Prospective Randomized Trial of Laparoscopic Nissen Fundoplication With Anterior Versus Posterior Hiatal Repair: Late Outcomes.
Summary of "Prospective Randomized Trial of Laparoscopic Nissen Fundoplication With Anterior Versus Posterior Hiatal Repair: Late Outcomes."
The technique used for hiatal closure in laparoscopic Nissen fundoplication might have an impact on the risk of postfundoplication dysphagia and hiatal herniation. In 1997, we commenced a randomized trial to evaluate the impact of anterior versus posterior hiatal repair techniques on these outcomes. In the present study, we evaluated the 10-year outcomes from this trial.
A total of 102 patients were randomized to undergo laparoscopic Nissen fundoplication with either anterior (47 patients) or posterior (55 patients) repair of the diaphragmatic hiatus. Outcomes were assessed using standardized clinical assessment scores that evaluated reflux symptoms, dysphagia, and satisfaction with the outcome following surgery.
Clinical outcomes 10 years after surgery were available for 93% of patients, and outcome scores were obtained for 43 patients in each group. Patients undergoing anterior hiatal repair were less likely to report dysphagia for lumpy solid foods (14.0% vs. 39.5%, p = 0.01), although there were no significant differences in dysphagia outcomes for six other dysphagia assessment scores. There were no differences between the two groups for reflux symptoms, medication use, and overall satisfaction with the outcome of surgery.
At the 10-year follow-up, the outcomes for the two groups were similar. Anterior hiatal repair is an acceptable technique for hiatal closure during laparoscopic Nissen fundoplication.
Flinders University Department of Surgery, Flinders Medical Centre, Room 3D211, Bedford Park, SA, 5042, Australia.
This article was published in the following journal.
Name: World journal of surgery
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/21713577
- DOI: http://dx.doi.org/10.1007/s00268-011-1172-x
Medical and Biotech [MESH] Definitions
Randomized Controlled Trial
Work consisting of a clinical trial that involves at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.
Controlled Clinical Trial
Work consisting of a clinical trial involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicine, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trial is characterized as a RANDOMIZED CONTROLLED TRIAL.
Prospective Payment Assessment Commission
The commission charged with evaluating issues and factors which affect the implementation of the PROSPECTIVE PAYMENT SYSTEM.
Compassionate Use Trials
Providing an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for which other treatments are not available. Compassionate use trials allow patients to receive promising but not yet fully studied or approved therapies when no other treatment option exists. Also called expanded access trial.
Mobilization of the lower end of the esophagus and plication of the fundus of the stomach around it (fundic wrapping) in the treatment of GASTROESOPHAGEAL REFLUX that may be associated with various disorders, such as hiatal hernia. (From Dorland, 28th ed)
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