ArticleAnnals of translational medicine2021
Laparoscopic total left-sided surgical approach versus traditional bilateral surgical approach for treating hiatal hernia: a study protocol for a randomized controlled trial.
Article in Annals of translational medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed, 7 citations in OpenAlex.
- Application of Intravenous Anesthesia in Laparoscopic Hiatal Hernia Repair of Children.Contrast media & molecular imaging · 2022Trial
- A new technique for treating hiatal hernia with gastroesophageal reflux disease: the laparoscopic total left-side surgical approach.BMC surgery · 2021Trial
- Modified laparoscopic Toupet fundoplication with vagus nerve sparing via total left-side approach for hiatal hernia with gastroesophageal reflux disease: a pilot study.Translational gastroenterology and hepatology · 2026Article
- Innovative laparoscopic 'Tunnel' approach in managing hiatal hernia with gastroesophageal reflux disease: a retrospective study.BMC surgery · 2025Article
- Current Advancement on the Dynamic Mechanism of Gastroesophageal Reflux Disease.International journal of biological sciences · 2021Review
Corrections and comments
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Authors and funding
13 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn China, guidelines for the treatment of hiatal hernia (HH) are lacking. Furthermore, efficacy and safety assessments of surgical approaches for HH and for the protection of the vagus nerve and organ function are needed. Therefore, the present clinical trial is being conducted to establish the normative treatment for HH.
methodsThe current trial is an ongoing, single-center, randomized controlled trial of patients with HH. The total sample size required for the trial (July 2020-December 2023) is approximately 114 patients. Patients will be randomly assigned to either an experimental group (total left-sided surgical approach; TLSA) or a control group (traditional bilateral surgical approach; TBSA) at a ratio of 1:1 using the block randomization method. We will use case report forms (CRFs) and electronic data capture (EDC) systems to obtain demographic information, preoperative laboratory tests, auxiliary examination results, operation information, and postoperative condition. The patients will be followed up for 3 years after surgery. The primary endpoint is the gastrointestinal quality-of-life index (GIQLI) at 1 year. The secondary endpoints include an efficacy evaluation index [consisting of the incidence of gallstones and gastric emptying disorders, gastrointestinal function recovery time, visual analog scale (VAS) scores, objective evaluation of postoperative indices, and surgical information] and a safety evaluation index (consisting of the incidence of postoperative complications, the 30-day postoperative mortality rate, and the HH recurrence rate at 1 and 3 years after surgery). DISCUSSION: TLSA can protect the normal physiological function of organs to a certain extent by protecting the vagus nerve from injury, and has satisfactory short- and long-term efficacy. There is no significant difference in the incidence of postoperative complications and surgical safety between TLSA and TBSA. Our findings will facilitate clinical decision-making for HH and improve the life quality of patients.
trial registrationChinese Clinical Trial Registry, ChiCTR2000034028 (registration date: June 21, 2020).
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