BACKGROUND:Laparoscopic Nissen fundoplication (LNF) has become established as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease (GERD). Postoperative paraesophageal herniation has an incidence range up to 7% in the immediate postoperative period. AIM: A prospective randomized trial was scheduled to study the role of posterior gastropexy, in combination with LNF, in prevention of paraesophageal herniation and improvement of postoperative results in surgical treatment of GERD. PATIENTS AND METHODS: Eighty-two patients with GERD were randomized to LNF combined with (group A, n = 40) or without (group B, n = 42) posterior gastropexy. Subjective evaluation using disease-specific and generic questionnaires and structured interviews, and objective evaluation by endoscopy, esophageal manometry, and 24-h pH monitoring, were performed before operation, at 2 and 12 months after surgery, and then every year. Crura approximation was performed by stitches if the diameter was less than 6 cm, or with a patch to reinforce the conventional crural closure or by tension-free technique to close the hiatus. Posterior gastropexy (group A) was performed with one stitch between the posterior wall of the wrap and the crura near the arcuate ligament. RESULTS:Sixteen patients of group A and 15 patients of group B with concomitant abdominal diseases had simultaneous procedures [cholecystectomy 25, vagotomy 2, ventral hernia repair 1, gastric polypectomy 1, gastric fundus diverticulectomy 1, gastrointestinal stromal tumor (GIST) wedge resection 1]. In mean follow-up of 48 +/- 26 months (range 7-94 months), one patient of group B presented with paraesophageal herniation in the first postoperative month (reoperation), while recurrent gastroesophageal reflux (Visick III or IV), successfully treated by medication, was noted in three patients of group B and in one patient of group A. Only mild dysphagia, during the first two postoperative months, was noted in nine patients of group A and eight patients of group B. Six patients of each group with Barrett's esophagus had endoscopic improvement after the second postoperative month. Visick score in groups A/B was I in 26/11 (P < 0.0001), II in 13/27 (P = 0.037), III in 1/2 (not significant, NS), and IV in 0/2. Generally, Visick score was I or II in 39/38 in groups A/B (97.5%/90.5%, NS) and III or IV in 1/4 (2.5%/9.5%, P < 0.0001). CONCLUSIONS:LNF combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD, providing better early and long-term postoperative results. (Registered Clinical Trial number: NCT00872755. www.clinicaltrials.gov .).
RCT Entities:
BACKGROUND: Laparoscopic Nissen fundoplication (LNF) has become established as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease (GERD). Postoperative paraesophageal herniation has an incidence range up to 7% in the immediate postoperative period. AIM: A prospective randomized trial was scheduled to study the role of posterior gastropexy, in combination with LNF, in prevention of paraesophageal herniation and improvement of postoperative results in surgical treatment of GERD. PATIENTS AND METHODS: Eighty-two patients with GERD were randomized to LNF combined with (group A, n = 40) or without (group B, n = 42) posterior gastropexy. Subjective evaluation using disease-specific and generic questionnaires and structured interviews, and objective evaluation by endoscopy, esophageal manometry, and 24-h pH monitoring, were performed before operation, at 2 and 12 months after surgery, and then every year. Crura approximation was performed by stitches if the diameter was less than 6 cm, or with a patch to reinforce the conventional crural closure or by tension-free technique to close the hiatus. Posterior gastropexy (group A) was performed with one stitch between the posterior wall of the wrap and the crura near the arcuate ligament. RESULTS: Sixteen patients of group A and 15 patients of group B with concomitant abdominal diseases had simultaneous procedures [cholecystectomy 25, vagotomy 2, ventral hernia repair 1, gastric polypectomy 1, gastric fundus diverticulectomy 1, gastrointestinal stromal tumor (GIST) wedge resection 1]. In mean follow-up of 48 +/- 26 months (range 7-94 months), one patient of group B presented with paraesophageal herniation in the first postoperative month (reoperation), while recurrent gastroesophageal reflux (Visick III or IV), successfully treated by medication, was noted in three patients of group B and in one patient of group A. Only mild dysphagia, during the first two postoperative months, was noted in nine patients of group A and eight patients of group B. Six patients of each group with Barrett's esophagus had endoscopic improvement after the second postoperative month. Visick score in groups A/B was I in 26/11 (P < 0.0001), II in 13/27 (P = 0.037), III in 1/2 (not significant, NS), and IV in 0/2. Generally, Visick score was I or II in 39/38 in groups A/B (97.5%/90.5%, NS) and III or IV in 1/4 (2.5%/9.5%, P < 0.0001). CONCLUSIONS: LNF combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD, providing better early and long-term postoperative results. (Registered Clinical Trial number: NCT00872755. www.clinicaltrials.gov .).