Impacts of Different Pressure Pneumoperitoneum on Myocardial and Pulmonary Injuries After Robot-assisted Surgery

NCT02600481 | Unknown

• 1 other identifier: 2015K060
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Chest CT scan is used to determine pulmonary complications

  On the third day after prolonged robot-assisted surgeries

Study Arms (2)

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;

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;

Procedure: standard-pressure pneumoperitoneum

Interventions

low-pressure pneumoperitoneum PROCEDURE

Using low-pressure(between 7-10 mm Hg ) pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy.

low-pressure pneumoperitoneum group

standard-pressure pneumoperitoneum PROCEDURE

Using standard-pressure (between 12-16 mm Hg )pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy.

standard-pressure pneumoperitoneum group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huadong Hospital: lead
• Ruijin Hospital: collaborator

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (28)

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  PMID: 27724965 DERIVED

Related Links

• 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).

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases

Study Officials

• Weidong Gu, Doctor

  Huadong Hospital

  STUDY CHAIR

Central Study Contacts

Weidong Gu, Doctor

CONTACT

+86-21-62483180; mcwgwd@163.com

Xixue Zhang, Master

CONTACT

+86-21-62483180; zxxdoc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 9, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: November 10, 2015

Record last verified: 2015-11

Locations

CN (1)