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临床试验/NCT07387042
NCT07387042
尚未招募
不适用

Comparison of Laparoscopic Nissen Fundoplication and Hill-Snow Repair for Hiatus Hernia With Endoscopic Evaluation: Randomized Controlled Trial

Minia University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年3月1日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Minia University
入组人数
40
试验地点
1
主要终点
Degree of relief of GERD symptoms assessed by GERD Health-Related Quality Of Life (GERD-HRQL) score

概览

简要总结

The goal of this clinical trial is to compare the clinical efficacy and safety of laparoscopic Nissen fundoplication (LNF) versus laparoscopic Hill-Snow repair (LHS) in the management of patients with congenital hiatus hernia, to evaluate the role of upper gastrointestinal endoscopy in the preoperative diagnosis and planning & to determine the utility of intraoperative endoscopy in guiding the surgical repair and ensuring its technical adequacy.

main questions are:

  • which one of these techniques is safer with higher clinical efficacy represented by relief of GERD symptoms ?
  • does upper GI endoscopy have a role in preoperative stage regarding diagnosis of condition and planning of treatment ?
  • does upper GI endoscopy have a role in intraoperative stage regarding guiding the surgical repair and ensuring its adequacy ?

all participants will be randomly assigned in one of two groups:

  • one group undergoing Laparoscopic Nissen Fundoplication
  • the other group undergoing Laparoscopic Hill-Snow repair

each participsant will have preopertive, intraoperative and postoperative upper GI endoscopy to assess objectively clinical efficacy of both techniques and to define the integral role of endoscopy in all three perioperative stages

详细描述

Congenital hiatus hernia (CHH), though less common than acquired forms, presents a significant clinical challenge, particularly in the pediatric and young adult populations. It is characterized by a congenital defect in the phrenoesophageal membrane, allowing for herniation of gastric cardia into the mediastinum. This anatomical disruption compromises the lower esophageal sphincter (LES) mechanism, leading to severe gastroesophageal reflux disease (GERD), which can result in failure to thrive, esophagitis, recurrent aspiration pneumonia, and long-term sequelae like Barrett's esophagus.

When medical management fails or in cases of significant complications, surgical intervention is imperative. The goals of surgery are the anatomical reduction of the hernia, reconstruction of the esophagogastric junction (EGJ), and restoration of an effective anti-reflux barrier. Laparoscopic repair has become the gold standard due to its benefits of reduced postoperative pain, shorter hospital stay, and better cosmesis.

Two prominent laparoscopic techniques are:

Laparoscopic Nissen Fundoplication (LNF): A 360-degree wrap is the most common anti-reflux procedure worldwide. It is highly effective in controlling reflux but is associated with potential side effects like gas-bloat syndrome, dysphagia, and inability to belch.

Laparoscopic Hill-Snow Repair (LHS): This technique focuses on a precise anatomical restoration of the EGJ by anchoring it to the median arcuate ligament of the diaphragm. It aims to recreate the valvular mechanism without a complete wrap, potentially reducing the typical side effects of Nissen fundoplication.

Endoscopy plays a crucial but often under-standardized role in the perioperative management of CHH.

Preoperatively, it is essential for diagnosing esophagitis, Barrett's metaplasia, and ruling out other pathologies. It also helps in assessing the size and reducibility of the hernia.

Intraoperatively, endoscopy (laparoscopic-endoscopic collaboration) can guide the surgeon in assessing the tightness of the fundoplication, identifying the Z-line for accurate placement of the wrap, and ensuring no mucosal perforation has occurred.

Postoperatively, endoscopy is the primary tool for evaluating anatomical success, detecting recurrence, and managing persistent symptoms like dysphagia.

While numerous studies have compared various fundoplication techniques for GERD, there is a paucity of literature directly comparing LNF and LHS specifically in the context of congenital hiatus hernia. Furthermore, a systematic protocol defining the integral role of endoscopy in all three perioperative stages is lacking. This study aims to fill this gap by providing a comparative analysis of the functional outcomes and complications of these two techniques and by establishing a standardized perioperative endoscopic protocol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged less than 18 years including both sexes with a confirmed diagnosis of congenital hiatus hernia
  • Diagnosis of hiatus hernia refractory to maximal medical therapy (PPI for ≥12 weeks) AND/OR presence of complications (e.g., erosive esophagitis, Barrett's esophagus, recurrent aspiration pneumonia, failure to thrive)
  • Objective evidence of pathological GERD on upper endoscopy e.g: erosive esophagitis, Barrett's esophagus.

排除标准

  • Previous esophageal or gastric surgery
  • Contraindications to laparoscopy e.g: cardiopulmonary decompensated cases.

研究组 & 干预措施

Laparoscopic Hill-Snow repair

Experimental

干预措施: Laparoscopic Hill-Snow repair (Procedure)

Laparoscopic Nissen Fundoplication

Active Comparator

干预措施: Laparoscopic Nissen Fundoplication (Procedure)

结局指标

主要结局

Degree of relief of GERD symptoms assessed by GERD Health-Related Quality Of Life (GERD-HRQL) score

时间窗: 6 months postoperatively

The GERD-HRQL questionnaire was developed and validated to measure changes of typical GERD symptoms such as heartburn and regurgitation in response to surgical or medical treatment. Total Score: Calculated by summing the individual scores to 15 questions \* Greatest possible score (worst symptoms) = 75 \* Lowest possible score (no symptoms) = 0 Heartburn Score: Calculated by summing the individual scores to 6 questions \* Worst heartburn symptoms = 30 \* No heartburn symptoms = 0 \* Scores less than or equal to 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to 6 questions . \*Worst regurgitation symptoms = 30 \* No regurgitation = 0 \* Scores less than or equal to 12 with each individual question not exceeding 2 indicate regurgitation.

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Hassaan Hamdy

Assistrent Lecturer

Minia University

研究点 (1)

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