NCT03128281 - Pneumoperitoneum Management With Low vs. Higher Pressure | Biotech Hunter

Timeline

Start Date

July 31, 2018

Primary Completion Date

July 31, 2021

Study Completion Date

July 31, 2022

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.