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

NCT03701919 | Completed Phase 4 FDA Drug

• 1 other identifier: 5090
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Use of rescue antiemetics

  We will sum the number of "as needed" doses of intravenous antiemetics required by patients in both the treatment arm and the control arm of the study

  During inpatient hospitalization only, an average of 2-3 days

Secondary Outcomes (5)

• Patient satisfaction survey

  2 weeks postoperative

• Subjective experience of nausea

  2 weeks postoperative

• Number of episodes of vomiting

  2 weeks postoperative

• 30 day readmission rate

  30 days postoperative

• Hospital length of stay

  During inpatient hospitalization only, an average of 2-3 days

Study Arms (2)

Botulinum toxin pyloroplasty

EXPERIMENTAL

Intraoperative laparoscopic intramuscular injection of 100units (10cc) of Botulinum toxin into the pylorus

Drug: Botulinum toxin pyloroplasty

Normal saline pyloric injection

PLACEBO COMPARATOR

Intraoperative laparoscopic intramuscular injection of 10cc normal saline into the pylorus

Drug: Normal saline pyloric injection

Interventions

Botulinum toxin pyloroplasty DRUG

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

Also known as: Botox pyloropasty, Botulinum toxin A pyloroplasty

Botulinum toxin pyloroplasty

Normal saline pyloric injection DRUG

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

Normal saline pyloric injection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective sleeve gastrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Medical College: lead
• Allergan: collaborator

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Jessica Zaman, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 10, 2018
• Study Start: January 7, 2019
• Primary Completion: November 11, 2022
• Study Completion: November 11, 2022
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)