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

NCT03701919 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-04-10

No results posted yet for this study

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.

Conditions

  • Bariatric Surgery
  • Postoperative Nausea and Vomiting

Interventions

DRUG

Botulinum toxin pyloroplasty

Intraoperative laparoscopic injection of Botulinum toxin into the pylorus immediately following sleeve gastrectomy

DRUG

Normal saline pyloric injection

Intraoperative laparoscopic injection of normal saline into the pylorus immediately following sleeve gastrectomy

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Albany Medical College

    lead OTHER

Principal Investigators

  • Jessica Zaman, MD · Albany Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2022-11-11
Completion
2022-11-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03701919 on ClinicalTrials.gov