Active not recruitingOBSERVATIONAL

Minimally Invasive Surgery of the Gastro-esophageal Junction

This study is about a type of surgery called Minimally Invasive Surgery of the Gastro-esophageal Junction (MISGEJ). This is a keyhole operation for conditions affecting where your food pipe meets your stomach, such as achalasia (food pipe doesn't relax properly), paraesophageal hernia (part of the stomach pushes up), GERD (heartburn), and certain pouches (diverticula). Researchers want to understand how people get on in the short and long term after this surgery. They will ask participants to fill out questionnaires each year to see how their quality of life and daily activities are, and they'll also look at hospital notes to track their health progress.

At a glance

Status

Active not recruiting

Sponsor

Ottawa Hospital Research Institute

Enrolment target

200

Start

01 Nov 2007

Estimated completion

01 Nov 2027

Achalasia Paraesophageal Hernia GERD Epiphrenic Diverticula Zenker's Diverticulum

What is this study about?

This study is focusing on a type of surgery performed using a 'keyhole' approach, which means it uses small cuts rather than a large open cut. The surgery is for problems that happen where your food pipe (oesophagus) joins your stomach. These problems can include conditions like achalasia, where the muscles in your food pipe don't relax properly to let food down, or a paraesophageal hernia, where part of your stomach pushes up into your chest. It also covers conditions like GERD (gastro-oesophageal reflux disease), which causes heartburn, and certain small pouches called diverticula that can form in the food pipe.

The main goal of this study is to see how people recover and get on in the long run after having this keyhole surgery. The doctors want to find out how well the surgery works for different people and how it affects their daily lives. By understanding this, they hope to improve care for future patients.

To do this, they will keep track of people who have had this specific type of surgery. They will ask participants to answer questions about their health and how they are feeling, and they will also look at their hospital records. This will help them gather important information about the benefits and any challenges people might face after the operation.

Key takeaways

It studies keyhole surgery for issues where the food pipe meets the stomach.
Participation involves filling out yearly health questionnaires.
Researchers will also check existing hospital records.
It helps doctors understand long-term surgery outcomes.
You must be 18 or older and having the relevant surgery at The Ottawa Hospital.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. The study is specifically looking at people who are having a particular type of keyhole surgery at The Ottawa Hospital. This surgery is for conditions affecting where your food pipe meets your stomach.

There aren't many strict rules about who can't join. The main thing is that you must be at least 18 years old. If you are younger than 18, unfortunately, you won't be able to take part in this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having a keyhole surgery for your food pipe/stomach junction?
Is your surgery taking place at The Ottawa Hospital?
Are you able to fill out yearly questionnaires about your health?

Answer every question to see your result.

What does participation involve?

If you join this study, your participation will mainly involve answering some questions about your health and how you feel. You will be asked to fill out questionnaires once a year. These questionnaires will ask about your quality of life and how well you can do your daily activities after your surgery. The researchers will also regularly look at your hospital notes (like your medical history and test results) to track your health over time. There are no additional appointments, medications, or changes to your usual care involved in this study. The total duration of your participation will depend on how long the study continues to follow people up after their surgery.

Potential risks and benefits

Taking part in this study won't change your medical treatment or care. There are no direct medical benefits or risks from simply answering questions or having your existing medical records reviewed. However, by participating, you will be helping doctors learn more about the long-term effects of this surgery, which could benefit future patients. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Ottawa Hospital Research Institute
Verified postcode
Ottawa, Canada

Common questions

What kind of surgery is this study about?

It's about a keyhole (minimally invasive) surgery for problems where your food pipe joins your stomach, like heartburn or difficulty swallowing.

Will I have to take any new medicines?

No, this study doesn't involve giving you any new medicines. Your treatment won't change.

How often will I be contacted?

You'll be asked to fill out some questionnaires once a year.

Can anyone take part in this study?

You need to be 18 years or older and having this specific keyhole surgery at The Ottawa Hospital.

What happens if I change my mind about participating?

You can leave the study at any time, and it won't affect your medical care.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.