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Pneumoperitoneum Management With Low vs. Higher Pressure

NCT03128281 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-05-30

No results posted yet for this study

Summary

The goal of this clinical research study is to compare the level of pain 2 hours after surgery in patients after the use of the AirSeal® Insufflation System (AIS) at a high or low pressure setting or the standard insufflator (the conventional insufflation system, or CIS). "Insufflation" is the creation of a pressure barrier of air/gas within the abdomen that allows the surgeon more space to work in.

Conditions

  • Malignant Neoplasms of Female Genital Organs

Interventions

BEHAVIORAL

Questionnaires

Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge. Questionnaires ask about pain level and any drugs taken for it. It should take about 5 minutes to complete.

DEVICE

Conventional Insufflation System (CIS)

CIS with pressure target of 15±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.

DEVICE

ConMed AirSeal Insufflation System (AIS) at Low Pressure

AIS with an insufflation pressure target of 9±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.

DEVICE

ConMed AirSeal Insufflation System (AIS) at Higher Pressure

AIS with an insufflation pressure target of 15±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.

Sponsors & Collaborators

  • CONMED Corporation

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Pedro T. Ramirez, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2021-07-31
Completion
2022-07-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03128281 on ClinicalTrials.gov