Dataset Information

Clinical Outcomes of a Laparoscopic Total vs a 270° Posterior Partial Fundoplication in Chronic Gastroesophageal Reflux Disease: A Randomized Clinical Trial.

ABSTRACT:

Importance

The 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.

Objective

To 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 participants

A 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.

Interventions

Laparoscopic 270° posterior PF vs 360° TF.

Main outcomes and measures

The 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.

Results

Among 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 relevance

The 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 registration

ClinicalTrials.gov Identifier: NCT04182178.

SUBMITTER: Analatos A

PROVIDER: S-EPMC9021984 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Clinical Outcomes of a Laparoscopic Total vs a 270° Posterior Partial Fundoplication in Chronic Gastroesophageal Reflux Disease: A Randomized Clinical Trial.

Analatos Apostolos A Håkanson Bengt S BS Ansorge Christoph C Lindblad Mats M Lundell Lars L Thorell Anders A

JAMA surgery 20220601 6

<h4>Importance</h4>The 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.<h4>Objective</h4>To compare long-term (>15 years) results regarding mechanical complications, reflux control, and quality of life between patients undergoing posterior partial fundop ...[more]

PMID: 35442430

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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:BackgroundFundoplication is an essential step in para-oesophageal hernia (POH) repair, but which type minimizes postoperative mechanical complications is controversial.MethodsThis was a randomized, double-blind clinical trial conducted between May 2009 and October 2018. Patients with symptomatic POH were allocated to either a total (Nissen) or a posterior partial (Toupet) fundoplication after hernia reduction and crural repair. The primary outcome was dysphagia (Ogilvie dysphagia scores) at 6 months postoperatively. Secondary outcomes were peri- and postoperative complications, swallowing difficulties assessed by the Dakkak dysphagia score, gastro-oesophageal reflux, quality of life (QoL), and radiologically confirmed hernia recurrence.ResultsA total of 70 patients were randomized to a Nissen (n = 32) or a Toupet (n = 38) fundoplication. Compared with baseline, Ogilvie dysphagia scores were stable at the 3- and 6-month follow-up in the Nissen group (P = 0.075 and 0.084 respectively) but significantly improved in the Toupet group (from baseline mean (s.d.): 1.4 (1.1) to 0.5 ( 0.8) at 3 months, and 0.5 (0.6) at 6 months; P = 0.003 and P = 0.001 respectively). At 6 months, Dakkak dysphagia scores were significantly higher in the Nissen group than in the Toupet group (mean (s.d.): 10.4 (7.9) versus 5.1 (7.2); P = 0.003). QoL scores improved throughout the follow-up. However, at 3 and 6 months postoperatively, the absolute median improvement (⍙) from preoperative values in the mental component scores of the Short Form-36 QoL questionnaire was significantly higher in the Toupet group (median (i.q.r.): 7.1 (-0.6 to 15.2) versus 1.0 (-5.4 to 3.3) at 3 months, and 11.2 (1.4 to 18.3) versus 0.4 (-9.4 to 7.5) at 6 months; (P = 0.010 and 0.003 respectively)). At 6 months, radiologically confirmed POH recurrence occurred in 11 of 24 patients (46 per cent) of the Nissen group and in 15 of 32 patients (47 per cent) of the Toupet group (P = 1.001).ConclusionsA partial posterior wrap (Toupet fundoplication) showed reduced obstructive complications and improved QoL compared with a total (Nissen) fundoplication following POH repair.Registration number: NCT04436159 (http://www.clinicaltrials.gov).

Project description:BackgroundLaparoscopic Nissen fundoplication (LNF) is the most common standard technique worldwidely for Gastroesophageal reflux disease (GERD). Another type of fundoplication, laparoscopic Toupet fundoplication (LTF), intends to reduce incidence of postoperative complications. A systematic review and meta-analysis are required on short- and long-term outcomes based on randomized controlled trials (RCTs) between LNF and LTF.MethodsWe searched databases including PubMed, Cochrane, Embase, and Web of Knowledge for RCTs comparing LNF and LTF. Outcomes included postoperative reflux recurrence, postoperative heartburn, dysphagia and postoperative chest pain, inability to belch, gas bloating, satisfaction with intervention, postoperative esophagitis, postoperative DeMeester scores, operating time (min), in-hospital complications, postoperative use of proton pump inhibitors, reoperation rate, postoperative lower oesophageal sphincter (LOS) pressure (mmHg). We assessed data using risk ratios and weighted mean differences in meta-analyses.ResultsEight eligible RCTs comparing LNF (n = 605) and LTF (n = 607) were identified. There were no significant differences between the LNF and LTF in terms of postoperative reflux recurrence, postoperative heartburn, postoperative chest pain, satisfaction with intervention, reoperation rate in short and long term, in-hospital complications, esophagitis in short term, and gas bloating, postoperative DeMeester scores, postoperative use of proton pump inhibitors, reoperation rate in long term. LTF had lower LOS pressure (mmHg), fewer postoperative dysphagia and inability to belch in short and long term and gas bloating in short term compared to LNF.ConclusionLTF were equally effective at controlling reflux symptoms and improving the quality of life, but with lower rate of complications compared to LNF. We concluded that LTF surgical treatment was superior for over 16 years old patients with typical symptoms of GERD and without upper abdominal surgical history upon high-level evidence of evidence-based medicine.

Project description:ImportanceCohort studies, mainly based on questionnaires and interviews, have reported high rates of reflux recurrence after antireflux surgery, which may have contributed to a decline in its use. Reflux recurrence after laparoscopic antireflux surgery has not been assessed in a long-term population-based study of unselected patients.ObjectivesTo determine the risk of reflux recurrence after laparoscopic antireflux surgery and to identify risk factors for recurrence.Design and settingNationwide population-based retrospective cohort study in Sweden between January 1, 2005, and December 31, 2014, based on all Swedish health care and including 2655 patients who underwent laparoscopic antireflux surgery according to the Swedish Patient Registry. Their records were linked to the Swedish Causes of Death Registry and Prescribed Drug Registry.ExposuresPrimary laparoscopic antireflux surgery due to gastroesophageal reflux disease in adults (>18 years).Main outcomes and measuresThe outcome was recurrence of reflux, defined as use of antireflux medication (proton pump inhibitors or histamine2 receptor antagonists for >6 months) or secondary antireflux surgery. Multivariable Cox regression was used to assess risk factors for reflux recurrence.ResultsAmong all 2655 patients who underwent antireflux surgery (median age, 51.0 years; interquartile range, 40.0-61.0 years; 1354 men [51.0%]) and were followed up for a median of 5.6 years, 470 patients (17.7%) had reflux recurrence; 393 (83.6%) received long-term antireflux medication and 77 (16.4%) underwent secondary antireflux surgery. Risk factors for reflux recurrence included female sex (hazard ratio [HR], 1.57 [95% CI, 1.29-1.90]; 286 of 1301 women [22.0%] and 184 of 1354 men [13.6%] had recurrence of reflux), older age (HR, 1.41 [95% CI, 1.10-1.81] for age ≥61 years compared with ≤45 years; recurrence among 156 of 715 patients and 133 of 989 patients, respectively), and comorbidity (HR, 1.36 [95% CI, 1.13-1.65] for Charlson comorbidity index score ≥1 compared with 0; recurrence among 180 of 804 patients and 290 of 1851 patients, respectively). Hospital volume of antireflux surgery was not associated with risk of reflux recurrence (HR, 1.09 [95% CI, 0.77-1.53] for hospital volume ≤24 surgeries compared with ≥76 surgeries; recurrence among 38 of 266 patients [14.3%] and 271 of 1526 patients [17.8%], respectively).Conclusions and relevanceAmong patients who underwent primary laparoscopic antireflux surgery, 17.7% experienced recurrent gastroesophageal reflux requiring long-term medication use or secondary antireflux surgery. Risk factors for recurrence were older age, female sex, and comorbidity. Laparoscopic antireflux surgery was associated with a relatively high rate of recurrent gastroesophageal reflux disease requiring treatment, diminishing some of the benefits of the operation.

Dataset Information

Clinical Outcomes of a Laparoscopic Total vs a 270° Posterior Partial Fundoplication in Chronic Gastroesophageal Reflux Disease: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Clinical Outcomes of a Laparoscopic Total vs a 270° Posterior Partial Fundoplication in Chronic Gastroesophageal Reflux Disease: A Randomized Clinical Trial.

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