Current Thoughts About Laparoscopic Fundoplication in

Infants and Children

George W. Holcomb, III, M.D., MBA

Surgeon-in-ChiefChildren’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

GERDBarriers to Mucosal Injury

• LES

• Esophageal IAL

• Angle of His

• Esophageal motility

Barriers to Injury1. 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 Injury2. 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

• Normally, an acute angle

• When obtuse, more prone to GER

• Important consideration following gastrostomy

3. Angle of His

Barriers to Injury

4. Esophageal Motility

• motility, impaired clearance of gastric refluxate, mucosal injury

GERD

SURGICAL CONSIDERATIONS

What Do We Know Now That

We Did Not Know in 2000?

Preoperative Evaluation• 24 hr pH study – gold standard in many centers

• Impedance – acid & alkaline reflux

• Upper GI contrast study -reflux seen in 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 HospitalJan 2000 – June 2007843 fundoplications

( 3.6% op. vol.)

UGI – 656 pts

pH study – 379 ptsSensitivity UGI – 30.8%

AAP, 2009AAP, 2009

J Pediatr Surg 4:1169-1172, 2010J Pediatr Surg 4:1169-1172, 2010

Children’s Mercy HospitalUGI – 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, 2009AAP, 2009

J Pediatr Surg 4:1169-1172, 2010J Pediatr Surg 4:1169-1172, 2010

Children’s Mercy Hospital

UGI – 656 pts

Influences management - 4%

Malrotation is the most common finding

AAP, 2009AAP, 2009J Pediatr Surg 4:1169-1172, 2010J Pediatr Surg 4:1169-1172, 2010

Preoperative EvaluationGastric Emptying Study ?

GERDFundoplication

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)

ISSUES/QUESTIONSISSUES/QUESTIONS

1) Effects of Pneumoperitoneum

• SVR

• PVR

• SV

• CI

• Venous Return (Head up)

• pCO2

• FRC

• pH

• pO2

Proceed With Caution VSD with reactive pulmonary HTN

CAVC – ( PVR 2o to pCO2, pO2, 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 2o 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, 2002PAPS, 2002

JPS 37:1664-1666, 2002JPS 37:1664-1666, 2002

Laparoscopic Fundoplication

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

Laparoscopic Fundoplication

The Use of Stab IncisionsProcedure (n) Used/case Saved/case Nissen (209) 1 4

Nissen (14) 2 3

Heller Myotomy (7) 2 3

Appendectomy (102) 2 1

Meckel’s Diverticulum (2) 2 1

Pyloromyotomy (77) 1 2

Cholecystectomy (31) 2 2

Pullthrough (20) 2 1

Splenectomy (21) 2 2

Adrenalectomy (6) 2 2

UDT (15) 1 2

Varicocele (5) 1 2

Ovarian (2) 1 2

Totals (511) 714 1337 PAPS, 2003PAPS, 2003

JPS 38:1837-1840, 2003JPS 38:1837-1840, 2003

Cost Savings from Stab IncisionsProcedure (n) Step Pt./Instit. Savings ($) Ethicon Pt./Instit. Savings ($) Nissen (209) 117,040 / 51,832 76,912 / 4,276 Nissen (14) 5,880 / 2,604 3,864 / 1,722 Heller (7) 2,940 / 1,302 1,932 / 861 Appy (102) 14,280 / 6,324 9,384 / 4,182 Meckel’s (2) 280/ 124 184 / 82 Pyloric (77) 21,560 / 9,548 14,168 / 6,314 Chole (31) 8,680 / 3,844 5,704 / 2,542 Pullthrough (20) 2,800 / 1,240 1,840 / 820 Spleens (21) 5,880 / 2,604 3,864 / 1,722 Adrenal (6) 1,680 / 744 1,104 / 492 UDT (15) 4,200 / 1,860 2,760 / 1,230 Varicocele (5) 1,400 / 620 920 / 410 Ovarian (2) 560 / 248 368 / 164 Total = 511 $187,180/$82,894 $123,004/$54,817

PAPS, 2003PAPS, 2003JPS 38:1837-1840, 2003JPS 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 P Value Favoring OF P Value

LOS (1.2 vs 2.9 days) <0.01 Op 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

<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 2006IPEG 2006J Lap Endosc Surg Tech 17:493-496,2007J Lap Endosc Surg Tech 17:493-496,2007

Laparoscopic Fundoplication

5. Should the esophagus be extensively mobilized in laparoscopic fundoplication?

Please use this link if you experience problems viewing the video above.

Current ThoughtsTechnique 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 FundoplicationCurrent Technique - 2010

Please use this link if you experience problems viewing the video above.

Why The Change in Technique?

Personal Series - CMHJan 2000 – March 2002

130 PtsNo 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 APSA, 2006 J Pediatr Surg 42:25-30, 2007J Pediatr Surg 42:25-30, 2007

Personal Series - CMHApril 2002 – December 2004

119 PtsEsophagus – 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 APSA 2006 J Pediatr Surg 42:25-30, 2007J 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 24 MonthsGroup I

Jan 00-March 02

104 Pts

Group IIApril 02-Dec 04

93 PtsP 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

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 APSA 2006 J Pediatr Surg 42:25-30, 2007J 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

Extensive Esophageal Mobilization (N=87)

Minimal Esophageal Mobilization (N=90)

P-Value

Age (yrs) 1.9 +/- 3.3 2.5 +/- 3.5 0.30

Weight (kg) 10.7 +- 11.9 12.6 +/- 18.2 0.44

Neurologically Impaired (%)

51.7 54.4 0.76

Operating Time (Minutes)

100 +/- 34 95 +/- 37 0.37

Preoperative Demographics

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, 2010APSA, 2010J Pediatr Surg 46:163-169, 2011J Pediatr Surg 46:163-169, 2011

Results

Current Study

• Analysis (80% power,α- 0.05) – 110 patients

• Minimal esophageal dissection in all patients

• 4 esophago-crural sutures vs. no sutures

No Esophago-crural Sutures

Please use this link if you experience problems viewing the video above.

Study # Pts % Re-op Herniation Wrap Dehiscence

Other

Wheatley (Michigan) 1974-1989

242 12%

(29)

3 14 3

Caniano (Ohio State) 1976 - 1988

358 6%

(21)

16 2 3

Dedinsky (Indiana) 1975-1985

429 6.7%

(29)

29

Fonkalsrud (UCLA)

1976-1996

7467 7.1%

Holcomb (CMH)

2000-2006

314 22 21 1

Operative ResultsOpen Operations

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, 2007J 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, 2007J Pediatr Surg 42:1298-1301, 2007

Re-Do Fundoplication21/249Pts

• 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% (1o repair)

• No mesh related complications

Oelschlager BK, et alOelschlager BK, et al

ASA Meeting, April ‘06ASA Meeting, April ‘06

Postoperative StudiesNissen Fundoplication

• number and magnitude TLESR 1, 2

• Disruption efferent vagal input to GE junction with TLESR3

1.1. Ireland, et al: Gastroenterology 106:1714-1720, 1994Ireland, et al: Gastroenterology 106:1714-1720, 1994

2.2. Straathof, et al: Br J Surg 88: 1519-1524, 2001Straathof, et al: Br J Surg 88: 1519-1524, 2001

3.3. Sarani, et al: Surg Endosc 17:1206-1211 2003Sarani, et al: Surg Endosc 17:1206-1211 2003

QUESTIONS

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www.cmhclinicaltrials.com