Dataset Information

Multicenter Prospective Study of Laparoscopic Nissen Fundoplication for Gastroesophageal Reflux Disease in Korea.

ABSTRACT:

Backgrounds/aims

This multicenter study aims to evaluate the effect and feasibility of anti-reflux surgery compared with medical treatment for gastroesophageal reflux disease (GERD).

Methods

Patients with GERD who were undergoing medical treatment with proton pump inhibitors for more than 8 weeks and those who were scheduled to undergo anti-reflux surgery were enrolled. Efficacy of pre-operative medical treatment was evaluated retrospectively and effect of anti-reflux surgery was prospectively evaluated at 1 week and 3 months after surgery. Quality of life (QOL) was also investigated before and after surgery.

Results

Between February and October 2018, 51 patients underwent laparoscopic Nissen fundoplication for treating GERD at 5 hospitals in Korea. Thirty-four patients (66.7%) showed poor proton pump inhibitor response. At 3 months after surgery, heartburn was completely resolved in 87.9% patients and partially improved in 9.1%. Acid regurgitation was completely resolved in 82.9% and partially improved in 11.4%. Atypical extraesophageal symptoms were completely controlled in 45.5% and partially controlled in 36.4%. GERD-related QOL scores at 1 week after surgery significantly improved compared with pre-operative scores. There was no difference in GERD-related QOL scores between 1 week and 3 months after surgery. General QOL measured with European QOL-5 dimensions and health-related QOL instrument with 8 items significantly improved after anti-reflux surgery. Satisfaction with treatment was significantly higher after surgery than before surgery (72.5% vs 11.8%, P < 0.001).

Conclusion

Anti-reflux surgery improved GERD symptoms and QOL in patients. Anti-reflux surgery is an effective treatment option compared with medical treatment for GERD patients selected for surgical treatment.

SUBMITTER: Park S

PROVIDER: S-EPMC6657928 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionLaparoscopic fundoplication is the gold standard treatment for gastroesophageal reflux disease (GERD) refractory to medical management. Although many studies have compared Nissen fundoplication (NF) to Toupet fundoplication (TF), it is unclear which operation provides the best long-term reflux control. The objective of this study was to evaluate long-term quality-of-life (QoL) outcomes after NF versus TF.MethodsClinical data from our single academic institutional foregut database were used to identify patients who underwent NF or TF (June 2010 to May 2016). Postoperative QoL was assessed through telephone at 1, 3, or 5 years postsurgery, using GERD-health related quality of life (GERD-HRQL), Gastroparesis Cardinal Symptom Index (GCSI), and Eckardt Dysphagia scores. Proton pump inhibitor (PPI) use and satisfaction with surgery were also obtained. Trends in outcomes over time were analyzed by logistic regression or Cochran-Armitage trend test.ResultsOur cohort included 155 TF and 161 NF patients. TF patients reported baseline dysphagia at higher rates (42.6% versus 19.9%; P < .001) and had worse preoperative esophageal dysmotility than NF patients. There were no significant differences in GERD-HRQL or GCSI scores between TF and NF patients at any time point postoperatively. Long-term satisfaction was equivalent between TF and NF patients 5 years postoperatively (70.0% versus 77.4%; P = .67). NF patients had higher Eckardt dysphagia scores 1 year after surgery compared to TF patients, but this difference was not present at 3 or 5 years postoperatively. Over time, PPI use increased and there was a trend toward increased GERD-HRQL scores in the TF group.ConclusionsBoth TF and NF provide excellent long-term satisfaction for patients with GERD. NF and TF patients reported similar postoperative QoL scores. Our finding of increasing PPI use and a trend toward worsening GERD scores following TF warrants additional investigation regarding the long-term durability of TF.

Project description:Importance:Restoration of the esophagogastric junction competence is critical for effective long-term treatment of gastroesophageal reflux disease. Surgical repair results in such restoration, but mechanical adverse effects seem unavoidable. Minimizing these adverse effects without jeopardizing reflux control is warranted. Objective:To determine whether partial fundoplication (PF) or total fundoplication (TF) is superior in laparoscopic antireflux surgery. Design, Setting, and Participants:In this double-blind, randomized clinical trial of 1171 patients scheduled for laparoscopic antireflux surgery at a single university-affiliated center between November 19, 2001, and January 24, 2006, 456 patients were randomized and followed up for 5 years. Data were collected from November 2001 to April 2012, and data were analyzed from April 2012 to September 2018. Interventions:A 270° posterior PF or a 360° Nissen TF. Main Outcomes and Measures:Esophageal acid exposure at 3 years after surgery. Result:Of the 456 randomized patients, 268 (58.8%) were male, and the mean (SD) age was 49.0 (11.7) years. A total of 229 patients were randomized to PF, and 227 patients were randomized to TF. At 3 years postoperatively, the median (interquartile range) esophageal acid exposure was reduced from 14.6% (9.8-21.9) to 1.8% (0.7-4.4) after PF and from 16.0% (10.4-22.7) to 2.5% (0.8-6.8) after TF (P = .31). Likewise, reflux symptoms were equally and effectively controlled. Early postoperative dysphagia (6 weeks) was common in both groups but then decreased toward normality. A small but statistically significant difference in favor of PF was noted in the mean (SD) scoring of dysphagia for liquids at 6 weeks (PF, 1.6 [0.9]; TF, 1.9 [1.3]; P = .01) and for solid food at 12 months (PF, 1.3 [1.0]; TF, 1.9 [1.4]; P < .001) and 24 months (PF, 1.3 [0.9]; TF, 1.7 [1.2]; P = .001). Quality of life was reduced before surgery but increased to normal values after surgery and remained so over 5-year follow-up, with no difference between the groups. Conclusions and Relevance:The results from this randomized clinical trial suggest that although PF and TF could be recommended for treatment of gastroesophageal reflux disease, PF might be superior by inducing less dysphagia. Trial Registration:ClinicalTrials.gov identifier: NCT03659487.

Project description:ImportanceThe efficacy of fundoplication operations in the management of gastroesophageal reflux disease (GERD) has been documented. However, few prospective, controlled series report long-term (>10 years) efficacy and postfundoplication concerns, particularly when comparing various types of fundoplication.ObjectiveTo compare long-term (>15 years) results regarding mechanical complications, reflux control, and quality of life between patients undergoing posterior partial fundoplication (PF) or total fundoplication (TF) (270° vs 360°) in surgical treatment for GERD.Design, setting, and participantsA double-blind randomized clinical trial was performed at a single center (Ersta Hospital, Stockholm, Sweden) from November 19, 2001, to January 24, 2006. A total of 456 patients were recruited and randomized. Data for this analysis were collected from August 1, 2019, to January 31, 2021.InterventionsLaparoscopic 270° posterior PF vs 360° TF.Main outcomes and measuresThe main outcome was dysphagia scores for solid and liquid food items after more than 15 years. Generic (36-Item Short-Form Health Survey) and disease-specific (Gastrointestinal Symptom Rating Scale) quality of life and proton pump inhibitor consumption were also assessed.ResultsAmong 407 available patients, relevant data were obtained from 310 (response rate, 76%; mean [SD] age, 66 [11.2] years; 184 [59%] men). A total of 159 were allocated to a PF and 151 to a TF. The mean (SD) follow-up time was 16 (1.3) years. At 15 years after surgery, mean (SD) dysphagia scores were low for both liquids (PF, 1.2 [0.5]; TF, 1.2 [0.5]; P = .58) and solids (PF, 1.3 [0.6]; TF, 1.3 [0.5]; P = .97), without statistically significant differences between the groups. Reflux symptoms were equally well controlled by the 2 types of fundoplications as were the improvements of quality-of-life scores.Conclusions and relevanceThe long-term findings of this randomized clinical trial indicate that PF and TF are equally effective for controlling GERD and quality of life in the long term. Although PF was superior in the first years after surgery in terms of less dysphagia recorded, this difference did not prevail when assessed a decade later.Trial registrationClinicalTrials.gov Identifier: NCT04182178.