RECRUITING

Short Title: Standard vs. Lower Pressure Pneumoperitoneum

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to investigate the effect of varying insufflation pressures on post-operative pain and adequacy of surgical field visualization among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon.

Official Title

Standard vs. Lower Pressure Pneumoperitoneum in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial

Quick Facts

Study Start:2024-05-03
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06338865

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion 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 laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.
  1. * Pregnancy
  2. * Urgent/non-scheduled surgery
  3. * Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure)
  4. * Baseline opioid use
  5. * Allergy or intolerance to bupivacaine (or amide class of anesthetics), oxycodone, acetaminophen, or ibuprofen
  6. * Planned post-operative admission

Contacts and Locations

Study Contact

Rebecca Schneyer, MD
CONTACT
914-391-2604
rebecca.schneyer@cshs.org
Rebekah Odum, BSN
CONTACT
rebekah.odum@cshs.org

Principal Investigator

Matthew Siedhoff, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

  • Matthew Siedhoff, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

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

Study Start Date2024-05-03
Study Completion Date2027-04

Study Record Updates

Study Start Date2024-05-03
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • laparoscopic surgery
  • insufflation
  • pneumoperitoneum
  • gynecologic surgery
  • postoperative pain
  • robotic surgery

Additional Relevant MeSH Terms

  • Laparoscopic Surgery