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Changes in practice patterns. From COVID-related disruptions to the adoption of ERAS protocols and robotic surgery, there was significant variability in standards of care making direct comparison between groups impractical.
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The purpose of this study is to identify if there is a benefit in routine dissection of the diaphragmatic crura during sleeve gastrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crura Dissection | Experimental | Participants with a visually detectable hiatal hernia at the time of sleeve gastrectomy procedure will undergo a crura dissection and hiatal hernia repair. |
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| National Practice | Experimental | 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. |
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| Standard of Care | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crura dissection | Procedure | The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Perioperative Symptoms as assessed by the Intermediate and Late-Post Operative Pain, Nausea and Dysphagia Questionnaire | 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. | Day 1, 12 months |
| Change in Perioperative Symptoms as assessed by the Rhodes Index of Nausea, Vomiting and Retching Questionnaire | 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. | Day 1, 12 months |
| Change in Perioperative Symptoms as assessed by the Gastroesophageal Reflux Disease-Questionnaire (GERD-Q) | The GERD-Q has a scoring range between 0-18 with a higher score indicating increased likelihood of GERD. | Baseline, 12 months |
| Change in Perioperative Symptoms as assessed by the Brief Esophageal Dysphagia Questionnaire (BEDQ) | The BEDQ has a scoring range between 0-40 with a higher score indicating increased symptoms of dysphagia. | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of the presence of hiatal hernias | Correlation of the presence of hiatal hernias between pre-operative upper Gastrointestinal (GI) series and surgical findings. | Day 1 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nestor De La Cruz-Munoz, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Medical Campus | Miami | Florida | 33136 | United States |
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| Sleeve gastrectomy | Procedure | 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. |
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| Hiatal hernia repair | Procedure | This involves tightening the opening in your diaphragm with stitches to keep your stomach from bulging upward through the opening in the muscle wall. |
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