Botulinum Toxin Pyloroplasty to Reduce Postoperative Nausea and Vomiting After Sleeve Gastrectomy
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 1/12/2019 |
| Start Date: | January 7, 2019 |
| End Date: | April 1, 2020 |
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.
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.
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.
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.
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
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