Markku Luostarinen, Juha Virtanen, Tiit Koobi, Matti Koskinen, Tuula Tyrvainen, Tuoma Rantanen, Martti Matikainen, Jouko Isolauri, Paijat-Hame Central Hospital, Lahti, Finland, Tampere University Hospital, Tampere, Finland, Ministry of Social Affairs and Health, Helsinki, Finland

Background: Postoperative dysphagia seems to be more common after laparoscopic than open fundoplication. This is reflected in disturbance of esophageal clearance, shown by esophageal radionuclide transit. If dysphagia leads to repeated dilatations or even reoperation, the advantages of laparoscopic procedure are vanished. Some disturbance in LES/fundic wrap relaxation is, however, essential to anti-reflux function of fundoplication. Hypothesis: Although the main antireflux mechanism of fundoplication may be one-way flap function, fundic wrap has also features of a sphincter. Botox injected to the wrap may decrease pressure on the lower esophageal sphincter region and facilitate deglutitive relaxation and decrease resistance to bolus transport, an analogy with Botox in treatment of achalasia. Because of one-way flap function, Botox injection should not induce reflux. Patients and methods: 15 consecutive patients with confirmed GERD and normal esophageal motility received in randomized double-blind manner at the end of laparoscopic fundoplication 4 boluses of 20 IU Botox (5 patients) or same volume of NaCl (10 patients) into their wraps through retroflexed endoscope. Esophageal clearance was measured by liquid bolus radionuclide transit preoperatively and 3, 30 and 90 days after fundoplication. Results: Symptoms and signs of reflux were abolished in all. Esophageal clearance was disturbed during the follow-up in 6/10 of the patients of the NaCl group, compared to 1/5 of the Botox-group. 90% appearing time of acticity to the stomach (in seconds, upper normal limit 11.5) was preoperatively 4.9 (SD 0.96), on 3h postoperative day 7.4 (SD 2.3), on 30th postoperative day 8.4 (SD 3.1) and on 90th postoperative day 5.9 (SD 1.43) in Botox-group, compared to 7.0 (SD 2.9), 17.8 (SD 21.7), 9.0 (SD 3.1) and 19.0 (SD 18.9) in NaCl-group, respectively. Conclusion: Injection of Botox to fundic wrap has observable effect in normalizing esophageal clearance during early postfundoplication period.