy. Can J Anaesth. 1995 Jan;42(1):51-63. doi: 10.1007/BF03010572. |
| 25913587 | Background | Hanaoka M, Hara Y, Fujiogi M, Fujisawa N, Kawakami M, Shioiri S, Tanaka M, Yasuno M. Pulmonary edema after laparoscopic hepatectomy in a patient with Budd-Chiari syndrome-associated hepatocellular carcinoma. Asian J Endosc Surg. 2015 May;8(2):197-200. doi: 10.1111/ases.12152. |
| 25307158 | Background | Aydin V, Kabukcu HK, Sahin N, Mesci A, Arici AG, Kahveci G, Ozmete O. Comparison of pressure and volume-controlled ventilation in laparoscopic cholecystectomy operations. Clin Respir J. 2016 May;10(3):342-9. doi: 10.1111/crj.12223. Epub 2014 Nov 14. |
| 26144913 | Background | Lebowitz P, Yedlin A, Hakimi AA, Bryan-Brown C, Richards M, Ghavamian R. Respiratory gas exchange during robotic-assisted laparoscopic radical prostatectomy. J Clin Anesth. 2015 Sep;27(6):470-5. doi: 10.1016/j.jclinane.2015.06.001. Epub 2015 Jul 3. |
| 20306755 | Background | Kanwer DB, Kaman L, Nedounsejiane M, Medhi B, Verma GR, Bala I. Comparative study of low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy--a randomised controlled trial. Trop Gastroenterol. 2009 Jul-Sep;30(3):171-4. |
| 24503370 | Background | Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16. |
| 23667270 | Background | van Waes JA, Nathoe HM, de Graaff JC, Kemperman H, de Borst GJ, Peelen LM, van Klei WA; Cardiac Health After Surgery (CHASE) Investigators. Myocardial injury after noncardiac surgery and its association with short-term mortality. Circulation. 2013 Jun 11;127(23):2264-71. doi: 10.1161/CIRCULATIONAHA.113.002128. Epub 2013 May 10. |
| 22973364 | Background | Ozturk TC, Unluer E, Denizbasi A, Guneysel O, Onur O. Can NT-proBNP be used as a criterion for heart failure hospitalization in emergency room? J Res Med Sci. 2011 Dec;16(12):1564-71. |
| 23608621 | Background | Argyra E, Theodoraki K, Rellia P, Marinis A, Voros D, Polymeneas G. Atrial and brain natriuretic peptide changes in an experimental model of intra-abdominal hypertension. J Surg Res. 2013 Oct;184(2):937-43. doi: 10.1016/j.jss.2013.03.036. Epub 2013 Mar 31. |
| 22706835 | Background | Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Study Investigators; Devereaux PJ, Chan MT, Alonso-Coello P, Walsh M, Berwanger O, Villar JC, Wang CY, Garutti RI, Jacka MJ, Sigamani A, Srinathan S, Biccard BM, Chow CK, Abraham V, Tiboni M, Pettit S, Szczeklik W, Lurati Buse G, Botto F, Guyatt G, Heels-Ansdell D, Sessler DI, Thorlund K, Garg AX, Mrkobrada M, Thomas S, Rodseth RN, Pearse RM, Thabane L, McQueen MJ, VanHelder T, Bhandari M, Bosch J, Kurz A, Polanczyk C, Malaga G, Nagele P, Le Manach Y, Leuwer M, Yusuf S. Association between postoperative troponin levels and 30-day mortality among patients undergoing noncardiac surgery. JAMA. 2012 Jun 6;307(21):2295-304. doi: 10.1001/jama.2012.5502. |
| 25685845 | Background | Davarci I, Karcioglu M, Tuzcu K, Inanoglu K, Yetim TD, Motor S, Ulutas KT, Yuksel R. Evidence for negative effects of elevated intra-abdominal pressure on pulmonary mechanics and oxidative stress. ScientificWorldJournal. 2015;2015:612642. doi: 10.1155/2015/612642. Epub 2015 Jan 20. |
| 19608821 | Background | Awad H, Santilli S, Ohr M, Roth A, Yan W, Fernandez S, Roth S, Patel V. The effects of steep trendelenburg positioning on intraocular pressure during robotic radical prostatectomy. Anesth Analg. 2009 Aug;109(2):473-8. doi: 10.1213/ane.0b013e3181a9098f. |
| 18200624 | Background | Falabella A, Moore-Jeffries E, Sullivan MJ, Nelson R, Lew M. Cardiac function during steep Trendelenburg position and CO2 pneumoperitoneum for robotic-assisted prostatectomy: a trans-oesophageal Doppler probe study. Int J Med Robot. 2007 Dec;3(4):312-5. doi: 10.1002/rcs.165. |
| 20167583 | Background | Kalmar AF, Foubert L, Hendrickx JF, Mottrie A, Absalom A, Mortier EP, Struys MM. Influence of steep Trendelenburg position and CO(2) pneumoperitoneum on cardiovascular, cerebrovascular, and respiratory homeostasis during robotic prostatectomy. Br J Anaesth. 2010 Apr;104(4):433-9. doi: 10.1093/bja/aeq018. Epub 2010 Feb 18. |
| 19426238 | Background | Park EY, Koo BN, Min KT, Nam SH. The effect of pneumoperitoneum in the steep Trendelenburg position on cerebral oxygenation. Acta Anaesthesiol Scand. 2009 Aug;53(7):895-9. doi: 10.1111/j.1399-6576.2009.01991.x. Epub 2009 May 6. |
| 27724965 | Derived | Zhang X, Wei J, Song X, Zhang Y, Qian W, Sheng L, Shen Z, Yang L, Dong R, Gu W. Comparison of the impact of prolonged low-pressure and standard-pressure pneumoperitoneum on myocardial injury after robot-assisted surgery in the Trendelenburg position: study protocol for a randomized controlled trial. Trials. 2016 Oct 10;17(1):488. doi: 10.1186/s13063-016-1609-5. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |