Prostatic NeoplasmsNCT02600481
Impacts of Different Pressure Pneumoperitoneum on Myocardial and Pulmonary Injuries After Robot-assisted Surgery
A study testing low-pressure pneumoperitoneum and standard-pressure pneumoperitoneum in people with Prostatic Neoplasms and Urinary Bladder Neoplasms, run by Huadong Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prostatic Neoplasms, Urinary Bladder Neoplasms
- What is being tested?
- low-pressure pneumoperitoneum and standard-pressure pneumoperitoneum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Rong Dong, Doctor, +86-21-64370045, sally9132@163.com
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Prostatic Neoplasms, Urinary Bladder Neoplasms
- Being tested
- low-pressure pneumoperitoneum, standard-pressure pneumoperitoneum
- Keywords
- standard-pressure pneumoperitoneum, prolonged pneumoperitoneum, myocardial injuries, troponin T(TnT), Trendelenburg position, chest CT scan, low-pressure pneumoperitoneum, robot-assisted surgery
- Medical subject headings
- Prostatic Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-pressure pneumoperitoneumProcedure or surgery
Using low-pressure(between 7-10 mm Hg ) pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy.
standard-pressure pneumoperitoneumProcedure or surgery
Using standard-pressure (between 12-16 mm Hg )pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy.
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: Procedure: low-pressure pneumoperitoneum |
| 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; Receives: Procedure: standard-pressure pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin T level is set as the marker of myocardial injuries after robot-assisted surgeries
Measured: Within the first 24 hours after prolonged robot-assisted surgeries
Secondary outcomes (1)
Chest CT scan is used to determine pulmonary complications
Measured: On the third day after prolonged robot-assisted surgeries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huadong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital
- Responsible party
- Sponsor
- Investigators
- Weidong Gu, Doctor, Study chair, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600481
- Sponsor's protocol ID
- 2015K060
- Status last verified
- Nov 2015
- First submitted
- 5 Nov 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20428292Orvieto MA, Patel VR. Evolution of robot-assisted radical prostatectomy. Scand J Surg. 2009;98(2):76-88. doi: 10.1177/145749690909800203.
PubMed 19799045Hakimi 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.
PubMed 17987573Meininger 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.
PubMed 12297911Yiannakopoulou 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.
PubMed 23579502Sharma 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.
PubMed 9013221Leduc LJ, Mitchell A. Intestinal ischemia after laparoscopic cholecystectomy. JSLS. 2006 Apr-Jun;10(2):236-8.
PubMed 16882427de 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.
PubMed 11717720Imamoglu 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.
PubMed 24078502Joris 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.
PubMed 9809953Russo 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.
PubMed 19696680Sharma 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.
PubMed 8797429Wahba RW, Beique F, Kleiman SJ. Cardiopulmonary function and laparoscopic cholecystectomy. Can J Anaesth. 1995 Jan;42(1):51-63. doi: 10.1007/BF03010572.
PubMed 7889585Hanaoka 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.
PubMed 25913587Aydin 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.
PubMed 25307158
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02600481
- Acronym / sponsor ID
- 2015K060
- Conditions
- Prostatic Neoplasms, Urinary Bladder Neoplasms
- Keywords
- standard-pressure pneumoperitoneum, prolonged pneumoperitoneum, myocardial injuries, troponin T(TnT), Trendelenburg position, chest CT scan, low-pressure pneumoperitoneum, robot-assisted surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Huadong HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Nov 2015 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-pressure pneumoperitoneum group | Experimental | Procedure: low-pressure pneumoperitoneumSubjects 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 | Procedure: standard-pressure pneumoperitoneumSubjects 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; |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| low-pressure pneumoperitoneumUsing low-pressure(between 7-10 mm Hg ) pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy. | Procedure or surgery | low-pressure pneumoperitoneum group |
| standard-pressure pneumoperitoneumUsing standard-pressure (between 12-16 mm Hg )pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy. | Procedure or surgery | standard-pressure pneumoperitoneum group |
Primary outcome
Troponin T level is set as the marker of myocardial injuries after robot-assisted surgeries
Time frame: Within the first 24 hours after prolonged robot-assisted surgeries
1 secondary outcome
Chest CT scan is used to determine pulmonary complications
Time frame: On the third day after prolonged robot-assisted surgeries
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
- Background: PubMed 20428292Finkelstein 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.
- Background: PubMed 19799045Orvieto MA, Patel VR. Evolution of robot-assisted radical prostatectomy. Scand J Surg. 2009;98(2):76-88. doi: 10.1177/145749690909800203.
- Background: PubMed 17987573Hakimi 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.
- Background: PubMed 12297911Meininger 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.
- Background: PubMed 23579502Yiannakopoulou 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.
- Background: PubMed 9013221Sharma 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.
- Background: PubMed 16882427Leduc LJ, Mitchell A. Intestinal ischemia after laparoscopic cholecystectomy. JSLS. 2006 Apr-Jun;10(2):236-8.
- Background: PubMed 11717720de 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.
- Background: PubMed 24078502Imamoglu 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.
- Background: PubMed 9809953Joris 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.
- Background: PubMed 19696680Russo 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.
- Background: PubMed 8797429Sharma 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.
- 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).Link provided by the sponsor.
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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. This study is not recruiting at the moment.
Weidong Gu, Doctor study chair
Huadong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-pressure pneumoperitoneum and standard-pressure pneumoperitoneum in people with Prostatic Neoplasms and Urinary Bladder Neoplasms, run by Huadong Hospital at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 10 Nov 2015. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weidong Gu, Doctor (+86-21-62483180 ext. 70603, mcwgwd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Troponin T level is set as the marker of myocardial injuries after robot-assisted surgeries (time frame: Within the first 24 hours after prolonged robot-assisted surgeries). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02600481, which also lists 28 linked publications.
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 10 Nov 2015.