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

2. Gastroesophageal Reflux GER – presence of gastroesophageal reflux GERD – symptomatic gastroesophageal reflux Wt loss/FTT ALTE (AAP 2006) Pulmonary Sxs., RAD Esophagitis: pain, stricture, Barrett’s

3. GERD Barriers to Mucosal Injury LES Esophageal IAL Angle of His Esophageal motility

4. Barriers to Injury 1. LES Thickened muscle layer, distal esophagus Imperfect valve, creates pressure gradient Held in abdomen by phrenoesophageal membrane Efficacy against GER proportional to:  Length  Pressure LES relaxes normally with esophageal peristalsis Inappropriate LES relaxations – Transient LES Relaxations (TLESR)

5. Transient LES Relaxations LES relaxation not related to swallowing Thought to be the primary mechanism for GERD in children Werlin SL, et al: J Peds 97:244-249, 1980

6. Barriers to Injury 2. IAL Esophagus Adults -> 3 cm, 100% LES competency - 3 cm, 64% - <1 cm, 20% Important to mobilize intraabdominal esophagus and secure it into abdomen *DeMeester, et al: Am J Surg 137: 39-46, 1979

7. Barriers to Injury Normally, an acute angle When obtuse, more prone to GER Important consideration following gastrostomy 3. Angle of His

8. Barriers to Injury 4. Esophageal Motility motility, impaired clearance of gastric refluxate, mucosal injury

9. Treatment Relieve symptoms Heal mucosal injury Prevent complications  ALTE, pneumonia, stricture

10. Treatment Options Medical Surgical Endoluminal

11. GERD SURGICAL CONSIDERATIONS

12. Preoperative Evaluation 24 hr pH study Upper GI contrast study Endoscopy Endoscopy with biopsy Gastric emptying study ? Esophageal motility study ?

13. Preoperative Evaluation Gastric Emptying Study ?

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

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

16. Advantages of Laparoscopy Reduced discomfort Reduced hospitalization Faster return to routine activities (school, work, play) Cosmesis

17. ISSUES/QUESTIONS

18. Laparoscopic Fundoplication Significant hx of cardiac disease Significant hx of lung disease  BPD  Significant O 2 still needed Chronic NICU baby Previous upper abdominal operations? 1. When is it not a good option?

19. Pneumoperitoneum SVR PVR SV CI Venous Return (Head up) pCO 2 FRC pH pO 2

20. 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

21. Laparoscopic Fundoplication 2.Can a loose, floppy, complete (Nissen) fundoplication be performed without ligation of the short gastric vessels?

22. Laparoscopic Fundoplication No

23. Laparoscopic Fundoplication 3.Is dysphagia a common problem following laparoscopic Nissen fundoplication in infants and children?

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

25. Laparoscopic Fundoplication 4. Can stab (3mm) incisions be used rather than cannulas for laparoscopic operations and is there a financial advantage?

26. Laparoscopic Fundoplication

27. 5. Is there a financial advantage with the laparoscopic approach when compared to the open operation?

28. 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

29. Laparoscopic Fundoplication 6. Should the esophagus be extensively mobilized in laparoscopic fundoplication?

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

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

32. Laparoscopic Fundoplication Current Technique

33. Personal Series - CMH Jan 2000 – March 2002 130 Pts No Esophagus – Crural Sutures Extensive Esophageal Mobilization Mean age/weight 21 mo/10 kg Mean operative time93 minutes Transmigration wrap15 (12%) Postoperative dilation0 APSA 2006 J Pediatr Surg 42:25-30, 2007

34. Personal Series - CMH April 2002 – December 2004 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

35. 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.

36. 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

37. 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)

38. 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

39. Prospective, Randomized Trial 2 Institutions: CMH, CH-Alabama Power Analysis: 360 Patients Primary endpoint-transmigration rate (12% vs.5%-retrospective data) 2 Groups: minimal vs. extensive esophageal dissection Both groups receive esophago-crural sutures APSA, 2010

40. Evidence Based Studies in MIS 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

41. Evidence Based Studies in MIS Minimal vs Extensive Esophageal Mobilization During Laparoscopic Fundoplication Extensive Esophageal Mobilization (N=70) 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

42. Operative Results Open Operations

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

44. Re-Do Fundoplication 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

45. Re-Do Fundoplication Operative Technique 21/249Pts Laparoscopic Re-Do – 10 No SIS – 9  Open Redo with SIS -(1) SIS1

46. Re-Do Fundoplication Operative Technique 21/249 Pts

47. Redo Laparoscopic Fundoplication

48. 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 ASA Meeting, April ‘06

49. Postoperative Studies Nissen Fundoplication number and magnitude TLESR 1, 2 Disruption efferent vagal input to GE junction with TLESR 3 1.Ireland, et al: Gastroenterology 106:1714-1720, 1994 2.Straathof, et al: Br J Surg 88: 1519-1524, 2001 3.Sarani, et al: Surg Endosc 17:1206-1211 2003

50. Laparoscopic Nissen Fundoplication Summary LNF is an effective approach for surgical correction of GERD Advantages include reduced discomfort, reduced hospitalization and cosmesis Fundoplication appears to work by decreasing the number and magnitude of TLESR

51. Laparoscopic Nissen Fundoplication Summary The use of stab incisions for instrument access results in significant financial savings to the patient and institution. The incidence of transmigration of the fundoplication wrap has been markedly reduced with the use of esophageal-crural sutures and minimal esophageal mobilization. The long-term functional results should be equivalent to the open operation. The major advantages lie in reduced discomfort and hospitalization, faster return to routine activities and cosmesis.

52. QUESTIONS www.cmhcenterforminimallyinvasivesurgery.com www.centerforprospectiveclinicaltrials.com