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Crura Dissection in Sleeve Gastrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04168060
Recruitment Status : Enrolling by invitation
First Posted : November 19, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Nestor De La Cruz-Munoz, University of Miami

Brief Summary:
The purpose of this study is to identify if there is a benefit in routine dissection of the diaphragmatic crura during sleeve gastrectomy.

Condition or disease Intervention/treatment Phase
Sleeve Gastrectomy Procedure: Crura dissection Procedure: Sleeve gastrectomy Procedure: Hiatal hernia repair Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Routine Crura Dissection in Sleeve Gastrectomy on Post-Operative Symptoms
Actual Study Start Date : November 22, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Crura Dissection
Participants with a visually detectable hiatal hernia at the time of sleeve gastrectomy procedure will undergo a crura dissection and hiatal hernia repair.
Procedure: Crura dissection
The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy.

Procedure: Sleeve gastrectomy
Surgical weight-loss procedure in which the stomach is reduced to about 15% of its original size, by surgical removal of a large portion of the stomach along the greater curvature.

Procedure: Hiatal hernia repair
This involves tightening the opening in your diaphragm with stitches to keep your stomach from bulging upward through the opening in the muscle wall.

Experimental: National Practice
Participants with no detectable hiatal hernia will be randomized to either Group 2 or 3. Group 2 participants will be treated to the national practice patterns of complete dissection of the curvature of the stomach without dissection of the crura.
Procedure: Sleeve gastrectomy
Surgical weight-loss procedure in which the stomach is reduced to about 15% of its original size, by surgical removal of a large portion of the stomach along the greater curvature.

Experimental: Standard of Care
Participants with no detectable hiatal hernia will be randomized to either Group 2 or 3. Group 3 participants will undergo the institutional standard of care with the dissection of the crura.
Procedure: Crura dissection
The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy.

Procedure: Sleeve gastrectomy
Surgical weight-loss procedure in which the stomach is reduced to about 15% of its original size, by surgical removal of a large portion of the stomach along the greater curvature.




Primary Outcome Measures :
  1. Change in Perioperative Symptoms as assessed by the Intermediate and Late-Post Operative Pain, Nausea and Dysphagia Questionnaire [ Time Frame: Day 1, 12 months ]
    The Intermediate and Late Post-Operative Pain, Nausea and Dysphagia Questionnaire is a 7-item questionnaire with scores ranging 0-40 with the higher score indicating severe symptoms.

  2. Change in Perioperative Symptoms as assessed by the Rhodes Index of Nausea, Vomiting and Retching Questionnaire [ Time Frame: Day 1, 12 months ]
    The Rhodes Index of Nausea, Vomiting and Retching Questionnaire is an 8-item questionnaire with scores ranging from 0 to 32 with a higher score indicating increased symptoms of nausea.

  3. Change in Perioperative Symptoms as assessed by the Gastroesophageal Reflux Disease-Questionnaire (GERD-Q) [ Time Frame: Baseline, 12 months ]
    The GERD-Q has a scoring range between 0-18 with a higher score indicating increased likelihood of GERD.

  4. Change in Perioperative Symptoms as assessed by the Brief Esophageal Dysphagia Questionnaire (BEDQ) [ Time Frame: Baseline, 12 months ]
    The BEDQ has a scoring range between 0-40 with a higher score indicating increased symptoms of dysphagia.


Secondary Outcome Measures :
  1. Correlation of the presence of hiatal hernias [ Time Frame: Day 1 ]
    Correlation of the presence of hiatal hernias between pre-operative upper Gastrointestinal (GI) series and surgical findings.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. All patients undergoing primary sleeve gastrectomy at the University of Miami Division of Bariatric surgery
  2. Age between 18-69 years
  3. Able to provide consent

Exclusion criteria:

  1. History of anti-reflux procedure
  2. History of foregut surgery
  3. Narcotic dependence
  4. History of gastroparesis
  5. Special/vulnerable populations such as minors, patients unable to consent, pregnant women, and prisoners will not be included in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04168060


Locations
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United States, Florida
University of Miami Medical Campus
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Nestor De La Cruz-Munoz, MD University of Miami

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Responsible Party: Nestor De La Cruz-Munoz, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04168060    
Other Study ID Numbers: 20190190
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nestor De La Cruz-Munoz, University of Miami:
sleeve gastrectomy
crura dissection
bariatric surgery