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Procedure
Gastric Bypass vs Gastrojejunostomy for Gastric Outlet Obstruction
N/A
Recruiting
Led By G. Paul Wright, MD
Research Sponsored by Spectrum Health Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured pre-operatively, at 25-35 days post op and 80-100 days post op
Awards & highlights
Study Summary
This trial compares two types of stomach surgery to see which one will help patients with stomach blockage eat solid food better.
Who is the study for?
This trial is for adults (≥18 years) with malignant gastric outlet obstruction, which causes symptoms like abdominal pain and vomiting. Participants must be able to undergo surgery under general anesthesia and have not had previous treatments for this condition. They should consent to study procedures and be available throughout the study.Check my eligibility
What is being tested?
The study compares two surgeries: Roux-en-Y Gastric Bypass versus Loop Gastrojejunostomy, to see which one is better at improving solid food intake within the first month after surgery in patients with malignant gastric outlet obstruction.See study design
What are the potential side effects?
Potential side effects of these surgeries may include infection, bleeding, reaction to anesthesia, nutritional deficiencies due to altered digestion, leakage from surgical connections between intestines or stomach.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured pre-operatively, at 25-35 days post op and 80-100 days post op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured pre-operatively, at 25-35 days post op and 80-100 days post op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Gastric emptying as per gastric emptying scintigraphy at 7 days post-operatively.
Secondary outcome measures
Gastric emptying study at 30-days
Improvement of quality of life as measured GIQLI
Improvement of quality of life as measured by short form QOL Questionnaire
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Roux-en-Y BypassExperimental Treatment1 Intervention
laparoscopic Roux-en-Y (R-Y) procedure is a well-established procedure, commonly utilized in the setting of bariatric- and gastric cancer surgery. The procedure establishes intestinal continuity that bypasses the distal stomach and duodenum. This is achieved by dividing the jejunum 30-40 cm distal to the ligament of Treitz, bringing the distal end of jejunum up anterior to the transverse colon to be anastomosed to the back wall of the stomach (forming the Roux-limb). The proximal cut end of jejunum then gets anastomosed to the downstream roux-limb (forming the Y-limb). The benefits of this reconstruction include less chance of gastric contents travelling into the afferent limb and similarly, avoiding bile reflux from the afferent limb with associated bile gastritis.
Group II: GastrojejunostomyExperimental Treatment1 Intervention
surgical gastrojejunostomy, a procedure dating back to the late 1800's.5 This surgical bypass consists of connecting the stomach to a loop of proximal small bowel, thus bypassing any duodenal or distal gastric obstruction.
Find a Location
Who is running the clinical trial?
Spectrum Health HospitalsLead Sponsor
64 Previous Clinical Trials
553,193 Total Patients Enrolled
G. Paul Wright, MDPrincipal InvestigatorCorewell Health
1 Previous Clinical Trials
15 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor presently open to participants?
"According to the latest updates hosted on clinicaltrials.gov, this trial is recruiting participants. It was first posted August 17th 2023 and information has been updated as of September 26th 2023."
Answered by AI
What is the sample size of this experiment?
"Indeed, the information posted on clinicaltrials.gov confirms that this trial is actively recruiting subjects. It was initially published on August 17th 2023 and recently updated on September 26th 2023. This medical experiment seeks to involve 16 individuals at a single site."
Answered by AI
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