Not yet recruitingOBSERVATIONAL

Robotic vs. TaTME Rectal Surgery (ROTA STUDY)

This study, called ROTA, is looking at two newer surgical techniques for bowel cancer that is low down in the rectum: robotic surgery (RLAR) and transanal total mesorectal excision (TaTME). Both methods aim to remove the cancer completely while overcoming challenges like obesity or a narrow pelvis. The study wants to compare how effective each method is, focusing on whether the cancer comes back, how long patients stay in hospital, and complication rates. Importantly, only very experienced surgeons will be performing these operations within the study to ensure the results are reliable. It will also look at patient quality of life after surgery. This is a pilot study to help plan a larger trial in the future.

At a glance

Status

Not yet recruiting

Sponsor

Odense University Hospital

Enrolment target

330

Start

15 Nov 2021

Estimated completion

01 Nov 2026

Rectal Cancer

What is this study about?

This research study, known as the ROTA study, is investigating two modern surgical techniques used for treating rectal cancer, specifically when the cancer is located lower down in the bowel. These new techniques are robotic-assisted surgery (called RLAR) and a method performed through the anus (called TaTME). Both aim to remove the entire cancerous area and surrounding tissue effectively. They were developed to help surgeons operate more easily in challenging situations, such as when a patient is obese or has a narrow pelvis, or when the tumour is quite large or very low down. This can make traditional surgery more difficult.

While both robotic surgery and the transanal approach have benefits and drawbacks, we don't yet have enough information comparing them directly, especially when performed by highly skilled surgeons. Previous studies often included surgeons who were still learning the techniques, which can sometimes affect the results. This study aims to provide a clearer picture by focusing only on experienced surgeons in multiple hospitals.

The main goal of this study is to see which of these two procedures leads to better long-term outcomes, particularly whether the cancer is less likely to come back. Researchers will also be looking at other important aspects like how quickly patients recover, their hospital stay, any complications that arise, and ultimately, how their quality of life is affected after surgery. This initial study will help us understand if a larger trial comparing these two methods is needed in the future.

Key takeaways

Compares two advanced surgeries for low rectal cancer: robotic vs. transanal keyhole.
Aims to find which surgery offers better long-term cancer control and recovery.
Only very experienced surgeons will perform operations in the study.
Will assess important factors like complications and quality of life.
This is a pilot study to guide future larger research.

Who may be eligible?

To be considered for this study, you would need to be an adult (18 years or older) who has been diagnosed with rectal cancer. Your medical team would have discussed your treatment plan, which would include surgery to remove the affected area.

Your cancer should be located 12 cm or less from the anal opening. You must also be able to understand the study and agree to take part, and your doctors must believe that you are well enough to participate. You should not have any other medical conditions that would make taking part unsafe.

However, if you are pregnant, breastfeeding, or planning to become pregnant, you would not be able to join. Additionally, if your medical team anticipates that your life expectancy is less than six months, or if you have other serious health issues that could interfere with the study's results or your safety, you would not be eligible.

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?
Have you been diagnosed with rectal cancer planned for surgery?
Is your tumour located 12 cm or less from the anal opening?
Are you not pregnant or breastfeeding?
Do you have a general life expectancy of more than 6 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will undergo standard surgery for your rectal cancer, which will be either robotic-assisted surgery or the transanal approach, performed by a very experienced surgeon. The choice of surgery will be based on what your medical team decides is best for you.

During your time in the study, doctors will closely monitor your recovery, complications, and how your cancer responds to treatment. You will be asked to complete questionnaires to assess your quality of life before your surgery, and then again at 6 months and 12 months after your ileostomy (a temporary surgical opening) has been reversed. The total duration of follow-up for the study will extend over three years to monitor for any recurrence of the cancer. There are no additional medications involved other than those you would normally receive as part of your treatment.

Potential risks and benefits

Participating in this study might offer the benefit of receiving one of the most advanced surgical techniques from a highly experienced surgeon for your rectal cancer. There is also the potential to contribute valuable information that could improve care for future patients. As with any surgery, there are potential risks, including complications like infection, bleeding, or issues with wound healing. The study aims to meticulously track all complications. You are free to withdraw from the study at any time without affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Issam al-Najami
Verified postcode
Svendborg, Denmark
Jim Khan
Verified postcode
Portsmouth, United Kingdom

Common questions

What is 'total mesorectal excision'?

It's a type of surgery where the surgeon removes the tumour along with a specific area of surrounding fatty tissue (the mesorectum) to ensure all cancer cells are taken out.

What's the difference between robotic and transanal keyhole surgery?

Robotic surgery uses small cuts and instruments controlled by a surgeon from a console. Transanal surgery involves operating through the anus to access the tumour, also using small instruments.

Why is it important that only experienced surgeons are doing the operations?

By using only highly experienced surgeons, the study can get a clearer picture of how effective each surgery truly is, without the results being affected by someone still learning the technique.

Will I have a choice of which surgery I receive?

The type of surgery will be decided by your medical team based on what they believe is best for your specific case and tumour.

What does 'quality of life questionnaires' involve?

These are forms you fill out about how you're feeling, your daily activities, and your overall well-being, to understand the impact of the surgery on your life.

How to find out more

Issam Al-Najami, phd

al_najami@yahoo.com 51909297 Official trial record

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