Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02654808
Other study ID # AAAQ6474
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date May 2017

Study information

Verified date August 2021
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare carbon dioxide (CO2) absorption during gynecologic laparoscopy using the AirSeal® valveless trocar system versus standard insufflation trocars at intra-abdominal pressures of 10 and 15 mmHg. The investigators hypothesize that with the AirSeal® valveless trocar system, gynecologic laparoscopy can be performed at a lower intra-abdominal pressure with a possible resultant decrease in CO2 absorption, while maintaining adequate visualization of the operative field for safe completion of surgery.


Description:

Three main factors affect patients' cardiopulmonary status during gynecologic laparoscopy: 1) degree of Trendelenburg tilt (25 - 30°), 2) carbon dioxide (CO2) absorption and 3) increased intra-abdominal pressure (10 -20 mmHg). Slight modifications to any or all of these three factors can lead to a significant decrease in morbidity. The AirSeal® valveless trocar system reduces CO2 absorption when compared to standard trocars during renal laparoscopy. Also, use of this trocar system provides a more stable intra-abdominal pressure when compared to standard trocars, a feature that could possibly allow for laparoscopic surgery to be performed at lower intra-abdominal pressures.


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date May 2017
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Any woman = 18 years of age undergoing a gynecologic laparoscopic procedure - Able to understand the consenting process and willing to participate in study Exclusion Criteria: - Patient unable to undergo laparoscopic procedure due to size of pathology or medical comorbidities - Emergent surgery

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AirSeal trocar
The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
Standard trocar
A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.

Locations

Country Name City State
United States Columbia University Medical Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
Columbia University SurgiQuest, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (16)

Bogani G, Uccella S, Cromi A, Serati M, Casarin J, Pinelli C, Ghezzi F. Low vs standard pneumoperitoneum pressure during laparoscopic hysterectomy: prospective randomized trial. J Minim Invasive Gynecol. 2014 May-Jun;21(3):466-71. doi: 10.1016/j.jmig.2013.12.091. Epub 2013 Dec 25. — View Citation

CONMED - Transforming Laparosopic Surgery. Available at: http://www.conmed.com/en/hybrid-product-landing-pages/airseal. Retrieved January 12, 2018.

Esmat ME, Elsebae MM, Nasr MM, Elsebaie SB. Combined low pressure pneumoperitoneum and intraperitoneal infusion of normal saline for reducing shoulder tip pain following laparoscopic cholecystectomy. World J Surg. 2006 Nov;30(11):1969-73. — View Citation

Gerges FJ, Kanazi GE, Jabbour-Khoury SI. Anesthesia for laparoscopy: a review. J Clin Anesth. 2006 Feb;18(1):67-78. Review. — View Citation

Herati AS, Andonian S, Rais-Bahrami S, Atalla MA, Srinivasan AK, Richstone L, Kavoussi LR. Use of the valveless trocar system reduces carbon dioxide absorption during laparoscopy when compared with standard trocars. Urology. 2011 May;77(5):1126-32. doi: 10.1016/j.urology.2010.06.052. Epub 2010 Oct 2. — View Citation

Joshipura VP, Haribhakti SP, Patel NR, Naik RP, Soni HN, Patel B, Bhavsar MS, Narwaria MB, Thakker R. A prospective randomized, controlled study comparing low pressure versus high pressure pneumoperitoneum during laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2009 Jun;19(3):234-40. doi: 10.1097/SLE.0b013e3181a97012. — View Citation

Kandil TS, El Hefnawy E. Shoulder pain following laparoscopic cholecystectomy: factors affecting the incidence and severity. J Laparoendosc Adv Surg Tech A. 2010 Oct;20(8):677-82. doi: 10.1089/lap.2010.0112. — View Citation

Motew M, Ivankovich AD, Bieniarz J, Albrecht RF, Zahed B, Scommegna A. Cardiovascular effects and acid-base and blood gas changes during laparoscopy. Am J Obstet Gynecol. 1973 Apr 1;115(7):1002-12. — View Citation

Ng CS, Gill IS, Sung GT, Whalley DG, Graham R, Schweizer D. Retroperitoneoscopic surgery is not associated with increased carbon dioxide absorption. J Urol. 1999 Oct;162(4):1268-72. — View Citation

Özdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warlé MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016 May;30(5):2049-65. doi: 10.1007/s00464-015-4454-9. Epub 2015 Aug 15. Review. — View Citation

Park JS, Ahn EJ, Ko DD, Kang H, Shin HY, Baek CH, Jung YH, Woo YC, Kim JY, Koo GH. Effects of pneumoperitoneal pressure and position changes on respiratory mechanics during laparoscopic colectomy. Korean J Anesthesiol. 2012 Nov;63(5):419-24. doi: 10.4097/kjae.2012.63.5.419. Epub 2012 Nov 16. — View Citation

Rauh R, Hemmerling TM, Rist M, Jacobi KE. Influence of pneumoperitoneum and patient positioning on respiratory system compliance. J Clin Anesth. 2001 Aug;13(5):361-5. — View Citation

Sefr R, Puszkailer K, Jagos F. Randomized trial of different intraabdominal pressures and acid-base balance alterations during laparoscopic cholecystectomy. Surg Endosc. 2003 Jun;17(6):947-50. Epub 2003 Mar 14. — View Citation

Tan PL, Lee TL, Tweed WA. Carbon dioxide absorption and gas exchange during pelvic laparoscopy. Can J Anaesth. 1992 Sep;39(7):677-81. — View Citation

Vijayaraghavan N, Sistla SC, Kundra P, Ananthanarayan PH, Karthikeyan VS, Ali SM, Sasi SP, Vikram K. Comparison of standard-pressure and low-pressure pneumoperitoneum in laparoscopic cholecystectomy: a double blinded randomized controlled study. Surg Laparosc Endosc Percutan Tech. 2014 Apr;24(2):127-33. doi: 10.1097/SLE.0b013e3182937980. — View Citation

Wolf JS Jr, Monk TG, McDougall EM, McClennan BL, Clayman RV. The extraperitoneal approach and subcutaneous emphysema are associated with greater absorption of carbon dioxide during laparoscopic renal surgery. J Urol. 1995 Sep;154(3):959-63. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg This outcome is measured by calculating the CO2 elimination rate. CO2 absorption rates were obtained at 15 and 60 minutes during each case and an average value was calculated per case. In cases < 60 minutes, the CO2 absorption rate at 15 minutes will be used. 15 minutes & 60 minutes from surgery start time
Secondary Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars Surgeon Questionnaire (0 "not adequate" -10 "optimal") is designed to evaluate the visualization of operative field by surgeon during colpotomy. At the end of surgery (approximately 1 hour)
Secondary Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars Anesthesia Questionnaire (0 "no problem" - 2 "very problematic) is designed to evaluate the the level of difficulty in maintaining adequate end-tidal CO2 (etCO2). At the end of surgery (approximately 1 hour)
Secondary Median VAS Pain Score When Using AirSeal® Versus Standard Trocars Visual Analog Scale (VAS) Pain Score (0 "no pain" - 10 "worst pain") is designed to evaluate the level of pain post-surgery. 4 to 6 hours, and 12 to 23 hours following surgery
Secondary Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg This outcome is measured by calculating the CO2 elimination rate. 15 minutes & 60 minutes from surgery start time
See also
  Status Clinical Trial Phase
Completed NCT02567838 - Lidocaine Gel During Transrectal Sonography Phase 3
Completed NCT02596425 - Pulmonary Recruitment Maneuver for Postlaparoscopic Shoulder Pain Phase 3
Withdrawn NCT00734812 - Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy Phase 3
Completed NCT02811081 - Effective Maneuver for Post-laparoscopic Shoulder Pain N/A
Completed NCT00456924 - Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914 Phase 2
Completed NCT02357251 - Enhanced Recovery After Surgery: A RCT of Perioperative Management of Gynecologic Patients N/A
Completed NCT00526331 - Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy Phase 4
Completed NCT02729272 - Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy N/A