Active not recruitingOBSERVATIONAL

Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery

This research is looking at two different types of stitches used during robotic-assisted gastric bypass surgery, a common operation for people with severe obesity. Specifically, they want to compare a newer type of stitch called Symmcora® with a standard stitch called Novosyn®. Both stitches are used to connect parts of your stomach and intestine after surgery. By comparing them, the researchers hope to understand if the newer stitch is as safe and effective as the traditional one. Participants will be randomly assigned to receive one of these stitches during their surgery. The study aims to improve how this important surgery is done and ensure the best possible outcomes for patients in the future.

At a glance

Status

Active not recruiting

Sponsor

Aesculap AG

Enrolment target

150

Start

12 Oct 2022

Estimated completion

01 Jan 2027

Adiposity

What is this study about?

This study is designed to help doctors understand the best way to perform part of a weight-loss operation called robotic-assisted gastric bypass surgery. During this surgery, doctors need to join sections of your stomach and intestine together using stitches.

Imagine you have two different kinds of thread, both designed for stitching, and you want to know which one works best for a specific job. In this study, doctors are comparing two types of stitches: one called Symmcora® and another called Novosyn®. They are both used in routine operations, but researchers want to see if one might offer advantages over the other for connecting the stomach and small intestine.

The main goal is to make sure that the surgery is as safe and effective as possible for everyone. By carefully comparing these two stitches, doctors can learn more about which one might lead to better healing and fewer problems after surgery. This could ultimately improve care for many patients needing gastric bypass surgery in the future.

Key takeaways

This study compares two types of stitches (Symmcora® vs. Novosyn®) for gastric bypass surgery.
It aims to find out if a newer stitch performs as well as a standard one.
Participation involves receiving one of these stitches during your planned surgery.
Both stitches are regularly used in surgery; there are no extra risks from the study itself.
The study helps improve future care for patients having weight-loss surgery.

Who may be eligible?

If you're considering taking part in this study, you might be eligible if you're an adult aged 18 or over and are already scheduled for robotic-assisted gastric bypass surgery. This surgery usually happens when someone has a high Body Mass Index (BMI) of 40 or more, or a BMI of 35 or more along with other health issues like high blood pressure, type 2 diabetes, or diagnosed sleep apnoea.

You also need to be able to understand and sign a consent form, showing you agree to take part.

However, you wouldn't be able to join the study if you're having emergency surgery, have had stomach surgery before, are pregnant or breastfeeding, or have certain allergies to the materials used in the stitches. Also, if you're already in another research study or can't commit to following the study's plan, you wouldn't be able to participate.

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 scheduled for robotic-assisted gastric bypass surgery?
Is your BMI 40 or above, or 35 or above with related health problems like diabetes or high blood pressure?
Have you *not* had stomach surgery before?
Are you able to understand and sign a consent form for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll still be having your planned robotic-assisted gastric bypass surgery. The main difference is that during your operation, you will be randomly assigned to have one of two types of stitches used to connect parts of your digestive system – either Symmcora® or Novosyn®. You won't know which type of stitch is used, and neither will your care team, to keep the study fair.

Both stitches are used in standard practice, and your surgeon will use them in the usual way. There aren't any extra visits or assessments specifically because of the study beyond what would normally be part of your surgery and recovery care. The study largely focuses on which stitch is used during the operation itself. Your follow-up after surgery will be the same as any other patient having this procedure. The total duration of your involvement in the study really covers the time of your surgery and subsequent recovery.

Potential risks and benefits

Participating in this study might offer the benefit of contributing to medical knowledge that could improve future surgical practices for gastric bypass patients. You would be receiving a stitch that is either a standard treatment or a newer one that surgeons believe is suitable for use. However, as with any surgery, there are always potential risks, and these are not changed by being part of the study; they are the same risks associated with gastric bypass surgery itself. There are no additional risks directly linked to being in this study, as both types of stitches are routinely used. You always have the right to withdraw from the study at any point without affecting your medical care.

Locations (1)

Universitätsklinikum Schleswig-Holstein
Verified postcode
Kiel, Germany

Common questions

What is robotic-assisted gastric bypass surgery?

It's a type of weight-loss surgery where a surgeon uses robotic tools to make your stomach smaller and reroute your small intestine, helping you feel full sooner and absorb fewer calories.

What are stitches used for in this surgery?

Stitches, or sutures, are vital for joining different parts of your stomach and intestine together after they've been reshaped. This creates the new digestive pathway.

Will I know which stitch I receive?

No, you won't know whether you received the Symmcora® or Novosyn® stitch. This is to ensure the study is fair and unbiased, allowing researchers to see the true effects without influence.

Do I have to do anything extra if I join the study?

No, there are no extra appointments, tests, or treatments specifically for this study. You'll simply undergo your planned surgery as normal, with one of the two stitches being used.

Can I change my mind about participating?

Yes, you can decide to withdraw from the study at any time without having to give a reason. Your medical care will not be affected.