← Back to Search

Procedure

Gastric Decompression for Gynecologic Surgery

N/A

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing gynecologic laparoscopy for the following indications: hysterectomy, adnexal surgery, benign and malignant tumors or disease, diagnostic purposes, lysis of adhesions, and pelvic pain.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of surgery

Awards & highlights

Study Summary

This trial will test if it's necessary to decompress the stomach during gynecologic laparoscopy to improve surgery and patient recovery.

Who is the study for?

This trial is for individuals scheduled for gynecologic laparoscopy, including procedures like hysterectomy and surgery on ovaries or fallopian tubes. Surgeons involved range from general to specialized gynecologists. Participants must follow standard recovery protocols and are willing to log their post-surgery experience.Check my eligibility

What is being tested?

The study tests if stomach decompression during gynecologic laparoscopy is necessary. It compares the surgical view, risk of stomach injury, and patient recovery between those with and without this procedure.See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include discomfort from the gastric tube insertion (either through mouth or nose), possible sore throat, nasal irritation, or aspiration risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having a laparoscopy for a gynecological reason like surgery or to diagnose a condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adequate gastric decompression

Gastric injury

Secondary outcome measures

Degree of stomach decompression

Entry proximity

Gastric injury risk assessment

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Gastric decompressionExperimental Treatment1 Intervention

Placement of the nasogastric or orogastric tube will occur after intubation while surgeons are scrubbing and out of the room to maintain blinding. At the end of surgery, the nasogastric or orogastric tube will be removed prior to removal of the surgical drapes to ensure the surgeon remains blinded. Patients will then be returned to routine post-operative care as otherwise planned or necessitated by surgery.

Group II: No gastric decompressionActive Control1 Intervention

No placement of gastric decompression tube.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

916,937 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there available slots in this research protocol?

"Affirmative. According to information hosted on clinicaltrials.gov, this research is presently enrolling participants, who must be sourced from two medical centres for a total of 150 individuals. The study first appeared online on November 20th 2023 and was last updated 2 days later."

Answered by AI

How does this trial aim to advance clinical research?

"This trial's primary endpoint is to gauge the extent of gastric injury, with secondary outcomes being the proximity between entry points and stomach on abdominal incision, post-operative complications potentially related to gastric decompression as per medical record reviews, and accurate establishment of orogastric or nasogastric tubes during surgery. These metrics will be observed over a period of time."

Answered by AI

How many people have opted to join this research endeavor?

"Affirmative, the clinicaltrials.gov listing discloses that this trial is currently enrolling participants. It was first uploaded on November 20th of 2023 and has been recently updated as of November 22nd of 2021; 150 people are required for two distinct medical facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Surgeon Perception of Gastric Decompression at Time of Gynecologic Laparoscopy

Magdy Milad, MD 2023. "Surgeon Perception of Gastric Decompression at Time of Gynecologic Laparoscopy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06137976.