Journal of minimally invasive gynecology · 2025
Safe Without Suction: Double-Blind Randomized Controlled Trial Challenges Routine Gastric Decompression in Laparoscopy.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Karlson Kristina, Gauf Annie, Voigt Petra, Yu Lulu, Yang Linda, Chaudhari Angela, Tsai Susan, Lee Jungwha, Milad Magdy P
Аннотация
OBJECTIVE: This study aimed to evaluate the necessity of intraoperative gastric decompression during gynecologic laparoscopy.
METHODS: This study is a double-blind randomized controlled trial in which participants undergoing any benign gynecologic laparoscopy procedure with umbilical entry were block randomized (1:1) to either receive gastric decompression or not. Individuals were screened for eligibility based on surgical scheduling for gynecologic laparoscopy undergoing umbilical entry. The intervention was performed after the patient was intubated and while the surgeon was out of the operating room to maintain blinding. At the time of laparoscopic entry, surgeons subjectively assessed the degree of stomach decompression, risk of gastric injury, and distance between the umbilicus and inferior gastric margin. A sample size calculation determined that 73 participants per group were needed.
RESULTS: From November 2023 to March 2025, 155 participants were consented to participate and 146 were enrolled and randomized. Participants in the study and control groups did not significantly vary based on age (37.8 vs 36.8), body mass index (27.3 vs 27.9), or procedure type. The primary outcome, stomach well decompressed, was achieved in 97.2% of participants in the study group without an orogastric (OG) tube and 98.5% in the control group with an OG tube (difference, -1.3%; 95% confidence interval, -8.8 to 6.2; p = .01 for noninferiority), with noninferiority margin set at -10%. There were no cases of gastric injury in both groups.
CONCLUSION: Routine gastric decompression during gynecologic laparoscopy with umbilical entry is not necessary for low-risk participants. Regardless of the placement of an OG tube, the stomach was adequately decompressed, not at risk of injury, and without negative postoperative participant experience.
METHODS: This study is a double-blind randomized controlled trial in which participants undergoing any benign gynecologic laparoscopy procedure with umbilical entry were block randomized (1:1) to either receive gastric decompression or not. Individuals were screened for eligibility based on surgical scheduling for gynecologic laparoscopy undergoing umbilical entry. The intervention was performed after the patient was intubated and while the surgeon was out of the operating room to maintain blinding. At the time of laparoscopic entry, surgeons subjectively assessed the degree of stomach decompression, risk of gastric injury, and distance between the umbilicus and inferior gastric margin. A sample size calculation determined that 73 participants per group were needed.
RESULTS: From November 2023 to March 2025, 155 participants were consented to participate and 146 were enrolled and randomized. Participants in the study and control groups did not significantly vary based on age (37.8 vs 36.8), body mass index (27.3 vs 27.9), or procedure type. The primary outcome, stomach well decompressed, was achieved in 97.2% of participants in the study group without an orogastric (OG) tube and 98.5% in the control group with an OG tube (difference, -1.3%; 95% confidence interval, -8.8 to 6.2; p = .01 for noninferiority), with noninferiority margin set at -10%. There were no cases of gastric injury in both groups.
CONCLUSION: Routine gastric decompression during gynecologic laparoscopy with umbilical entry is not necessary for low-risk participants. Regardless of the placement of an OG tube, the stomach was adequately decompressed, not at risk of injury, and without negative postoperative participant experience.