An interventional study of Crura dissection and Sleeve gastrectomy in Sleeve Gastrectomy, sponsored by University of Miami. Terminated at 1 site in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
The purpose of this study is to identify if there is a benefit in routine dissection of the diaphragmatic crura during sleeve gastrectomy.
University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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 · Procedure: Sleeve gastrectomy · Procedure: Hiatal hernia repair
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
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 · Procedure: Sleeve gastrectomy
The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic 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.
This involves tightening the opening in your diaphragm with stitches to keep your stomach from bulging upward through the opening in the muscle wall.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 months
Correlation of the presence of hiatal hernias
Correlation of the presence of hiatal hernias between pre-operative upper Gastrointestinal (GI) series and surgical findings.
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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