Laparoscopic Surgery
Conditions
Keywords
Abdominal entry, Laparoscopy, Insufflation time, Postoperative pain, Safety
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.
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 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.
Interventions
PROCEDUREBlunt fascial abdominal entry
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.
PROCEDUREVeress needle abdominal entry
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.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. 18 years of age or older 4. Undergoing conventional laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.
Exclusion criteria
1. Pregnancy 2. Urgent/non-scheduled surgery 3. Non-eligible for umbilical entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insufflation time | Intraoperative | The time it takes to insufflate the abdominal cavity to 15 mm Hg. |
| Success upon peritoneal entry | Intraoperative | Successful abdominal entry in the first trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients pain scores | Day of surgery, postoperatively and before discharge | * 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). |
| Intraoperative complications | Intraoperative | \- Intraoperative complications upon peritoneal entry |
| Length of hospital stay | Day of surgery, postoperatively and before discharge. In rare cases, hospital stay will be longer than one day. | \- Length of stay- from arrival to PACU to discharge home) |
| Analgesics use | Day of surgery, postoperatively and before discharge | \- Total analgesic requirements in PACU |
| Postoperative complications | Postoperative period within 30 days of surgery | Any postoperative complications |
Countries
United States
Contacts
Primary ContactRaanan Meyer, MD
Backup ContactKacey Hamilton
Outcome results
None listed