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Current Thoughts About Laparoscopic Fundoplication in Infants and Children George W. Holcomb, III, M.D., MBA Children’s Mercy Hospital Kansas City, Missouri 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 GERD Barriers to Mucosal Injury • LES • Esophageal IAL • Angle of His • Esophageal motility 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) 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 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 Barriers to Injury 3. Angle of His • Normally, an acute angle • When obtuse, more prone to GER • Important consideration following gastrostomy Barriers to Injury 4. Esophageal Motility • motility, impaired clearance of gastric refluxate, mucosal injury Treatment • Relieve symptoms • Heal mucosal injury • Prevent complications ALTE, pneumonia, stricture Treatment Options • Medical • Surgical • Endoluminal GERD SURGICAL CONSIDERATIONS Preoperative Evaluation • 24 hr pH study • Upper GI contrast study • Endoscopy • Endoscopy with biopsy • Gastric emptying study ? • Esophageal motility study ? Preoperative Evaluation Gastric Emptying Study ? GERD Fundoplication Indications for operation Failure of medical therapy ALTE/weight loss in infants Refractory pulmonary symptoms Neurologically impaired child who needs gastrostomy Options for Fundoplication • Laparoscopic vs open • Complete (Nissen) vs Partial (Thal, Boix-Ochoa, Toupet) Advantages of Laparoscopy • Reduced discomfort • Reduced hospitalization • Faster return to routine activities (school, work, play) • Cosmesis ISSUES/QUESTIONS Laparoscopic Fundoplication 1. When is it not a good option? • Significant hx of cardiac disease • Significant hx of lung disease BPD Significant O2 still needed • Chronic NICU baby • Previous upper abdominal operations? Pneumoperitoneum • SVR • pCO2 • PVR • FRC • SV • pH • CI • pO2 • Venous Return (Head up) Proceed With Caution VSD with reactive pulmonary HTN PVR 2o to pCO2, pO2, pH) Neonates (in general) with reactive or persistent PHTN 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 2o to afterload & shunting, unbalancing the defect CAVC – ( Laparoscopic Fundoplication 2. Can a loose, floppy, complete (Nissen) fundoplication be performed without ligation of the short gastric vessels? Laparoscopic Fundoplication No Laparoscopic Fundoplication 3. Is dysphagia a common problem following laparoscopic Nissen fundoplication in infants and children? Intraoperative Bougie Sizes PAPS 2002 J Pediatr Surg 37:1664-1666, 2002 Laparoscopic Fundoplication 4. Can stab (3mm) incisions be used rather than cannulas for laparoscopic operations and is there a financial advantage? Laparoscopic Fundoplication Laparoscopic Fundoplication 5. Is there a financial advantage with the laparoscopic approach when compared to the open operation? Clinical and Financial Analysis of Pediatric Laparoscopic versus Open Fundoplication 100 Patients Favoring LF P Value LOS (1.2 vs 2.9 days) <0.01 Initial Feeds (7.3 vs 27.9 hrs) <0.01 Full Feeds (21.8 vs 42.9 hrs) <0.01 Hospital Room ($1290 vs $2847) Favoring OF P Value Op Time (77 vs 91 min) 0.03 0.004 Anesthesia ($389 vs $475) 0.01 Pharmacy ($180 vs $461) 0.01 Operating Suite ($4058 vs $5142) 0.04 Equipment ($1006 vs $1609) 0.003 Central Supply/Sterilization ($1367 vs $2515) <0.001 Total Charges Similar (LF - $11,449 OF - $11,632) IPEG 2006 J Lap Endosc Surg Tech 17:493-496, 2007 Laparoscopic Fundoplication 6. Should the esophagus be extensively mobilized in laparoscopic fundoplication? Current Thoughts Technique 2003 -2010 1. Less mobilization of esophagus 2. Keep peritoneal barrier b/w esophagus & crura Current Thoughts 3. Secure esophagus to crura at 8, 11, 1 and 4 o’clock Laparoscopic Fundoplication Current Technique 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 time 93 minutes Transmigration wrap 15 (12%) Postoperative dilation 0 APSA 2006 J Pediatr Surg 42:25-30, 2007 Personal Series - CMH April 2002 – December 2004 119 Pts Esophagus – Crural Sutures Minimal Esophageal Mobilization Mean age/weight 27 mo/11 kg Mean operative time 102 minutes Transmigration wrap 6 (5%) Postoperative dilation 1 APSA 2006 J Pediatr Surg 42:25-30, 2007 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. Patients Less Than 60 Months Mean Age (mos) Group I Jan 00-March 02 Group II April 02-Dec 04 117 Pts 102 Pts P Value 10.26 10.95 0.650 Mean Wt (kg) 7.03 7.17 0.801 Gastrostomy 47% 46% 0.893 Neuro Impaired 71% 61% 0.118 6 (6%) 0.159 Wrap Transmigration 14 (12%) The relative risk of transmigration of the wrap is 2.03 times greater for Group I than for Group II Group II 119 Patients Esophago-Crural Sutures # Patients Transmigration % 2 silk sutures (9, 3 o’clock) 20 5 25% 3 silk sutures (9, 12, 3 o’clock) 43 1 2.3% 4 silk sutures (8, 11, 1, 4 o’clock) 56 0 0% Patients Less Than 24 Months Group I Jan 00-March 02 Group II April 02-Dec 04 104 Pts 93 Pts P Value Mean Age (mos) 6.99 8.15 0.175 Mean Wt (kg) 6.32 6.46 0.759 Gastrostomy 46% 46% 0.999 Neuro Impairment 73% 60% 0.069 6 (6%) .226 Wrap Transmigration 13 (12%) The relative risk of transmigration of the wrap is 1.94 times greater for Group I than for Group II 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 Evidence Based Studies in MIS Minimal vs Extensive Esophageal Mobilization During Laparoscopic Fundoplication Age (yrs) Weight (kg) Neurologically Impaired (%) Operating Time (Minutes) Extensive Esophageal Mobilization (N=87) Minimal Esophageal Mobilization (N=90) P-Value 1.9 +/- 3.3 2.5 +/- 3.5 0.30 10.7 +- 11.9 12.6 +/- 18.2 0.44 51.7 54.4 0.76 100 +/- 34 95 +/- 37 0.37 APSA, 2010 Evidence Based Studies in MIS Minimal vs Extensive Esophageal Mobilization During Laparoscopic Fundoplication Extensive Esophageal Mobilization (N=70) Minimal Esophageal Mobilization (N=90) PValue Postoperative Wrap Transmigration (%) 30.0% 7.8% 0.002 Need for Re-do Fundoplication (%) 18.4% 3.3% 0.006 APSA, 2010 Operative Results Open Operations Study # Pts % Re-op Herniation Wrap Dehiscence Other Wheatley (Michigan) 1974-1989 242 12% 3 14 3 Caniano (Ohio State) 1976 - 1988 358 16 2 3 Dedinsky (Indiana) 1975-1985 Fonkalsrud (UCLA) 1976-1996 Holcomb (CMH) 2000-2006 (29) 6% (21) 429 6.7% 29 (29) 7467 7.1% 314 22 21 1 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 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 & 1st redo – 14.1 (±1.7) mos • F/U – Minimum -19 mos Mean 34 mos J Pediatr Surg 42:1298-1301, 2007 Re-Do Fundoplication Operative Technique 21/249Pts Laparoscopic Re-Do – 10 • No SIS – 9 Open Redo with SIS - (1) • SIS 1 Re-Do Fundoplication Operative Technique 21/249 Pts Redo Laparoscopic Fundoplication SIS and Paraesophageal Hernia Repair • • • • Multicenter, prospective randomized trial 108 patients Recurrence: 7% vs 25% (1o repair) No mesh related complications Oelschlager BK, et al ASA Meeting, April ‘06 Postoperative Studies Nissen Fundoplication • number and magnitude TLESR 1, 2 • Disruption efferent vagal input to GE junction with TLESR3 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 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 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. QUESTIONS www.centerforprospectiveclinicaltrials.com www.cmhcenterforminimallyinvasivesurgery.com