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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03701919
Recruitment Status : Enrolling by invitation
First Posted : October 10, 2018
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Jessica Zaman, Albany Medical College

Tracking Information
First Submitted Date  ICMJE October 1, 2018
First Posted Date  ICMJE October 10, 2018
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE January 7, 2019
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
Use of rescue antiemetics [ Time Frame: During inpatient hospitalization only, an average of 2-3 days ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
  • Patient satisfaction survey [ Time Frame: 2 weeks postoperative ]
    Likert scales describing overall satisfaction with postoperative course
  • Subjective experience of nausea [ Time Frame: 2 weeks postoperative ]
    Likert score rating subjective experience of nausea
  • Number of episodes of vomiting [ Time Frame: 2 weeks postoperative ]
    Number of episodes of emesis
  • 30 day readmission rate [ Time Frame: 30 days postoperative ]
    30 day readmission rate
  • Hospital length of stay [ Time Frame: During inpatient hospitalization only, an average of 2-3 days ]
    Hospital length of stay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botulinum Toxin Pyloroplasty to Reduce Postoperative Nausea and Vomiting After Sleeve Gastrectomy
Official Title  ICMJE Botulinum Toxin Pyloroplasty to Reduce Postoperative Nausea and Vomiting After Sleeve Gastrectomy
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.
Detailed Description

Postoperative nausea and vomiting (PONV) remains a common complaint after bariatric surgery such as the sleeve gastrectomy, where the prevalence is estimated to be as high as 60-80%. PONV is frequently of greater concern to patients than postoperative pain, decreasing patient satisfaction and the perioperative experience. In addition, PONV increases the risk for aspiration, dehydration, electrolyte abnormalities, incisional dehiscence, esophageal injury, and other adverse events. Finally, PONV delays postoperative diet resumption and increases hospital length of stay. Numerous medication regimens have been tried to reduce PONV after sleeve gastrectomy, with varying success. A procedure called Botulinum toxin pyloroplasty (BP), which involves injection of botulinum toxin into the muscular sphincter at the end of the stomach, called the pylorus, has been demonstrated to improve gastric emptying. The investigators hypothesize that intraoperative BP during sleeve gastrectomy will decrease rates of PONV.

Botulinum toxin type A (Botox®), produced naturally by the bacterium Clostridium botulinum and adapted for medical use, is an inhibitor of the neurotransmitter acetylcholine at the neuromuscular junction, producing flaccid muscular paralysis. The effects of Botox® injection are temporary and reversible, and its duration of action ranges from weeks to months. Botox® injection has been widely used in many contexts, most familiarly during office-based cosmetic procedures and also in disorders such as torticollis, spasticity, hyperhidrosis, bladder overreactivity, and dystonias. It has been used endoscopically to relieve achalasia and dysphagia by injection into the lower esophageal sphincter. Gastroenterologists have reported successful treatment of gastroparesis using BP, by relieving the tonic contraction of the pylorus and increasing gastric transit time. Postoperative endoscopic BP has been utilized to improve gastroparesis following gastrectomy. The use of BP during bariatric surgery has not been reported. This proposal represents the first study to evaluate the use of intraoperative BP to decrease PONV after sleeve gastrectomy.

This technique involves pyloroplasty following completion of the robot-assisted laparoscopic sleeve gastrectomy. The investigators mix 100 units of Botox® powder in 10ml of saline. Using the robot, the investigators inject the pylorus laparoscopically using an 18-gauge, 0.5-inch laparoscopic needle. Meanwhile, an assistant surgeon intubates the stomach with an endoscope, which the investigators use to assess the gastric staple line and perform a leak test. Prior to injection of Botox® into the pylorus, the investigators confirm endoscopically that the tip of the needle is not intraluminal. After first aspirating to ensure the needle is intramuscular and free from any vascular structures, the investigators then inject the pylorus with approximately 5ml of Botox®. Proper placement of the injection is confirmed by visualizing a rising weal. The anterior, superior, and inferior aspects of the pylorus are injected with approximately 5-6 injections of 1ml each. The posterior aspect of the pylorus is not injected, since this is not readily accessible from a laparoscopic approach, and also contains the major vascular structure of the pylorus, the gastroduodenal artery.

This technique has been performed at Albany Medical Center institution more than 200 times over the past four years. The Albany Medical Center Bariatric Center as participated in the Metabolic and Bariatric Surgery Accreditation for 10 years, and so has collected comprehensive and granular data on complication rates and surgical outcomes. Analysis of this data demonstrates that enteric use of Botox® is safe.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bariatric Surgery
  • Postoperative Nausea and Vomiting
Intervention  ICMJE
  • Drug: Botulinum toxin pyloroplasty
    Intraoperative laparoscopic injection of Botulinum toxin into the pylorus immediately following sleeve gastrectomy
    Other Names:
    • Botox pyloropasty
    • Botulinum toxin A pyloroplasty
  • Drug: Normal saline pyloric injection
    Intraoperative laparoscopic injection of normal saline into the pylorus immediately following sleeve gastrectomy
Study Arms  ICMJE
  • Experimental: Botulinum toxin pyloroplasty
    Intraoperative laparoscopic intramuscular injection of 100units (10cc) of Botulinum toxin into the pylorus
    Intervention: Drug: Botulinum toxin pyloroplasty
  • Placebo Comparator: Normal saline pyloric injection
    Intraoperative laparoscopic intramuscular injection of 10cc normal saline into the pylorus
    Intervention: Drug: Normal saline pyloric injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 8, 2018)
104
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2020
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03701919
Other Study ID Numbers  ICMJE 5090
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jessica Zaman, Albany Medical College
Study Sponsor  ICMJE Albany Medical College
Collaborators  ICMJE Allergan
Investigators  ICMJE
Principal Investigator: Jessica Zaman, MD Albany Medical College
PRS Account Albany Medical College
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP