Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338865
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-03-21
Brief Title:
Short Title Standard vs Lower Pressure Pneumoperitoneum
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Standard vs Lower Pressure Pneumoperitoneum in Laparoscopic Gynecologic Surgery A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to investigate the effect of varying insufflation pressures on post-operative pain and adequacy of surgical field visualization among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon
Detailed Description:
This will be a single-center single-blinded randomized controlled trial evaluating the impact of lower pressure pneumoperitoneum on post-operative pain and surgical field visualization among patients undergoing laparoscopic gynecologic surgery The investigators hypothesize that lower insufflation pressures will decrease post-operative pain in the immediate post-operative period without compromising surgical field visualization The study will include 3 groups corresponding to varying insufflation pressures 15mmHg standard 12mmHg and 10mmHg Participants will be 111 allocated to the 15mmHg 12mmHg or 10mmHg groups parallel design by block randomization
Given inherent differences in how pneumoperitoneum is maintained during conventional versus robotic-assisted laparoscopic surgery the investigators will be enrolling patients in two separate arms depending on their planned procedure
1 Standard vs Lower Pressure Pneumoperitoneum in Conventional Laparoscopic Gynecologic Surgery
2 Standard vs Lower Pressure Pneumoperitoneum in Robotic-Assisted Laparoscopic Gynecologic Surgery
The methodology for the two arms will be otherwise identical
Given inherent differences in how pneumoperitoneum is maintained during conventional versus robotic-assisted laparoscopic surgery the investigators will be enrolling patients in two separate arms depending on their planned procedure
1 Standard vs Lower Pressure Pneumoperitoneum in Conventional Laparoscopic Gynecologic Surgery
2 Standard vs Lower Pressure Pneumoperitoneum in Robotic-Assisted Laparoscopic Gynecologic Surgery
The methodology for the two arms will be otherwise identical
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None