临床试验/NCT05662735

NCT05662735尚未招募4 期

Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair With Sutures Alone Versus Sutures Reinforced With Mesh for Hiatus Hernia: A Long Term Follow-Up

Rijnstate Hospital0 个研究点目标入组 60 人开始时间: 2023年3月1日最近更新: 2022年12月22日

适应症

试验速览

阶段: 4 期
状态: 尚未招募
发起方
入组人数: 60
主要终点: Percentage of objective recurrence of a hiatal hernia

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.

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)

盲法说明

Patients were blinded for repair with sutures alone or sutures with mesh augmentation

入排标准

年龄范围: 16 Years 至 100 Years（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Participant of the initial PRIME study

排除标准

•No informed consent
•Additional hiatal hernia repair surgery during the follow-up period
•Pregnancy
•Patients that have stated they do not want to be approached for follow-up research

结局指标

主要结局

Percentage of objective recurrence of a hiatal hernia

时间窗: 5-10 years

Objective measurement of the integrity of the hiatal hernia repair by CT-imaging

次要结局

Percentage of clinical recurrence of a hiatal hernia(5-10 years)
Symptoms of gastroesophageal reflux disease(5-10 years)
Patient satisfaction(5-10 years)

研究者

发起方

Rijnstate Hospital

申办方类型

Other

责任方

Sponsor

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