Transcript Slide 1

Current Thoughts About Laparoscopic Fundoplication in Infants and Children 2010 WOFAPS Meeting George W. Holcomb, III, M.D., MBA Surgeon-in-Chief Children’s Mercy Hospital Kansas City, Missouri

Gastroesophageal Reflux

GER – presence of gastroesophageal reflux GERD – symptomatic gastroesophageal reflux

Wt loss/FTT

ALTE

Pulmonary Sxs., RAD

Esophagitis: pain, stricture, Barrett’s

GERD

Barriers to Mucosal Injury

Lower esophageal sphincter (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

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

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 ?

Esophageal motility study - not needed in children?

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

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

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

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)

Laparoscopic Fundoplication Issues/Questions

1) Effects of Pneumoperitoneum

• • • • •

SVR PVR SV CI Venous Return (Head up)

• • • •

pCO 2 FRC pH pO 2

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

Laparoscopic Fundoplication

2) 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

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

Laparoscopic Fundoplication

Procedure (n) The Use of Stab Incisions Nissen (209) Nissen (14) Heller Myotomy (7) Appendectomy (102) Meckel’s Diverticulum (2) Pyloromyotomy (77) Cholecystectomy (31) Pullthrough (20) Splenectomy (21) Adrenalectomy (6) UDT (15) Varicocele (5) Ovarian (2) Totals (511) 2000-2002 Used/case 1 2 2 2 2 1 2 2 2 2 1 1 1 714 Saved/case 4 3 3 1 1 2 2 1 2 2 2 2 2 1337 PAPS, 2003 JPS 38:1837-1840, 2003

Laparoscopic Fundoplication

4) 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 LOS (1.2 vs 2.9 days) Initial Feeds (7.3 vs 27.9 hrs) Full Feeds (21.8 vs 42.9 hrs) P Value <0.01

<0.01

<0.01

Favoring OF Op Time (77 vs 91 min) P Value 0.03

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

Laparoscopic Fundoplication 5) Should the esophagus be extensively mobilized?

Technique 2000 - 2002

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 - 2010

Why The Change in Technique?

Personal Series - CMH Jan 2000 – March 2002 Group I - 130 Pts No Esophagus – Crural Sutures Extensive Esophageal Mobilization Mean age/weight Mean operative time Transmigration wrap Postoperative dilation 21 mo/10 kg 93 minutes 15 (12%) 0 APSA, 2006 J Pediatr Surg 42:25-30, 2007

Personal Series - CMH April 2002 – December 2004 Group II - 119 Pts Esophagus – Crural Sutures Minimal Esophageal Mobilization Mean age/weight Mean operative time Transmigration wrap Postoperative dilation 27 mo/11 kg 102 minutes 6 (5%) 1 APSA, 2006 J Pediatr Surg 42:25-30, 2007

Summary 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.

Group II 119 Patients Esophago-Crural Sutures 2 silk sutures (9, 3 o’clock) 3 silk sutures (9, 12, 3 o’clock) 4 silk sutures (8, 11, 1, 4 o’clock) # Patients Transmigration % 20 5 25% 43 56 1 0 2.3% 0%

Patients Less Than 60 Months

Group I Jan 00-March 02 Group II April 02-Dec 04 P Value Mean Age (mos) 117 Pts 10.26

102 Pts 10.95

0.650

Mean Wt (kg) Gastrostomy Neuro Impaired 7.03

47% 71% 7.17

46% 61% 0.801

0.893

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

Patients Less Than 24 Months Group I Jan 00-March 02 Group II April 02-Dec 04 P Value 104 Pts 93 Pts 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

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

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

Minimal vs Extensive Esophageal Mobilization During Laparoscopic Fundoplication Preoperative Demographics 177 Patients Age (yrs) Extensive Esophageal Mobilization (N=87) 1.9 +/- 3.3

Minimal Esophageal Mobilization (N=90) 2.5 +/- 3.5

P-Value 0.30

Weight (kg) Neurologically Impaired (%) Operating Time (Minutes) 10.7 +- 11.9

51.7

100 +/- 34 12.6 +/- 18.2

54.4

95 +/- 37 0.44

0.76

0.37

APSA, 2010 Accepted, J Pediatr Surg

Minimal vs Extensive Esophageal Mobilization During Laparoscopic Fundoplication Results 177 Patients 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 Accepted, J Pediatr Surg

Current Study

Analysis (80% power, patients

- 0.05) – 110

Minimal esophageal dissection in all patients

4 esophago-crural sutures vs. no sutures

No Esophago-crural Sutures

Study Wheatley (Michigan) 1974-1989 Caniano (Ohio State) 1976 - 1988 Dedinsky (Indiana) 1975-1985 Fonkalsrud (UCLA) 1976-1996 # Pts 242 358 429 7467 Operative Results Open Operations % Re-op 12% (29) Herniation 3 Wrap Dehiscence 14 Other 3 6% (21) 6.7% (29) 7.1% 16 29 2 3

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

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 (±1.7) mos redo – 14.1

F/U – Minimum -19 mos Mean 34 mos J Pediatr Surg 42:1298-1301, 2007

Re-Do Fundoplication 21/249Pts

SIS – 8: no recurrences

No SIS – 13

4 recurrences (31%)

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

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

www.centerforprospectiveclinicaltrials.com

www.cmhcenterforminimallyinvasivesurgery.com