- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03199352
Hand-sewn and Linear-stapled Roux-en-Y Gastric Bypass: Outcomes
Comparison of Hand-sewn and Linear-stapled Roux-en-Y Gastric Bypass: Outcomes in Stricture, Ulceration, and Gastritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
1. Screening and Informed Consent Subjects will be screened on a weekly basis for eligibility of enrollment. If eligible, patients will be approached by study staff at the initial surgical consultation. The purpose of the study and risks of the procedures will be explained to the subject and the consent process must be documented accordingly in the medical record. Subjects who agree to study participation must sign an IRB approved informed consent form. Subjects will be informed that their participation in this study is voluntary and they may refuse to participate or discontinue from the study at any time. Subjects will be given the opportunity to ask the investigator questions so that they are adequately informed about the research. A copy of the signed informed consent must be provided to the subject and the informed consent process will be documented in source documents. If new information becomes available that may affect a subject's decision to continue to take part in the study, this information will be discussed with the subject by the investigator.
Failure to meet submission requirements:
Each patient will be required to meet their individual insurance companies requirements for submission of bariatric surgery approval. Subjects who provide study consent but then do not submit for insurance approval or are denied will be considered "discontinued" and will not require additional study follow-up visits. The reason for the discontinuation will be clearly delineated on the applicable case report form. Subjects in whom the robotic RYGB procedure is begun but not completed will be considered "discontinued" once discharged from the hospital and not require any additional study follow-up visits. Reasons for discontinuation will be recorded in the case report form. Additionally, female patients of child bearing age will undergo a standard of care pregnancy test at the time of the pre-operative surgical testing (2/3 weeks before surgery) and always the morning of surgery by urine HCG.
Surgical Procedures:
The operation will be performed per standard of care for both the laparoscopic RYGB and the robotic RYGB. The main difference between the two procedures is that in the robotic procedure, the intestinal anastomosis will be hand-sewn and in the laparoscopic RYGB, the anastomosis will be performed using a linear staple. Subjects will be maintained on a low-calorie diet for the first post-operative month, as per standard of care. In addition, multivitamin supplements, calcium, and iron should be prescribed and maintained per standard of care.
Schedule:
Subjects will be evaluated preoperatively, during the procedure, at discharge, and at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months. Assessments to be conducted/data collected at each visit are listed below and in the study assessments table.
Pre-operative Assessment
The following assessments will be performed pre-operatively prior to the scheduled surgical procedure and the results recorded on the appropriate subject report form:
Verification of pre-operative eligibility criteria Subject demographics (gender, age, race, ethnicity, smoking history) Height, weight, and body mass index (BMI) Comorbidity assessment (prevalence and duration of type 2 diabetes mellitus, sleep apnea, hypertension, dyslipidemia/hyperlipidemia, and other clinically relevant comorbidities as determined by the treating physician), including medications Fasting labs (glucose, hemoglobin, HbA1C, hematocrit, ferritin, albumin, total protein, calcium, parathyroid hormone, vitamin A, Vitamin B1, Vitamin B12, Vitamin D2/3, Vitamin 3, Vitamin K, folic acid, insulin, lipid panel, triglycerides, total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), C-peptides, iron, copper, and zinc) Surgical history Health- related Quality of life, as measured by the SF-36 assessment Gastrointestinal symptom rating scale, as measured by the GSRS form GERD HR-QL Pre-operative Dietary Restrictions
- Operative Assessment The following procedures and assessments will be performed on the day of/during the procedure: Weight and BMI American Society of Anesthesiologists (ASA) grade operative time (defined as skin to skin time) anesthesia start and stop time estimated blood loss adverse events surgical technique surgical conversions to open concomitant procedures performed during the procedure
Discharge Assessment
The following procedures and assessments will be performed prior to discharge:
Length of hospital stay Surgical site infection assessment Surgical site infection (SSI) Adverse events (see below)
Post-operative follow-up assessments
The following procedures and assessments will be performed at 2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months post procedure (+/- 7 days for 2 and 6 week follow-up, +/- 14 day days for all other months).
Post-operative standard of care:
Compliance with prescribed dietary supplements Weight and BMI EWL Comorbidity assessment (prevalence and duration of type 2 diabetes mellitus, sleep apnea, hypertension, dyslipidemia/hyperlipidemia, and other clinically relevant comorbidities as determined by the treating physician), including medications and relevant lab tests per standard of care at 3, 6, and 12 months (glucose, hemoglobin, HbA1C, hematocrit, ferritin, albumin, total protein, calcium, parathyroid hormone, vitamin A, Vitamin B1, Vitamin B12, Vitamin D2/3, Vitamin 3, Vitamin K, folic acid, insulin, lipid panel, triglycerides, total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), C-peptides, iron, copper, and zinc) Surgical site infection assessment at 1 month only health-related quality of life (HR-QOL) (SF-36), GERD-HRQL and GSRS questionnaire expressed as change from baseline at 3, 6 and 12 months only EGD at 1 year to assess stricture, marginal ulceration, and gastritis adverse events (see below)
- Adverse Events Adverse events for all bariatric procedures are tracked within our centers Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database. All bariatric centers accredited by the American Society for Metabolic and Bariatric Surgery (ASMBS) are required to submit all bariatric surgery data to the MBSAQIP database for quality review. Our bariatric surgery team has open access to our centers data for quality review purposes and will compare adverse events for the robotic and laparoscopic RYGB to the other procedures performed by our center. Adverse events are categorized by organ system (wound, respiratory, urinary tract, CNS, cardiac, or other) as specified by the MBSAQIP. Any post-operative occurrence within 30 days will be documented if related to the bariatric procedure. Bariatric related readmission and reoperations are also tracked per MBSAQIP guidelines.
Study Type
Contacts and Locations
Study Locations
-
-
Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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Omaha, Nebraska, United States, 986245
- University of Nebraska Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Men and women age 19-70 who will receive their weight loss procedure at UNMC
- BMI of 35-45
- RYGB as the primary procedure
Exclusion Criteria:
- RYGB performed as a revisional procedure
- Prior foregut surgery
- H/o smoking, unless the patient quit more than 10 years ago
- Complication of bariatric procedure post-operatively that would significantly affect weight loss (extended period of TPN, clinically significant leak, major organ failure, severe protein malnutrition or failure to thrive)
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
RYGB: Hand-sewn
This group would receive a Roux-en-y gastric bypass with the anastomosis hand-sewn using a minimally-invasive robotic surgical approach
|
Patients will have the RYGB anastomosis hand-sewn
|
RYGB: linear-staple
This group would receive a Roux-en-y gastric bypass with the anastomosis sewn with a linear stapler using a laparoscopic surgical approach
|
Patients will have the RYGB anastomosis performed using a linear staple.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stricture Rate
Time Frame: 1 year
|
Examine the development of stricture at the anastomosis.
Stricture will be determined by esophagogastroduodenoscopy (EGD) at 1 year post-surgery.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Leak rate
Time Frame: 1 year
|
Examine leak development at the anastomosis site.
Leak is determined by clinical findings of pain, tachycardia, fever, and confirmed by a barium swallow study that indicates a hole at the anastomosis site
|
1 year
|
Quality of Life impact
Time Frame: 1 year
|
Examine the quality of life impact of the surgery, using the SF-36 questionnaire
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vishal Kothari, MD, University of Nebraska
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0280-17-FB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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