Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305975
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-02-22
Brief Title:
Blunt Fascial vs Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Blunt Fascial vs Veress Needle Peritoneal Entry 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:
BluntFascial
Brief Summary:
This study aims to investigate the effect of two peritoneal entry techniques on intraoperative and post-operative outcomes among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon Patients will be randomized to either blunt fascial or veress needle peritoneal entry Insufflation times failed entries complications and post-operative pain scores will be collected
The investigators hypothesize that the blunt entry technique will be associated with shorter insufflation times and similar intraoperative and postoperative outcomes compared with the veress needle entry technique
Primary Objective To evaluate the insufflation times and success upon peritoneal entry according to peritoneal entry technique
Secondary Objectives To evaluate the surgical outcomes and patients pain scores according to peritoneal entry technique
The investigators hypothesize that the blunt entry technique will be associated with shorter insufflation times and similar intraoperative and postoperative outcomes compared with the veress needle entry technique
Primary Objective To evaluate the insufflation times and success upon peritoneal entry according to peritoneal entry technique
Secondary Objectives To evaluate the surgical outcomes and patients pain scores according to peritoneal entry technique
Detailed Description:
This will be a single-center single-blinded randomized controlled trial evaluating the impact of peritoneal entry technique on insufflation times entry failure post-operative pain and surgical outcomes among patients undergoing laparoscopic gynecologic surgery The investigators hypothesize that the blunt fascial entry technique will be associated with shorter insufflation times with no effect on other surgical outcomes The study will include 2 groups corresponding to the entry techniques blunt facial entry and Veress needle entry Participants will be 11 allocated to each technique by block randomization
Blunt fascial entry technique description a 5 mm incision is made in the umbilicus Next a curved Kelly forceps is used to open the fascia and if possible the peritoneum The Kelly forceps are then used to expand the opening to a 10 mm diameter A 5 mm trocar is placed into the fascial hole and used to quickly insufflate the abdomen to 15 mm Hg Once the abdomen is fully insufflated a 10 mm trocar is placed using optical guidance
Blunt fascial entry technique description a 5 mm incision is made in the umbilicus Next a curved Kelly forceps is used to open the fascia and if possible the peritoneum The Kelly forceps are then used to expand the opening to a 10 mm diameter A 5 mm trocar is placed into the fascial hole and used to quickly insufflate the abdomen to 15 mm Hg Once the abdomen is fully insufflated a 10 mm trocar is placed using optical guidance
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