Laparoscopic Pyloromyotomy George W. Holcomb, III, M.D., MBA Children’s Mercy Hospital Kansas City, Missouri

Preoperative Evaluation Pyloric Stenosis Non-bilious emesis 2-8 wks of age Male:Female 4:1 Dehydration/Metabolic Alkalosis Jaundice 10% Ultrasound - length - > 14 mm thickness - > 4 mm

Indications for Surgery Presence of pyloric stenosis Need to correct electrolyte abnormalities and dehydration

Patient Positioning Baby placed across operating table Table tilted toward surgeon Monitor in front of surgeon Assistant/camera holder to right of surgeon Scrub nurse opposite assistant Red rubber catheter in stomach

Equipment 5 mm umbilical cannula – 4 mm, 70o telescope Arthroscopy knife (Linvatec) Pyloric spreader Atraumatic grasping forcep

Tips and Tricks Set knife at 2 mm depth Incise serosa and muscle to 2 mm Sheath knife and use sheath to bluntly separate muscle Insert pyloric spreader – Gently separate pyloric muscle fibers as you view the submucosa Measure length – know length of stenosis on ultrasound Distend stomach with 45-60 cc air Place omentum over myotomy

Laparoscopic Pyloromyotomy

Alternative Approaches RUQ or upper midline incision Circumumbilical incision

Complications Incomplete myotomy Mucosal perforation Wound infection

Post-operative Management Advance diet per protocol Tylenol for pain Feed Like A Pyloric (FLAP) NPO for 2 hours Pedialyte 30cc PO Q 2h X 2, Formula 30cc ½ str Q 2h X 2, Formula 30cc full str Q 2h X 2, Formula 45cc full str Q 3h ad lib

Recent Literature Reports

Intraoperative and Postoperative Data Comparison Retrospective Review – Laparoscopic, Circumumbilical and RUQ Approaches Intraoperative and Postoperative Data Comparison Characteristic LAP (n=51) RUQ (n=190) UMB (n=49) p Value Operating room time (min) 71 ± 13□ 74 ± 14† 83 ± 15‡ <0.0001 Operative time (min) 25 ± 9□ ‡ 32 ± 9† 42 ± 11 Postoperative length of stay (d) 1.8 ± 1 1.6 ± 1 0.26 Time to ad lib feedings (h) 26 ± 22 22 ± 14 26 ± 19 0.07 Conversion rate (%) 2/51 (4) JACS 201:66-70, 2005

Intraoperative and Postoperative Data Comparison Retrospective Review – Laparoscopic, Circumumbilical and RUQ Approaches Intraoperative and Postoperative Data Comparison Characteristic LAP (n=51) RUQ (n=190) UMB (n=49) p Value Complication rate (%) 4 10 14 0.23 Mucosal perforation 3 Wound infection 11 Wound dehiscence 1 Incisional hernia 2 Persistent emesis JACS 201:66-70, 2005

Children’s Mercy Hospitals and Clinics An Effective Pyloromyotomy Length In Infants Undergoing Laparoscopic Pyloromyotomy Daniel J. Ostlie, MD, Charles E. Woodall III, MD, Kerri R. Wade, RN, Charles L. Snyder, MD, George K. Gittes, MD, Ronald J. Sharp, MD, Walter S. Andrews, MD, J. Patrick Murphy, MD, George W. Holcomb III, MD, MBA Children’s Mercy Hospitals and Clinics Kansas City, Missouri Surgery 136:827-32, 2004

Purpose To evaluate whether there is an effective pyloromyotomy length that can prevent the development of an inadequate myotomy

Results October 1999 – October 2003 171 infants Mean age – 5.2 wks (± 2.8) Ultrasound Mean length– 19.52 ± 2.8 mm Mean thickness– 4.29 ± 0.7 mm Surgery 136:827-32, 2004

Results Operative time Length of myotomy 23.5 (± 8.3) min Length of myotomy 1.94 (± 0.21) cm Standardized feeding protocol – 33 pts (19%) experienced at least one feeding setback Hospitalization Postoperative–32.6 (±27.7) hrs Total – 53.2 (± 38.7) hrs Surgery 136:827-32, 2004

Results 171 Infants No mucosal perforations No gastric or duodenal injuries No inadequate pyloromyotomies Surgery 136:827-32, 2004

Conclusions Laparoscopic approach for pyloromyotomy is safe and effective The length of the myotomy can be measured effectively A pyloromyotomy length of approximately 2 cm is effective in relieving the pyloric obstruction Surgery 136:827-32, 2004

Prospective Randomized Trial of Laparoscopic vs Open Fundoplication

Open Versus Laparoscopic Pyloromyotomy For Pyloric Stenosis: A Prospective Randomized Trial Shawn D. St. Peter George W. Holcomb III Casey M. Calkins Walter S. Andrews J. Patrick Murphy Charles L. Snyder Ronald J. Sharp George K. Gittes Daniel J. Ostlie The Center for Prospective Clinical Trials Children’s Mercy Hospital Kansas City, MO

Introduction We conducted the first large prospective randomized controlled trial investigating the role of laparoscopy in treating pyloric stenosis Doxepin hydrochloride is a psychotherapeutic agent in the class of dibenzoxepin tricyclic compounds Ann Surg 244:363-370, 2006

Methods Sample Size Mean operative times were utilized from retrospective data within our institution Power = 0.80 and α = 0.05 60 patients in each arm Potentially significant complications occur infrequently Therefore, a recruitment goal of 100 patients in each arm was established These two medications are not only complimentary in their coverage, but they are chemically compatible with well-documented stability allowing for storage in the same bag, simultaneous administration, or successive administration through the same line

Assignment Individual unit randomization sequence Non-stratified Blocks of 10 Allotment obtained from randomization sequence after permission form signed These two medications are not only complimentary in their coverage, but they are chemically compatible with well-documented stability allowing for storage in the same bag, simultaneous administration, or successive administration through the same line

Interventions Operations were performed by 7 pediatric surgeons at a single institution The surgical resident (fellow) or on-call surgeon performed the operation Allotment had no influence on which surgeon performed the operation These two medications are not only complimentary in their coverage, but they are chemically compatible with well-documented stability allowing for storage in the same bag, simultaneous administration, or successive administration through the same line

Interventions Open Pyloromyotomy 2-3 cm incision, transverse right upper quadrant or upper midline Pylorus exteriorized through incision Incision in pylorus with #15 blade Muscle spreader used to complete myotomy Benson muscle spreader

Interventions Laparoscopic Pyloromyotomy 5 mm port in umbilicus 2 stab incisions right and left upper quadrants 3 mm instruments Grasper in surgeon’s left hand Blade followed by spreader in surgeon’s right hand These two medications are not only complimentary in their coverage, but they are chemically compatible with well-documented stability allowing for storage in the same bag, simultaneous administration, or successive administration through the same line

Management Diet Orders Standard diet order sets for both groups 2 feedings of Pedialyte® 2 feedings of ½ strength formula/breast milk 2 feedings of full strength formula/breast milk Resume home regimen Criteria for stopping feeds outlined in order set Discharged when home diet tolerated These two medications are not only complimentary in their coverage, but they are chemically compatible with well-documented stability allowing for storage in the same bag, simultaneous administration, or successive administration through the same line

Management Pain Control Acetaminophen (10mg/kg) PO/PR every 4 hours as needed for pain No patients received narcotics These two medications are not only complimentary in their coverage, but they are chemically compatible with well-documented stability allowing for storage in the same bag, simultaneous administration, or successive administration through the same line

Data Collection Age Weight Electrolytes on presentation Ultrasound measurements of the pylorus Operating time Time to complete advancement of diet Number of episodes of post-operative emesis Number of doses of tylenol (10mg/kg) Length of post-operative hospitalization Complications These two medications are not only complimentary in their coverage, but they are chemically compatible with well-documented stability allowing for storage in the same bag, simultaneous administration, or successive administration through the same line

Statistics Continuous variables were compared using an independent sample, 2-tailed Student’s t- test Discrete variables were analyzed with Fisher’s exact test Significance was defined as P value < of 0.05 All measures evaluated on intention-to-treat basis These two medications are not only complimentary in their coverage, but they are chemically compatible with well-documented stability allowing for storage in the same bag, simultaneous administration, or successive administration through the same line

Results Upon Presentation OPEN (n = 100) LAP (n = 100) P Value (Mean +/- S.E.) (Mean +/- S.E.) Age (weeks) 5.24 +/- 0.25 5.33 +/- 0.22 0.77 0.88 0.74 0.72 0.65 Thickness (mm) 4.17 +/- 0.08 4.16 +/- 0.09 Length (mm) 19.51 +/- 0.27 19.38 +/- 0.27 Therefore we were comparing about 3.5 yrs experience against 1.5 yrs experience Cl - (mmol/L) 99.36 +/- 0.78 99.76 +/- 0.79 HCO3 -(mmol/L) 28.18 +/- 0.51 27.86 +/- 0.49

Results Outcomes OPEN (n = 100) LAP (n = 100) P Value 0.93 (Mean +/- S.E.) (Mean +/- S.E.) OR time (mins) 19:28 +/- 0.60 19:34 +/- 0.78 Emesis (#) 2.61 +/- 0.27 1.84 +/- 0.23 Full Feeds (hrs) 21:01 +/- 2.16 19:30 +/- 1.46 LOS (hrs) 33:10 +/- 1.63 29:38 +/- 1.69 Tylenol (doses) 2.23 +/- 0.18 1.59 +/- 0.16 0.93 0.05 0.43 0.12 0.01 Therefore we were comparing about 3.5 yrs experience against 1.5 yrs experience

Results Complications 1 mucosal perforation in the open group 1 incisional hernia in the open group 1 laparoscopic case was converted to open 4 wound infections in the open group compared to 2 wound infections in the laparoscopic group (P = 0.68) This mucosal perforation was recognized at the time of surgery and repaired without effect This hernia required operative repair Wound infection was defined as requiring drainage or antibiotics prescribed by one of the participating surgeons

Results Cosmetic Outcome OPEN LAP Some examples of open pyloromyotomy Several yrs out 1 yr out Preop photos several months later on the lap

Conclusions Operative approach for pyloromyotomy has no significant influence on operating time or length of recovery Laparoscopic pyloromyotomy results in significantly less post-operative discomfort Fewer episodes of emesis and doses of tylenol Laparoscopic pyloromyotomy results in obvious cosmetic benefits Therefore we were comparing about 3.5 yrs experience against 1.5 yrs experience

Conclusions All surgeons confirmed they will perform the pyloromyotomy with the laparoscopic approach Therefore we were comparing about 3.5 yrs experience against 1.5 yrs experience

? ? ? Dr Ostlie, the PI of this study will address your questions