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Laparoscopic Antireflux Surgery

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Laparoscopic Antireflux Surgery o 3','3'q. ), IMPROVING OUTCOMES FOLLOWING SURGERY FOR GASTRO.OESOPHAGEAL REFLUX DISEASE . LAPAROSCOPIC ANTIREFLUX SURGERY Thesis submitted in November,1997 for the degree of Doctor of Medicine in the University of Adelaide by David Ian'Watson M.B.,B.S. (Adel) 1984 F.R.A.C.S. (Gen Surg) 1992 The work described in this thesis was performed within the Department of Surgery at the University of Adelaide, and the Royal Adelaide Centre for Endoscopic Surgery at the Royal Adelaide Hospital 11 This work is dedicated to my wife Claire and my children James, Edward and Timotþ. I am forever indebted to them for their ongoing patience, considerable sacrifices, and unending support which has enabled this work to be completed. 111 SHORT TABLE OF CONTENTS 1 OUTCOME FOLLOWING LAPAROSCOPIC ANTIREFLUX SURGERY 2 1.1 Laparoscopic antireflux surgery - literature review 3 l-2 Outcome of prospective studies assessing outcomes following laparoscopic antireflux surgery 31 2 LABORATORY RESEARCH 122 2.I Comparison of anterior, posterior and total fundoplication using a viscera model t23 2-2 Effîcacy of anterior, posterior and total fundoplication in a porcine model r32 3 CONTROLLED TRIALS ASSESSING STRATEGIES TO IMPROVE OUTCOMES FOLLOWING SURGERY FOR GASTRO.OESOPHAGEAL REFLUX 146 3.1 Prospective randomised trial of laparoscopic versus open Nissen fundoplication for gastro-oesophageal reflux disease 147 3-2 Prospective double blind randomised trial of laparoscopic Nissen fundoplication with division and without division of short gastric vessels 166 3.3 Prospective double blind randomised trial of laparoscopic anterior partial versus Nissen fundoplication 191 4 CONCLUSIONS 214 5 BIBLIOGRAPHY 227 6 APPENDIX 256 1V TABLE OF CONTENTS ABSTRACT x DECLARATION xiii ACKNOWLEDGEMENTS xiv PREFACE xvi ANTIREFLUX 1 OUTCOME FOLLOWING LAPAROSCOPIC ., SURGERY 1.1 LAPAROSCOPIC ANTIREFLUX SURGERY . LITERATURE REVIE\ry 3 1.1.1 OPEN NISSEN FUNDOPLICATION 3 T.1.2 RANDOMISED TRIALS FOR OPEN FUNDOPLICATION 5 L.1.2-I Nissen versus partial fundoplication 6 Thor and Silander 6 |.I.2.IJ 'Walker I.1.2.1.2 et al 7 I.1.2.I.3 Lundell et al 8 I-1.2.1.4 DeMeester et al 9 1.I.2.2 Other trials 10 I.1.2.2.L Hill et al 10 1.1 2.2.2 Janssen et al 10 1.1 2.2.3 Luostarinen et al 11 1.1 2.2.4 Spechler et al 11 1.1.3 INDICATIONS FOR SURGERY 11 T.1.4 APPROPRIATE SITUATIONS FOR THE APPLICATION OF A 1.1.5 EARLY RESULTS AND COMPLICATIONS FOLLOWING LAPAROSC OPIC FUNDOPLICATION 13 1.1 .5.1 Pneumothorax t6 1.1 .5.2 Vascular injury L6 1.1 .5.3 Paraoesophageal hiatus herniation t7 1.1 .5.4 Dysphagia t7 1.1 .5.5 Pulmonaryembolism 18 1.1 .5.6 Perforation of the gastrointestinal tract 18 1.1 .5.7 Mortality 19 1.1.6 LAPAROSCOPIC VERSUS OPEN SURGERY 19 1. 1.6.1 Clinical outcome comparisons 20 1. 1.6.2 Cost comparisons 2t 1. 1.6-3 Randomised comparisons 22 T.1.7 RE-OPERATTVE SURGERY FOLLOWING LAPAROSCOPIC FUNDOPLICATION 22 1.1.8 RANDOMISED TRIALS FOR LAPAROSCOPIC SURGERY 23 v 1.1.9 CONTROVERSIES AND DISAGREEMENTS 24 1.1 .9.1 Laparoscopic partial fundoplication 25 1.1 .9.2 Laparoscopic division of the short gastric vessels 25 1.1 .9.3 Selective versus routine hiatal repair 27 1.1 .9.4 The tailored approach to laparoscopic fundoplication 27 1.1 .9.5 The short oesophagus 28 1.1.10 FUTURE DIRECTIONS 29 1.1.11 RESEARCH OVERVIEW AND AIMS 29 1.2 OUTCOME OF PROSPECTIVE STUDIES ASSESSING OUTCOMES FOLLOWING LAPAROSCOPIC ANTIREFLUX SURGERY 31 T.2.T AIMS 31 T.2.2 GENERALMETHODOLOGY 31 I.2.2.I Preoperative assessment 31 1.2.2.2 Surgical technique for laparoscopic Nissen fundoplication 32 1.2.2.3 Post-operative management 36 I.2-2.4 Data management and follow-up protocol 36 1.2.3 INITIAL OUTCOME ASSESSMENT OF PROSPECTTVE CASE SERIES 37 1.2.3.1 Initial outcomes - the first 70 patients 37 1.2.3.1.I Patients and methods 37 1.2.3.I.2 Results 38 1.2.3.1.3 Discussion 43 1.2.3.2 Experience with 230laparoscopic antireflux operations and resulting changing surgical strategies 45 L.2.3.2-I Patients and methods 45 1.2.3.2.2 Results 46 I.2.3.2.3 Discussion 50 t.2.4 UNIQUE COMPLICATIONS OF LAPAROSCOPIC FUNDOPLICATION 52 I.2.4.1 Pneumothorax 52 I.2.4.1.I Case reports 53 I.2.4.1.2 Discussion 54 1.2.4.2 Para-oesophageal hiatus hernia 56 I.2.4.2-I Patients and methods 56 1.2.4.2.2 Results 56 I.2.4.2.3 Discussion 58 L.2.4.3 Stenosis of the oesophageal hiatus 60 1.2.4.3.I Report of cases 60 I.2.4.3.2 Discussion 63 T.2.5 THE LEARNING CURVE FOR LAPAROSCOPIC FUNDOPLICATION 65 1.2.5-l Defining the learning curve for laparoscopic fundoplication 65 I.2.5.1.1 Methods 65 1.2.5.1.2 Results 67 1.2.5.I.3 Discussion 76 1.2.5.2 Experience with laparoscopic surgery for gastro-oesophageal reflux beyond the leaming curve 78 1.2.5-2.I Patients and methods 79 L.2.5.2.2 Results 79 I.2.5.2.3 Discussion 82 V1 T.2.6 SHOULD THE CHOICE OF PROCEDURE FOR REFLUX BE INFLUENCED BY PREOPERATIVE PATHOLOGY? 83 1.2.6.1 Preoperative endoscopic grading of oesophagitis versus outcome 83 1.2.6.1.I Patients and methods 84 1.2.6.I.2 Results 86 I.2.6.1.3 Discussion 89 I.2.6.2 Oesophageal motility parameters before and after laparoscopic Nissen fundoplication 9l 1.2.6.2.1 Methods 92 I.2 -6.2.I.1 Patient selection 92 l -2.6.2.1.2 Oesophageal Manometry 92 I.2.6.2.1.3 Data analysis 93 1.2.6.2.1.4 Clinical outcome scores 95 1.2.6.2.1.5 Statistical analysis 95 I.2.6.2.2 Results 95 1.2.6.2.3 Discussion 99 1.2.6.3 The outcome of laparoscopic Nissen fundoplication in patients with disordered pre-operative peristalsis r02 I.2.6.3.I Patients and methods t02 I.2.6.3.1.1 Manometry 102 I.2.6.3.1.2 Patients 103 1.2.6.3.1.3 Follow-uP 103 1.2.6.3.2 Results 103 I.2.6.3.3 Discussion 109 1.2.6.4 Illness behaviour versus outcome following laparoscopic antireflux surgery 110 I.2.6.4.1 Methods 111 I.2.6.4.I J Illness Behaviour Questionnaire 111 1.2.6.4.1.2 Clinical Follow-uP 113 1.2.6.4.1.3 Statistical Analysis 113 7.2.6.4.2 Results IT3 I.2.6.4.3 Discussion 118 1.2.7 CONCLUSIONS t19 2 LABORATORY RESEARCH 122 2.1 coMPARrsoN oF ANTERTOR, POSTERTOR AND TOTAL FUNDOPLICATION USING A VISCERA MODEL 123 2.1.1 ArM 123 2.1.2 MATERIALS AND METHODS 123 2.1..2.1 Baseline study t26 2.I.2.2 Parameters following oesophageal myotomy t26 2-1.2.3 Parameters following anterior hemi-fundoplication t26 2.1,.2.4 Parameters following posterior hemi-fundoplication 126 2.1.2.5 Parameters following total fundoplication r27 2.I.2.6 Statistics t2l 2.T.3 RESULTS r2'7 2.1.4 DISCUSSION t29 v11 2.2 EFFTCACY OF ANTERTOR, POSTERTOR AND TOTAL FUNDOPLICATION IN A PORCINE MODEL 132 2.2.1 AIM t32 2.2.2 MATERIALS AND METHODS r32 2.2-2.I General Operative Procedure t33 2.2.2.2 Anterior fundoPlication 135 2.2-2.3 Posterior fundoplication 136 2.2.2.4 Total fundoplication 136 2.2.2.5 Postoperative care 136 2.2.2.6 Postoperative studies r37 2.2.2.7 Statistics r37 2.2.2.8 Ethics 138 2.2.3 RESULTS 138 2.2.4 DISCUSSION 140 3 CONTROLLED TRIALS ASSESSING STRATEGIES TO IMPROVE OUTCOMES FOLLOWING SURGERY FOR GASTRO- OESOPHAGEAL REFLUX L46 3.1 PROSPECTIVE RANDOMISED TRIAL OF LAPAROSCOPIC VERSUS OPEN NISSEN FUNDOPLICATION FOR GASTRO. OESOPTIAGEAL REFLUX DISEASE 147 3.1.1 AIMS 147 3 1 .2 METHODS t47 3.1 .2.I Participant assignment r47 3.L .2.2 Patient selection and pre-operative assessment 148 3.1 .2.3 Operating technique 148 3.1 .2.4 Post-operative care 1,49 3.r .2.5 Masking t49 3.1 .2.6 Clinical follow-up r49 3.L.2.7 Objective follow-up 151 3-1.2.1 I Oesophageal manometrY 151 3.1.2.7.2 Ambulatory 24hr pH monitoring r52 3.1.2.7.3 Upper gastrointestinal endoscopy r52 3.I.2.8 Statistical analysis r52 3.I.2.9 Ethical approval 153 3.7.3 RESULTS t53 3.1.3.1 Pre-operative assessment r53 3.1 .3.2 Surgery 158 3.1 .3.3 Early hospital outcomes 158 3.1 .3.4 Late hospital outcomes 160 3.1 .3.5 Clinical outcome assessment 160 3.r 3.6 Objective post-operative investigations 161 3.1.4 DISCUSSION t62 v111 3.2 PROSPECTIVE DOUBLE BLIND RANDOMISED TRIAL OF LAPAROSCOPIC NISSEN FUNDOPLICATION WITH DIVISION AND WITHOUT DIVISION OF SHORT GASTRIC VESSELS 166 3.2.1 AIM r66 3.2.2 METHODS 166 3.2.2.I Participant assignment r66 3-2.2.2 Patienf selection and preoperative investigation t67 3.2.2.3 Operating technique r67 3.2.2-4 Post-operative care 168 3.2.2.5 Masking 168 3.2.2.6 Clinical follow-up r69 3.2.2.7 Objective follow-uP r7l 3.2.2.7.I Oesophageal ManometrY t7r 3.2.2.7.2 Ambulatory 24hout pH monitoring r72 3.2.2.7.3 Radionuclide Oesophageal Emptying Study t72 3.2.2.7.4 Barium Swallow examination 772 3.2.2.8 Statistical analysis t72 3.2.2.9 Ethical approval r73 3.2.3 RESULTS r74 3.2.3.1 Preoperative assessment 175 3.2.3.2 Surgery r82 3.2.3.3 Early hospital outcomes 183 3.2.3.4 One to six month post-operative clinical outcome 185 3.2.3.5 Objective post-operative investigations 186 3.2.4 DISCUSSION r87 3.3 PROSPECTIVE DOUBLE BLIND RANDOMISED TRIAL OF LAPAROSCOPIC ANTERIOR PARTIAL VERSUS NISSEN FUNDOPLICATION 191 3.3.1 AIMS 191 3.3.2 METHODS 191 3.3.2.1 Participant assignment 191 3 -3.2.2 Patient selection and preoperative investigation 191 3.3.2.3 Operating technique t92 3.3.2.4 Post-operative care t93 3.3.2.5 Masking 193 3.3.2.6 Clinical follow-up 193 3.3.2.7 Objective follow-uP 194 3.3.2.7.1 Oesophageal ManometrY t94 3.3.2.7.2 Ambulatory 24hour pH monitoring 194 3.3.2.7.3 Radionuclide Oesophageal Emptying Study 194 3.3-2.7.4 Upper Gastrointestinal Endoscopy 194 3.3.2.8 Statistical analysis 195 3.3.2.9 Ethical approval 196 3.3.3 RESULTS 196 3.3 3.1 Preoperative assessment r97 3.3 3.2 Surgery 204 3.3 3.3 Early hospital outcomes 206 3.3 3.4 One to six month post-operative clinical outcome 207 3.3 3.5 Objective post-operative investigations 209 3.3.4 DISCUSSION 2t0 1X 4 CONCLUSIONS 2L4 4.I IS LAPAROSCOPIC ANTIREFLUX SURGERY ADVANTAGEOUS? 215 4.1.1 Outcome of case series studies 215 4.1.2 Prospective randomised trials of laparoscopic versus open Nissen fundoplication 216 4.2 SHORT GASTRIC VESSELS 218 4.3 NISSEN VERSUS PARTIAL FUNDOPLICATION 220 4.3.1 Uncontrolledstudies 220 4.3-Z Experimentalmodels 220 4.3.3 A role for patients with oesophageal dysmotility 22I 4.3.4 Prospective randomised trials of Nissen versus partial fundoplication 22r 4.4 IMPLICATIONS 223 4.5 FUTURE DIRECTIONS 223 5 BIBLIOGRAPHY 227 6 APPENDIX 256 X ABSTRACT The advent of laparoscopic surgical techniques has refocussed the medical community's interest in surgery for gastro-oesophageal reflux disease.
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