Emad Mikhail1, Nupur Tamhane2, Papri Sarkar2, Elisabeth Sappenfield3, Jean Paul Tanner4, Anthony N Imudia2. 1. Department of Obstetrics and Gynecology (Drs. Mikhail, Tamhane, Sarkar, and Imudia), University of South Florida, Morsani College of Medicine, Tampa, Florida. Electronic address: emikhail@health.usf.edu. 2. Department of Obstetrics and Gynecology (Drs. Mikhail, Tamhane, Sarkar, and Imudia), University of South Florida, Morsani College of Medicine, Tampa, Florida. 3. Department of Obstetrics and Gynecology (Dr. Sappenfield), Hartford Hospital, Hartford, Connecticut. 4. Department of Community and Family Health (Dr. Tanner), College of Public Health, University of South Florida, Tampa, Florida.
Abstract
STUDY OBJECTIVE: To compare the time and number of attempts needed for successful Veress needle entry during laparoscopic surgery using concomitant versus subsequent CO2 insufflation approaches. DESIGN: Randomized controlled trial. SETTING:University teaching hospital. PATIENTS: One hundred consecutive patients scheduled for laparoscopic surgery by 2 high-volume laparoscopic surgeons were screened and randomized, and 95 of these were included in the final analysis. Ninety (45 in each group) was the precalculated priori number of patients needed to detect a 50% difference in the time (seconds) to obtain adequate insufflation with 90% power and alpha of 5%. INTERVENTIONS: Patients were randomized to either Veress needle entry with concomitant (Con) or subsequent (Sub) CO2 insufflation. MEASUREMENTS AND MAIN RESULTS:Forty-six patients were randomized to the Con group and 49 to the Sub group. Patient age, body mass index, prior surgical history, presence of adhesions, and type of procedure performed were similar between both groups. The median time required for adequate insufflation in the Con group was 103.5 seconds (Q1-Q3, 80.0-130.0) compared with 113.0 seconds (Q1-Q3, 102.0-144.0) in Sub group (p = .16). Approximately 89% (95% confidence interval, 80.1%-98.1%) of patients in Con group achieved successful entry in the first attempt compared with only 67% (95% confidence interval, 54.2%-80.0%) in Sub group (p = .01). The incidence of preperitoneal insufflation and failed entry was comparable between the 2 groups. No patient developed solid organ, visceral, or vascular injuries; gas embolism; or case conversion to laparotomy in relation to the Veress needle entry technique. CONCLUSION: Veress needle entry with concomitant CO2 insufflation was associated with a higher rate of successful entry during the first attempt of Veress needle insertion. The total time required for insufflation and rates of complications between the 2 techniques were similar.
RCT Entities:
STUDY OBJECTIVE: To compare the time and number of attempts needed for successful Veress needle entry during laparoscopic surgery using concomitant versus subsequent CO2 insufflation approaches. DESIGN: Randomized controlled trial. SETTING: University teaching hospital. PATIENTS: One hundred consecutive patients scheduled for laparoscopic surgery by 2 high-volume laparoscopic surgeons were screened and randomized, and 95 of these were included in the final analysis. Ninety (45 in each group) was the precalculated priori number of patients needed to detect a 50% difference in the time (seconds) to obtain adequate insufflation with 90% power and alpha of 5%. INTERVENTIONS:Patients were randomized to either Veress needle entry with concomitant (Con) or subsequent (Sub) CO2 insufflation. MEASUREMENTS AND MAIN RESULTS: Forty-six patients were randomized to the Con group and 49 to the Sub group. Patient age, body mass index, prior surgical history, presence of adhesions, and type of procedure performed were similar between both groups. The median time required for adequate insufflation in the Con group was 103.5 seconds (Q1-Q3, 80.0-130.0) compared with 113.0 seconds (Q1-Q3, 102.0-144.0) in Sub group (p = .16). Approximately 89% (95% confidence interval, 80.1%-98.1%) of patients in Con group achieved successful entry in the first attempt compared with only 67% (95% confidence interval, 54.2%-80.0%) in Sub group (p = .01). The incidence of preperitoneal insufflation and failed entry was comparable between the 2 groups. No patient developed solid organ, visceral, or vascular injuries; gas embolism; or case conversion to laparotomy in relation to the Veress needle entry technique. CONCLUSION: Veress needle entry with concomitant CO2 insufflation was associated with a higher rate of successful entry during the first attempt of Veress needle insertion. The total time required for insufflation and rates of complications between the 2 techniques were similar.
Authors: Riley E Reynolds; Benjamin P Wankum; Sean J Crimmins; Mark A Carlson; Benjamin S Terry Journal: Surg Endosc Date: 2021-01-22 Impact factor: 4.584