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Surgeon Perception of Gastric Decompression at Time of Gynecologic Laparoscopy
The goal of this clinical trial is to test whether it is necessary to decompress the stomach during gynecologic laparoscopy. The main questions it aims to answer are: * Is there appropriate visualization during surgery without stomach decompression? * Can the surgeon tell the stomach is decompressed? * Is the stomach at risk for injury during surgery? * How is the patient's postoperative experience affected? Participants will undergo their planned surgery as usual and will be asked to complete log about their recovery for the first week after surgery. Researchers will compare patients who have their stomach decompressed during surgery to those who do not undergo stomach decompression to see if it is necessary.
Conditions:
🦠 Gynecologic Surgical Procedures 🦠 Gastric Injury 🦠 Aspiration 🦠 Nausea, Postoperative 🦠 Postoperative Complications 🦠 Enhanced Recovery After Surgery 🦠 Laparoscopy
🗓️ Study Start (Actual) 20 November 2023
🗓️ Primary Completion (Estimated) November 2024
✅ Study Completion (Estimated) January 2025
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chicago, Illinois, United States
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Undergoing gynecologic laparoscopy for the following indications: hysterectomy, adnexal surgery, benign and malignant tumors or disease, diagnostic purposes, lysis of adhesions, and pelvic pain.
    • * Surgery being performed by gynecologic surgeon with or without minimally invasive gynecologist certification, gynecologic oncologists, urogynecologists, and reproductive endocrinologists.

    Exclusion Criteria:

    • * Entry sites other than umbilical
    • * Planned or high suspicion for bowel surgery
    • * Anticipated surgical time \>4 hours
    • * Known diagnosis of gastric reflux disease or peptic ulcer disease
    • * Prior history of gastric or esophageal surgery excluding endoscopy
    • * Day of surgery emesis events
    • * Difficult intubation determined by anesthesia
    • * Intrauterine pregnancy
    • * Chronic lung disease
    • * Individuals with smoking history.
    • * Individuals who do not speak English due to limitations in ability to reliably obtain informed consent in their primary language.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 November 2023
  • First Submitted that Met QC Criteria 13 November 2023
  • First Posted 18 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 November 2023
  • Last Update Posted 28 November 2023
  • Last Verified November 2023
I'm interested ...!!