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

250 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Crural Dissection for Sleeve Gastrectomy?

Research shows that sleeve gastrectomy, a key part of this treatment, is effective for significant weight loss and improvement in health conditions related to obesity. It is widely used and studied for its benefits in treating severe obesity. ^{1 2 3 4 5}

Is crural dissection for sleeve gastrectomy generally safe for humans?

Sleeve gastrectomy is generally considered safe, but it does have some risks, such as gastric leaks and staple line issues, which are important to be aware of. ^{6 7 8 9 10}

How is sleeve gastrectomy different from other treatments for obesity?

Sleeve gastrectomy is unique because it involves removing a large portion of the stomach to create a tube-like structure, which limits food intake and reduces hunger. This procedure is minimally invasive and can include techniques like staple-line reinforcement to prevent complications such as bleeding. Unlike other weight loss surgeries, it does not involve rerouting the intestines. ^{11 12 13 14 15}

Research Team

Nestor De La Cruz-Munoz, MD

Principal Investigator

University of Miami

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of sleeve gastrectomy as sole procedure in patients with clinically severe obesity (BMI ≤50 kg/m(2)). [2022]

2. England pubmed.ncbi.nlm.nih.gov

Complications and nutrient deficiencies two years after sleeve gastrectomy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Management Options for Twisted Gastric Tube after Laparoscopic Sleeve Gastrectomy. [2018]

4. Turkey pubmed.ncbi.nlm.nih.gov

Nutritional Deficiencies in Morbid Obese Patients Before and After Laparoscopic Sleeve Gastrectomy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Is sleeve gastrectomy a therapeutic procedure for all obese patients? [2019]

6. Spain pubmed.ncbi.nlm.nih.gov

Sleeve gastrectomy as a surgical technique in bariatric surgery: Results of safety and effectiveness. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

Sleeve gastrectomy as a surgical technique in bariatric surgery: Results of safety and effectiveness. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Blind nasogastric tube advancement following sleeve gastrectomy: an animal model. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Comparative Safety of Sleeve Gastrectomy and Gastric Bypass: An Instrumental Variables Approach. [2022]

10. Brazil pubmed.ncbi.nlm.nih.gov

THE ROUTINE USE OF THE METHYLENE BLUE TEST IN SLEEVE GASTRECTOMY: WHY NOT? [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Sleeve-forming gastrectomy is the right terminology. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Comparative Study of Performance in Ultrasonic Tissue Dissection for Sleeve Gastrectomy: Wired versus Cordless. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

Staple-line reinforcement with a thrombin matrix during laparoscopic sleeve gastrectomy for morbid obesity: a case series. [2012]

14. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic Sleeve Gastrectomy With or Without Staple Line Inversion and Distal Fixation to the Transverse Mesocolon: Impact on Early Postoperative Outcomes. [2018]

15. Germany pubmed.ncbi.nlm.nih.gov

Identification of technical errors and hazard zones in sleeve gastrectomy using OCHRA : "OCHRA for sleeve gastrectomy". [2019]