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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

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.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Postoperative Nausea and Vomiting Drug: Botulinum toxin pyloroplasty Drug: Normal saline pyloric injection Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Pyloroplasty to Reduce Postoperative Nausea and Vomiting After Sleeve Gastrectomy
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Botulinum toxin pyloroplasty
Intraoperative laparoscopic intramuscular injection of 100units (10cc) of Botulinum toxin into the pylorus
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

Placebo Comparator: Normal saline pyloric injection
Intraoperative laparoscopic intramuscular injection of 10cc normal saline into the pylorus
Drug: Normal saline pyloric injection
Intraoperative laparoscopic injection of normal saline into the pylorus immediately following sleeve gastrectomy




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Patient satisfaction survey [ Time Frame: 2 weeks postoperative ]
    Likert scales describing overall satisfaction with postoperative course

  2. Subjective experience of nausea [ Time Frame: 2 weeks postoperative ]
    Likert score rating subjective experience of nausea

  3. Number of episodes of vomiting [ Time Frame: 2 weeks postoperative ]
    Number of episodes of emesis

  4. 30 day readmission rate [ Time Frame: 30 days postoperative ]
    30 day readmission rate

  5. Hospital length of stay [ Time Frame: During inpatient hospitalization only, an average of 2-3 days ]
    Hospital length of stay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701919


Locations
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United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Sponsors and Collaborators
Albany Medical College
Allergan
Investigators
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Principal Investigator: Jessica Zaman, MD Albany Medical College
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Responsible Party: Jessica Zaman, Assistant Professor of Surgery, Albany Medical College
ClinicalTrials.gov Identifier: NCT03701919    
Other Study ID Numbers: 5090
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs