1. Current Thoughts About Laparoscopic Fundoplication in Infants and Children George W. Holcomb, III, M.D., MBA Surgeon-in-Chief Children’s Mercy Hospital Kansas City, Missouri

2. Gastroesophageal Reflux GER – presence of gastroesophageal reflux GERD – symptomatic gastroesophageal reflux Wt loss/FTT ALTE Pulmonary Sxs., RAD Esophagitis: pain, stricture, Barrett’s

3. GERD Barriers to Mucosal Injury Lower esophageal sphincter (LES) Esophageal IAL Angle of His Esophageal motility

4. What Do We Know Now That We Did Not Know in 2000?

5. Preoperative Evaluation 24 hr pH study – gold standard in many centers  Only measures acid reflux Impedance – acid & alkaline reflux Upper GI contrast study -reflux seen in only 30% Endoscopy - visualization only not sensitive Endoscopy with biopsy – probably most sensitive Gastric emptying study ? – not performed at initial operation Esophageal motility study - not needed in children?

6. Children’s Mercy Hospital (Jan 2000 – June 2007) 843 fundoplications ( 3.6% op. vol.) UGI – 656 pts pH study – 379 pts Sensitivity UGI – 30.8% AAP, 2009 J Pediatr Surg 45:1169-1172, 2010

7. Children’s Mercy Hospital UGI – 656 pts Abnormality (other than GER) – 30 pts (4.5%) Suspected malrotation – 26 pts (4.0%) Confirmed (16 pts)No malrotation (6 pts)Prev. Ladd (4 pts) AAP, 2009 J Pediatr Surg 45:1169-1172, 2010

8. Children’s Mercy Hospital Preoperative UGI – 656 pts Influences management - 4% Malrotation is the most common finding AAP, 2009 J Pediatr Surg 45:1169-1172, 2010

9. Preoperative Evaluation Gastric Emptying Study ?

10. GERD Fundoplication Indications for operation (U.S.)  Failure of medical therapy  ALTE/weight loss in infants  Refractory pulmonary symptoms  Neurologically impaired child who needs gastrostomy

11. Options for Fundoplication Laparoscopic vs open Complete (Nissen) vs Partial (Thal, Boix-Ochoa, Toupet)

12. Laparoscopic Fundoplication Issues/Questions

13. 1)Effects of Pneumoperitoneum SVR PVR SV CI Venous Return (Head up) pCO 2 FRC pH pO 2

14. Proceed With Caution  VSD with reactive pulmonary HTN  CAVC – ( PVR 2 o to pCO 2, pO 2, pH)  Neonates (in general) with reactive or persistent P- HTN  Palliated defects with passive pulmonary blood flow (Glenn, Fontan procedures) – Risk is pulmonary flow, reversal of flow thru shunt and clotting of shunt  Any defect adversely affected by SVR HLHS CHF (unrepaired septal defects: VSD, CAVC) Risk is acute CHF 2 o to afterload & shunting, unbalancing the defect

15. Laparoscopic Fundoplication 2)Is dysphagia a common problem following laparoscopic Nissen fundoplication in infants and children?

16. Intraoperative Bougie Sizes PAPS, 2002 J Pediatr Surg 37:1664-1666, 2002

17. Laparoscopic Fundoplication 3)Can stab (3mm) incisions be used rather than cannulas for laparoscopic operations?

18. Laparoscopic Fundoplication

19. The Use of Stab Incisions 2000-2002 PAPS, 2003 JPS 38:1837-1840, 2003

20. Laparoscopic Fundoplication 4)Is there a financial advantage with the laparoscopic approach when compared to the open operation?

21. Clinical and Financial Analysis of Pediatric Laparoscopic versus Open Fundoplication 100 Patients Favoring LFP ValueFavoring OFP Value LOS (1.2 vs 2.9 days)<0.01Op Time (77 vs 91 min)0.03 Initial Feeds (7.3 vs 27.9 hrs) Full Feeds (21.8 vs 42.9 hrs) <0.01 Hospital Room ($1290 vs $2847) Pharmacy ($180 vs $461) Equipment ($1006 vs $1609) 0.004 0.01 0.003 Anesthesia ($389 vs $475) Operating Suite ($4058 vs $5142) Central Supply/Sterilization ($1367 vs $2515) 0.01 0.04 <0.001 Total Charges Similar (LF - $11,449 OF - $11,632) IPEG 2006 J Lap Endosc Surg Tech 17:493-496,2007

22. Laparoscopic Fundoplication 5) Should the esophagus be extensively mobilized? Technique 2000 - 2002 Please use this link if you experience problems viewing the video above.this link

23. Current Thoughts Technique 2003 - 2010 1.Less mobilization of esophagus 2.Keep peritoneal barrier b/w esophagus & crura

24. Current Thoughts 3.Secure esophagus to crura at 8, 11, 1 and 4 o’clock

25. Laparoscopic Fundoplication Current Technique - 2010 Please use this link if you experience problems viewing the video above.this link

26. Why The Change in Technique?

27. Personal Series - CMH Jan 2000 – March 2002 Group I - 130 Pts No Esophagus – Crural Sutures Extensive Esophageal Mobilization Mean age/weight 21 mo/10 kg Mean operative time93 minutes Transmigration wrap15 (12%) Postoperative dilation 0 APSA, 2006 J Pediatr Surg 42:25-30, 2007

28. Personal Series - CMH April 2002 – December 2004 Group II - 119 Pts Esophagus – Crural Sutures Minimal Esophageal Mobilization Mean age/weight 27 mo/11 kg Mean operative time102 minutes Transmigration wrap6 (5%) Postoperative dilation1 APSA, 2006 J Pediatr Surg 42:25-30, 2007

29. The relative risk of wrap transmigration in patients without esophago-crural sutures and with extensive esophageal mobilization was 2.29 times the risk if these sutures were utilized and if minimal esophageal dissection was performed. Summary

30. Group II 119 Patients Esophago-Crural Sutures # PatientsTransmigration% 2 silk sutures20525% (9, 3 o’clock) 3 silk sutures4312.3% (9, 12, 3 o’clock) 4 silk sutures5600% (8, 11, 1, 4 o’clock)

31. Patients Less Than 60 Months Group I Jan 00-March 02 117 Pts Group II April 02-Dec 04 102 Pts P Value Mean Age (mos)10.2610.950.650 Mean Wt (kg)7.03 7.170.801 Gastrostomy47%46%0.893 Neuro Impaired71%61%0.118 Wrap Transmigration 14 (12%) 6 (6%)0.159 The relative risk of transmigration of the wrap is 2.03 times greater for Group I than for Group II APSA, 2006 J Pediatr Surg 42:25-30, 2007

32. Patients Less Than 24 Months Group I Jan 00-March 02 104 Pts Group II April 02-Dec 04 93 Pts P Value Mean Age (mos)6.998.150.175 Mean Wt (kg)6.326.460.759 Gastrostomy46% 0.999 Neuro Impairment 73%60%0.069 Wrap Transmigration 13 (12%)6 (6%).226 The relative risk of transmigration of the wrap is 1.94 times greater for Group I than for Group II APSA, 2006 J Pediatr Surg 42:25-30, 2007

33. Prospective, Randomized Trial 2 Institutions: CMH, CH-Alabama Power analysis using retrospective data (12% vs 5%) : 360 patients Primary endpoint -- transmigration rate 2 groups: minimal vs. extensive esophageal dissection Both groups received esophago-crural sutures Stratified for neurological status UGI contrast study one year post-op APSA, 2010

34. Minimal vs Extensive Esophageal Mobilization During Laparoscopic Fundoplication Extensive Esophageal Mobilization (N=87) Minimal Esophageal Mobilization (N=90) P-Value Age (yrs) 1.9 +/- 3.32.5 +/- 3.50.30 Weight (kg) 10.7 +- 11.912.6 +/- 18.20.44 Neurologically Impaired (%) 51.754.40.76 Operating Time (Minutes) 100 +/- 3495 +/- 370.37 APSA, 2010 J Pediatr Surg 43:163-169, 2011 Preoperative Demographics 177 Patients

35. Minimal vs Extensive Esophageal Mobilization During Laparoscopic Fundoplication Extensive Esophageal Mobilization (N=87) Minimal Esophageal Mobilization (N=90) P- Value Postoperative Wrap Transmigration (%) 30.0%7.8%0.002 Need for Re-do Fundoplication (%) 18.4%3.3%0.006 APSA, 2010 J Pediatr Surg 43:163-169, 2011 Results 177 Patients

36. Current Study Analysis (80% power, α - 0.05) – 110 patients Minimal esophageal dissection in all patients 4 esophago-crural sutures vs. no sutures

37. No Esophago-crural Sutures Please use this link if you experience problems viewing the video above.this link

38. Operative Results Open Operations

39. Re-Do Fundoplication (Personal Series) Jan 00 – March 02 15/130 Pts – 12% April 02 – December 06 7/184 Pts – 3.8% J Pediatr Surg 42:1298-1301, 2007

40. Re-Do Fundoplication (Personal Series) 22 Pts (2000 – 2006) All but one had transmigration of wrap Mean age initial operation – 12.6 (±5.8) mos 11 had gastrostomy Mean time b/w initial operation & 1 st redo – 14.1 (±1.7) mos F/U – Minimum -19 mos Mean - 34 mos J Pediatr Surg 42:1298-1301, 2007

41. Re-Do Fundoplication 21/249Pts SIS – 8:no recurrences No SIS – 13  4 recurrences (31%)

42. SIS and Paraesophageal Hernia Repair Multicenter, prospective randomized trial 108 patients Recurrence: 7% vs 25% (1 o repair) No mesh related complications Oelschlager BK, et al Ann Surg 244:481-490, 2006 ASA Meeting, 2006

43. QUESTIONS www.cmhmis.com www.cmhclinicaltrials.com