Crural Dissection for Sleeve Gastrectomy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Narcotics

Disqualifiers: Anti-reflux, Foregut surgery, Gastroparesis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Day 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if dissecting the diaphragmatic crura (a part of the diaphragm) during sleeve gastrectomy offers benefits. It includes three groups: one receives the standard sleeve gastrectomy with crura dissection, another follows national practice patterns without crura dissection, and the last group undergoes crura dissection only if a hiatal hernia is present. Individuals having their first sleeve gastrectomy, without a history of certain stomach surgeries or conditions, might be suitable candidates.

As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that crura dissection is safe for sleeve gastrectomy?

Research shows that sleeve gastrectomy, the surgery under study, is generally safe. However, some studies have found it can lead to long-term issues like acid reflux, where stomach acid often flows back into the esophagus.

For crura dissection and hiatal hernia repair, which are also under study, evidence suggests they are safe and effective. Studies have not shown any increase in death rates or longer hospital stays when combined with sleeve gastrectomy. No major negative outcomes have been reported, indicating these procedures are generally well-tolerated.

Safety information continues to update as more individuals undergo these procedures and further research emerges. This information can help prospective participants understand the safety of these procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different surgical techniques for sleeve gastrectomy, which is a common procedure for weight loss. Unlike the standard approach that typically involves complete dissection of the stomach's curvature, one arm of this trial investigates the impact of crura dissection, which is the separation and repair of the diaphragm muscle when a hiatal hernia is present. This could potentially improve outcomes by addressing hiatal hernias that might otherwise complicate the surgery. By comparing these methods, the trial aims to determine whether these variations in technique can lead to better patient outcomes, such as reduced complications or improved weight loss results.

What evidence suggests that this trial's treatments could be effective for sleeve gastrectomy?

Research has shown that sleeve gastrectomy, particularly when combined with specific surgical techniques to repair a hiatal hernia, can aid in weight loss and reduce acid reflux symptoms. In this trial, participants with a visually detectable hiatal hernia will undergo crura dissection and hiatal hernia repair during the sleeve gastrectomy procedure. One study found that patients who received this combined treatment experienced improvements in their body mass index (BMI) and symptoms of gastroesophageal reflux disease (GERD). Another study found that this approach helps reduce reflux and achieve weight loss goals. The success of sleeve gastrectomy with these techniques relies on using the right methods and selecting the right patients. Overall, these treatments appear promising for individuals struggling with weight and reflux issues. ^{2 4 6 7 8}

Who Is on the Research Team?

Nestor De La Cruz-Munoz, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 18-69 planning to undergo primary sleeve gastrectomy at the University of Miami's Bariatric surgery division. It excludes those with a history of anti-reflux procedures, foregut surgeries, gastroparesis, narcotic dependence, and vulnerable groups unable to consent.

Inclusion Criteria

I am having a sleeve gastrectomy at the University of Miami.

Able to provide consent

Exclusion Criteria

I have had surgery to prevent acid reflux.

You are addicted to narcotics.

Special/vulnerable populations such as minors, patients unable to consent, pregnant women, and prisoners will not be included in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo sleeve gastrectomy with or without crura dissection based on randomization

Day 1

1 visit (in-person)

Follow-up

Participants are monitored for changes in perioperative symptoms using various questionnaires

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Crura dissection
• Hiatal hernia repair
• Sleeve gastrectomy

Trial Overview The study aims to determine if routinely dissecting the diaphragmatic crura during a sleeve gastrectomy (a weight-loss surgery) offers any benefits. This includes patients who may also require hiatal hernia repair.

How Is the Trial Designed?

Group I: Standard of Care Experimental Treatment 2 Interventions

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.

Group II: National Practice Experimental Treatment 1 Intervention

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.

Group III: Crura Dissection Experimental Treatment 3 Interventions

Participants with a visually detectable hiatal hernia at the time of sleeve gastrectomy procedure will undergo a crura dissection and hiatal hernia repair.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

In a study of 1136 patients who underwent sleeve gastrectomy, the methylene blue test (MBT) demonstrated high specificity (98%) and negative predictive value (99%), making it a reliable method to rule out postoperative leaks.

Despite its high specificity, MBT had low sensitivity (22%) and only identified 2 out of 9 actual leaks, indicating that while it is effective for ruling out leaks, it may not be sufficient for confirming their presence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

THE ROUTINE USE OF THE METHYLENE BLUE TEST IN SLEEVE GASTRECTOMY: WHY NOT? Ferraz, ÁAB., Santa-Cruz, F., Belfort, JV., et al.[2022]

In a study of 38,153 bariatric surgery patients, sleeve gastrectomy was associated with fewer re-interventions (9.9% vs. 15.6%) and complications (6.6% vs. 9.6%) compared to gastric bypass after 2 years, indicating a better safety profile for sleeve gastrectomy.

Despite its overall safety advantages, sleeve gastrectomy had a slightly higher rate of revisions (0.6% vs. 0.4%) compared to gastric bypass, suggesting that while it is safer, the risk of needing further surgery should be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Safety of Sleeve Gastrectomy and Gastric Bypass: An Instrumental Variables Approach. Chhabra, KR., Telem, DA., Chao, GF., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12003324/

Comparing the clinical outcomes of laparoscopic sleeve ... Our research with short-term results reports similar improvement in BMI and GERD symptoms in patients with LSG and HHR with or without LNF.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X23017146

Long-Term Results After Laparoscopic Sleeve Gastrectomy ... Accurate patient selection and proper sleeve technique, combined with posterior cruroplasty (simple or reinforced) ensure effectiveness, with a rate of failure ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04168060

NCT04168060 | Crural Dissection in Sleeve Gastrectomy An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4. mdpi.com mdpi.com/2077-0383/12/9/3323

Efficacy of Sleeve Gastrectomy with Concomitant Hiatal ... This study revealed that both SG with concomitant HHR and sleeve–fundoplication are effective in terms of reflux resolution and weight outcomes.

5. ddw.digitellinc.com ddw.digitellinc.com/p/s/effect-of-hiatal-hernia-repair-on-gastroesophageal-reflux-symptoms-after-sleeve-gastrectomy-a-prospective-observational-study-4162

EFFECT OF HIATAL HERNIA REPAIR ON ... Introduction: An estimated 30% of patients may develop de-novo or worsen pre-existing gastroesophageal reflux disease (GERD) after Sleeve Gastrectomy (LSG).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10687114/

Outcomes of Concurrent Hiatus Hernia Repair with ... Among LAGB studies, all 4 studies were concluded to be safe and effective with no adverse outcomes on mortality and length of stay. GORD rates ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7732366/

Concomitant Hiatal Hernia Repair with Sleeve Gastrectomy The NSQIP data from 2010-2014 showed a rate of 14%, this increased to 21% in the 2015 MBSAQIP data and in our data spanning 2013-17, it increased further to 24% ...

8. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2025.1513695/full

Comparing the clinical outcomes of laparoscopic sleeve ... Conclusion: Our research with short-term results reports similar improvement in BMI and GERD symptoms in patients with LSG and HHR with or ...