Sleeve GastrectomyNCT04168060
Crural Dissection in Sleeve Gastrectomy
A study testing Crura dissection, Sleeve gastrectomy and Hiatal hernia repair in people with Sleeve Gastrectomy, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to identify if there is a benefit in routine dissection of the diaphragmatic crura during sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Sleeve Gastrectomy
- What is being tested?
- Crura dissection, Sleeve gastrectomy and Hiatal hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2019to 28 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing primary sleeve gastrectomy at the University of Miami Division of Bariatric surgery
- Age between 18-69 years
- Able to provide consent
Who cannot join
- History of anti-reflux procedure
- History of foregut surgery
- Narcotic dependence
- History of gastroparesis
- Special/vulnerable populations such as minors, patients unable to consent, pregnant women, and prisoners will not be included in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Medical Campus
Miami, Florida, 33136
About this study
Official title: The Effect of Routine Crura Dissection in Sleeve Gastrectomy on Post-Operative Symptoms
The purpose of this study is to identify if there is a benefit in routine dissection of the diaphragmatic crura during sleeve gastrectomy.
- Conditions
- Sleeve Gastrectomy
- Being tested
- Crura dissection, Sleeve gastrectomy, Hiatal hernia repair
- Keywords
- sleeve gastrectomy, crura dissection, bariatric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crura dissectionProcedure or surgery
The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy.
Sleeve gastrectomyProcedure or surgery
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.
Hiatal hernia repairProcedure or surgery
This involves tightening the opening in your diaphragm with stitches to keep your stomach from bulging upward through the opening in the muscle wall.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Crura dissection; Procedure: Sleeve gastrectomy; Procedure: Hiatal hernia repair |
| 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. Receives: Procedure: Sleeve gastrectomy |
| 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. Receives: Procedure: Crura dissection; Procedure: Sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 months
Secondary outcomes (1)
Correlation of the presence of hiatal hernias
Correlation of the presence of hiatal hernias between pre-operative upper Gastrointestinal (GI) series and surgical findings.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start22 Nov 2019
- Primary completion28 May 2025
- Study completion28 May 2025
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleeve GastrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nestor De La Cruz-Munoz, University of Miami
- Investigators
- Nestor De La Cruz-Munoz, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168060
- Sponsor's protocol ID
- 20190190
- Status last verified
- May 2025
- First submitted
- 15 Nov 2019
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Routine Crura Dissection in Sleeve Gastrectomy on Post-Operative Symptoms
- ClinicalTrials.gov ID
- NCT04168060
- Acronym / sponsor ID
- 20190190
- Conditions
- Sleeve Gastrectomy
- Keywords
- sleeve gastrectomy, crura dissection, bariatric surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify if there is a benefit in routine dissection of the diaphragmatic crura during sleeve gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crura Dissection | Experimental | Procedure: Crura dissection, Procedure: Sleeve gastrectomy, Procedure: Hiatal hernia repairParticipants with a visually detectable hiatal hernia at the time of sleeve gastrectomy procedure will undergo a crura dissection and hiatal hernia repair. |
| National Practice | Experimental | Procedure: Sleeve gastrectomyParticipants 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. |
| Standard of Care | Experimental | Procedure: Crura dissection, Procedure: Sleeve gastrectomyParticipants 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients undergoing primary sleeve gastrectomy at the University of Miami Division of Bariatric surgery
- Age between 18-69 years
- Able to provide consent
Key exclusion criteria (5 listed)
- History of anti-reflux procedure
- History of foregut surgery
- Narcotic dependence
- History of gastroparesis
- Special/vulnerable populations such as minors, patients unable to consent, pregnant women, and prisoners will not be included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crura dissectionThe diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy. | Procedure or surgery | Crura Dissection, Standard of Care |
| Sleeve gastrectomySurgical 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 or surgery | Crura Dissection, National Practice, Standard of Care |
| Hiatal hernia repairThis involves tightening the opening in your diaphragm with stitches to keep your stomach from bulging upward through the opening in the muscle wall. | Procedure or surgery | Crura Dissection |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Correlation of the presence of hiatal hernias
Time frame: Day 1
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nestor De La Cruz-Munoz, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crura dissection, Sleeve gastrectomy and Hiatal hernia repair in people with Sleeve Gastrectomy, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.