Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.
2026年7月17日 更新者：Katya Todorova、Sofia Med Hospital
Laparoscopic Nissen Versus Toupet Fundoplication for Gastroesophageal Reflux Management in Patients With Hiatal Hernia: A Patient- and Assessor-Blinded Randomized Controlled Trial
This randomized controlled trial compares laparoscopic Nissen fundoplication and laparoscopic Toupet fundoplication in patients undergoing surgical treatment for hiatal hernia associated with gastroesophageal reflux disease.
Participants will be randomly assigned to one of two surgical groups.
The study will evaluate postoperative pain, health-related quality of life, hospital stay, recurrence of reflux symptoms, gas-bloat symptoms, operative time, fundoplication time, and postoperative complications.
研究概览
地位
招聘中
研究类型
介入性
注册 (估计的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Katya T. Todorova, PhD
- 电话号码：+359884744833
- 邮箱：katya.todorowa@gmail.com
研究联系人备份
- 姓名：Teodor D. Atanasov, Assoc. Prof.
- 电话号码：+359899802612
- 邮箱：teodor.atanassov@gmail.com
学习地点
-
-
Sofia-Grad
-
Sofia、Sofia-Grad、保加利亚、1517
- 招聘中
- UMHAT Sofiamed
-
接触：
- Katya T. Todorova, PhD
- 电话号码：0884744833
- 邮箱：katya.todorowa@gmail.com
-
接触：
-
首席研究员：
- Teodor D Atanasov, Assoc. prof.
-
首席研究员：
- Katya T Todorova
-
副研究员：
- Alexander I Tsvetanov
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients aged 18 to 90 years
- Patients diagnosed with primary hiatal hernia by fibrogastroscopy and/or barium swallow examination
- Patients with symptoms of gastroesophageal reflux disease
- Patients scheduled for elective laparoscopic hiatal hernia repair with fundoplication
- Patients able to provide informed consent
Exclusion Criteria:
Patients younger than 18 years or older than 90 years Patients with recurrent hiatal hernia Patients who are not suitable for general anesthesia Patients who prefer a surgical approach other than laparoscopic surgery Patients who are unable or unwilling to provide informed consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Nissen fundoplication
Participants assigned to this arm will undergo laparoscopic hiatal hernia repair with Nissen fundoplication.
The procedure includes a complete 360° fundoplication performed as part of standard laparoscopic antireflux surgery.
|
The procedure includes a complete 360° fundoplication performed as part of standard laparoscopic antireflux surgery.
|
|
有源比较器：Toupet Fundoplication
Participants assigned to this arm will undergo laparoscopic hiatal hernia repair with Toupet fundoplication.
The procedure includes a partial posterior 270° fundoplication performed as part of standard laparoscopic antireflux surgery.
|
The procedure includes a partial posterior 270° fundoplication performed as part of standard laparoscopic antireflux surgery.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative pain score at 24 hours
大体时间：24 hours after surgery
|
Postoperative pain will be assessed 24 hours after surgery using the Visual Analog Scale.
The score will be used to compare early postoperative pain between participants undergoing laparoscopic Nissen fundoplication and those undergoing laparoscopic Toupet fundoplication.
|
24 hours after surgery
|
|
Postoperative Pain Score at 7 Days
大体时间：7 days after surgery
|
Postoperative pain will be assessed 7 days after surgery using the Visual Analog Scale.
The score will be used to evaluate and compare short-term postoperative pain between the two intervention groups.
|
7 days after surgery
|
|
Change in Health-Related Quality of Life After Surgery
大体时间：Preoperatively, 1 week, 4 weeks
|
Health-related quality of life will be assessed using the GERD-Health Related Quality of Life questionnaire.
Preoperative scores will be compared with postoperative scores in order to evaluate changes in reflux-related symptoms and quality of life after laparoscopic Nissen or Toupet fundoplication.
|
Preoperatively, 1 week, 4 weeks
|
|
Postoperative Hospital Stay
大体时间：From the day of surgery until hospital discharge - up to 30days
|
Postoperative hospital stay will be measured as the number of days from the day of surgery until hospital discharge.
The duration of hospital stay will be compared between the Nissen and Toupet fundoplication groups.
|
From the day of surgery until hospital discharge - up to 30days
|
|
Recurrence of Gastroesophageal Reflux Symptoms
大体时间：4 weeks and 1 year after surgery
|
Recurrence of gastroesophageal reflux symptoms will be assessed during postoperative follow-up.
The presence or absence of recurrent reflux symptoms will be recorded and compared between the two intervention groups.
|
4 weeks and 1 year after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Operative Timе
大体时间：Intraoperative
|
Operative time will be measured in minutes from the beginning to the end of the laparoscopic surgical procedure.
Total operative time will be compared between participants undergoing Nissen fundoplication and those undergoing Toupet fundoplication.
|
Intraoperative
|
|
Fundoplication Time
大体时间：Intraoperative
|
Fundoplication time will be measured in minutes as the time required to perform the fundoplication component of the procedure.
This measure will be used to compare the technical duration of Nissen and Toupet fundoplication.
|
Intraoperative
|
|
Gas-Bloat Symptoms
大体时间：3 days; 1 week
|
Postoperative gas-bloat symptoms will be assessed during follow-up.
The presence or absence of symptoms such as bloating, inability to belch, or increased abdominal gas-related discomfort will be recorded and compared between the two groups.
|
3 days; 1 week
|
|
Postoperative Complications
大体时间：Up to 30 days after surgery
|
Postoperative complications will be recorded according to type and frequency.
The number and nature of postoperative complications will be compared between the Nissen and Toupet fundoplication groups.
|
Up to 30 days after surgery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年5月29日
初级完成 (估计的)
2026年7月30日
研究完成 (估计的)
2027年1月31日
研究注册日期
首次提交
2026年6月19日
首先提交符合 QC 标准的
2026年7月17日
首次发布 (实际的)
2026年7月22日
研究记录更新
最后更新发布 (实际的)
2026年7月22日
上次提交的符合 QC 标准的更新
2026年7月17日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.