Design: A double-masked, RCT with both participants and surgeons blinded to assignment (study group: no gastric decompression vs. control: gastric decompression). The study was approved by the Northwestern University IRB and registered with clinicaltrials.gov.
Setting: Urban academic medical center
Patients or Participants: Sequential, low-risk participants undergoing all types of gynecologic laparoscopy with umbilical entry were included. From November 2023 to March 2024, 44 participants have completed the study. Enrollment is ongoing. Using a superiority design, we calculated 144 participants is needed to demonstrate a 20% difference between groups (2-sided alpha 0.05, 80% power).
Interventions: A block randomization schedule was implemented by use of sequentially numbered opaque envelopes assigned after an uneventful intubation. The surgeon assessed adequacy of decompression.
Measurements and Main Results: Participants ranged in age from 24 to 57 years old and BMI from 18.6 to 43 kg/m2. Four surgeons were included with a wide range of cases from diagnostic (1), adnexal/adhesive/endometriosis surgery (19), myomectomy (6), and hysterectomy (18). The stomach was adequately decompressed in all participants (study group: 21/21, control: 23/23). There were no cases of injury, and the stomach was never identified to be at risk. The surgeon incorrectly thought an orogastric tube was present in 48% (10/23) of participants. There was no significant difference between groups in percentage of cases with accurate assessment of gastric intubation (p=0.305). Stomach decompression was rated “excellent” or “good” in 74% (17/23) of cases without gastric intubation (p=0.53). There was a correlation between BMI and distance between the umbilicus and the greater curvature of the stomach (r=0.65).
Conclusion: Routine gastric decompression during gynecologic laparoscopy with umbilical entry is potentially unnecessary. Regardless of group assignment, the stomach was never at risk of injury and was adequately decompressed in all participants.
Karlson, KLM*1, Gauf, A2, Emeka, AA3, Chaudhari, A4, Tsai, SC4, Voigt, PC4, Yang, LC4, Yu, L4, Milad, MP4. 1Gynecologic Surgery and Obstetrics, Keesler Air Force Base, Biloxi, MS; 2Obstetrics and Gynecology, Northwestern Medicine, Feinberg School of Medicine, Chicago, IL; 3Obstetrics & Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL; 4Center for Complex Gynecology, Northwestern Medicine, Chicago, IL
