Botulinum Toxin Pyloroplasty to Reduce Postoperative Nausea and Vomiting After Sleeve Gastrectomy

• Status: Unknown status
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

Summary

A common problem following sleeve gastrectomy surgery is called postoperative nausea and vomiting (PONV). This problem is uncomfortable for patients, and can also lead to other complications, including pneumonia. It is unclear what exactly causes this problem, but it may be partly caused by slow emptying of the stomach. The current treatments for PONV include medications, but these may only treat the symptoms. Botulinum toxin (BTX, brand name Botox®), produced naturally by the bacterium Clostridium botulinum and adapted for medical use, is an neurotransmitter inhibitor of the neuromuscular junction, and produces temporary muscular paralysis. BTX is widely used in cosmetic and other medical applications. Injecting BTX into the pylorus, which is the circular sphincter muscle at the end of the stomach, temporarily paralyzes the muscle, leaving it wide open, and allowing stomach contents to flow through. This effect lasts for several weeks, and then goes away. This may help prevent PONV.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albany Medical College
• Collaborator: Allergan
• Treatments: Botulinum Toxins; Botulinum Toxins, Type A

Criteria

Inclusion criteria:

• Patients undergoing elective sleeve gastrectomy

Exclusion criteria:

• Prior gastric surgery resulting in altered anatomy

• Documented history of postoperative nausea or vomiting

• Allergy to any of the medications used in the study

• Any use of Botulinum toxin products within six months prior to study enrollment, or plans to use Botulinum toxin products during study enrollment