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.
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 1:1 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Veress needle abdominal entry technique description: a 5 mm incision is made in the umbilicus. Next, a Veress needle is used to enter the peritoneal cavity and inflate the abdomen to 15 mm Hg. Once the abdomen is fully insufflated, a 10 mm trocar is placed using optical guidance.
Cedars Sinai Medical Center
Los Angeles, California, United States
RECRUITINGInsufflation time
The time it takes to insufflate the abdominal cavity to 15 mm Hg.
Time frame: Intraoperative
Success upon peritoneal entry
Successful abdominal entry in the first trial
Time frame: Intraoperative
Intraoperative complications
\- Intraoperative complications upon peritoneal entry
Time frame: Intraoperative
Postoperative complications
Any postoperative complications
Time frame: Postoperative period within 30 days of surgery
Patients pain scores
* First reported pain score in PACU using the numerical rating scale (0-10). * Last reported pain score in PACU prior to discharge using the numerical rating scale (0-10).
Time frame: Day of surgery, postoperatively and before discharge
Analgesics use
\- Total analgesic requirements in PACU
Time frame: Day of surgery, postoperatively and before discharge
Length of hospital stay
\- Length of stay- from arrival to PACU to discharge home)
Time frame: Day of surgery, postoperatively and before discharge. In rare cases, hospital stay will be longer than one day.
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