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Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies

NCT ID: NCT02114164

Last Updated: 2021-11-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-07-15

Brief Summary

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The AirSeal® System will allow for lower carbon dioxide (CO2) absorption rates than the standard Endopath System.

Detailed Description

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The primary observation to be made is the level of carbon dioxide in the arterial blood, specifically when the patient is insufflated and deflated during the surgery. As a result of the consistent pressure that the AirSeal® system maintains, carbon dioxide will be absorbed in lower levels when compared to the standard of care systems in which fluctuations in intra-peritoneum pressure are seen.

Conditions

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Prostate Cancer Pneumoperitoneum

Keywords

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AirSeal Trocar Carbon Dioxide Exchange and Absorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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AirSeal System

This group receives the AirSeal System for intraoperative insufflation.

Group Type ACTIVE_COMPARATOR

AirSeal System

Intervention Type DEVICE

To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.

Standard Endopath

This group receives the Standard Endopath Trocar for intraoperative insufflation.

Group Type ACTIVE_COMPARATOR

Standard Endopath

Intervention Type DEVICE

This group receives the Standard Endopath Trocar for intraoperative insufflation.

Interventions

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AirSeal System

To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.

Intervention Type DEVICE

Standard Endopath

This group receives the Standard Endopath Trocar for intraoperative insufflation.

Intervention Type DEVICE

Other Intervention Names

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Valve-free Trocar Endopath Trocar

Eligibility Criteria

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Inclusion Criteria

* Age\>18
* Eligible and elect to undergo robotic prostatectomy surgery @ OhioHealth Dublin Methodist Hospital

Exclusion Criteria

* Age \< 18
* Emergency surgery
* Ascites
* BMI\>44 or \<18
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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SurgiQuest, Inc.

INDUSTRY

Sponsor Role collaborator

OhioHealth

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronney Abaza, MD,FACS

Role: PRINCIPAL_INVESTIGATOR

OhioHealth

Locations

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Dublin Methodist Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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Abaza R, Martinez O, Murphy C. Randomized Controlled Comparison of Valveless Trocar (AirSeal) vs Standard Insufflator with Ultralow Pneuomoperitoneum During Robotic Prostatectomy. J Endourol. 2021 Jul;35(7):1020-1024. doi: 10.1089/end.2020.1025. Epub 2021 Jan 21.

Reference Type DERIVED
PMID: 33349135 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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OH1-13-00489

Identifier Type: -

Identifier Source: org_study_id