German-funded Laparoscopic Approach to Cervical Cancer
This study, called G-LACC, is looking at the best way to treat early-stage cervical cancer. Doctors are comparing two main types of surgery: keyhole surgery (which can include robot-assisted surgery) and traditional open surgery. Both types involve removing the womb and sometimes other nearby tissues. The main goal is to find out if keyhole surgery is as effective as open surgery in stopping the cancer from returning. They are also looking at how each surgery affects a patient's life quality, recovery, and any side effects. Patients will be randomly put into one of the two groups, and their health will be followed for at least five years after their operation.
At a glance
What is this study about?
When someone is diagnosed with early-stage cervical cancer, an operation to remove the womb (a hysterectomy) is a common treatment. This G-LACC study has been set up to carefully compare two different ways of performing this surgery: the traditional 'open' method, which involves a larger cut in the tummy, and a 'minimally invasive' or 'keyhole' method, which uses smaller cuts and special instruments, sometimes with robotic help.
The main reason for this study is to see if the keyhole approach is just as good as the open surgery when it comes to making sure the cancer doesn't come back. This is very important because keyhole surgery can sometimes mean a faster recovery time and less pain for patients. The study will be looking closely at how well patients do after either type of surgery, including checking for any cancer recurrence, overall health, and quality of life.
Doctors participating in this study want to make sure they are offering the best and safest treatment options. By comparing these two surgical methods in a structured way, they hope to get clear answers that will help guide future treatment decisions for women with early cervical cancer. This way, patients can be confident they are receiving the most effective care.
Key takeaways
- Compares keyhole vs. open surgery for early cervical cancer.
- Aims to see if keyhole surgery is as effective as open surgery in preventing cancer return.
- Patients are randomly assigned to one surgical group.
- Looks at cancer recurrence, survival, quality of life, and recovery.
- Involves a minimum of 5 years of follow-up after surgery.
- Results will help shape future cervical cancer treatments.
Who may be eligible?
This study is looking for women aged 18 or over who have been diagnosed with early-stage cervical cancer. This includes specific types of cancer cells like adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma. Your cancer needs to be within a certain size range (less than 4 cm) and at an early stage (FIGO stage IA2, IB1, or IB2). You also need to be well enough for surgery and to commit to the follow-up appointments.
There are also situations where you wouldn't be able to join the study. For example, if your cancer is a different type, or if it's larger than 4 cm or has spread beyond the early stages. You also can't have had radiation treatment to your tummy or pelvis before, or have certain other serious health problems that would make surgery unsafe or make it difficult for you to complete the study.
Very importantly, if you are pregnant, you cannot take part. Additionally, if you've had certain other cancers recently (within the last 5 years) or if doctors don't think you can cope with the surgery positions or follow-up plan, you wouldn't 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 a woman aged 18 or older?
- Do you have an early-stage cervical cancer diagnosis (like squamous, adeno-, or adenosquamous carcinoma)?
- Is your tumour less than 4 cm in size, and is your cancer at an early stage (IA2, IB1, or IB2)?
- Are you well enough for surgery and able to attend follow-up appointments for at least 5 years?
- Have you NOT had radiation treatment to your tummy or pelvis before?
- Are you NOT pregnant?
What does participation involve?
If you decide to take part in this study, you would first have a thorough check-up to make sure you meet all the requirements. Once confirmed, you would be randomly assigned to receive either the open hysterectomy or the keyhole (minimally invasive) hysterectomy. This is like flipping a coin, so neither you nor your doctor chooses which surgery you get.
The surgery itself would be carried out by experienced surgeons. After your operation, you would have regular follow-up appointments and checks for at least five years. These appointments are important to monitor your recovery, check for any complications, see how you're feeling, and ensure the cancer has not returned. In total, your involvement in the study, including all follow-ups, would last at least five years from your surgery date.
Potential risks and benefits
Locations (14)
- Ludwigsburg Hospital, Department of Gynecology and ObstetricsVerified postcodeLudwigsburg, Germany· Recruiting
- University Medical Center Tübingen, Department of GynecologyVerified postcodeTübingen, Germany· Recruiting
- Hochtaunus-Clinics Bad Homburg, Department of GynecologyVerified postcodeBad Homburg, Germany· Recruiting
- University Medical Center Göttingen, Department of Gynecology and ObstetricsVerified postcodeGöttingen, Germany· Recruiting
- Hannover Medical School, Department of Gynecology and ObstetricsVerified postcodeHanover, Germany· Recruiting
- Hospital Lüneburg, Department of GynecologyVerified postcodeLüneburg, Germany· Recruiting
- Hospital Bielefeld - Center, Department of GynecologyVerified postcodeBielefeld, Germany· Recruiting
- University Medical Center Düsseldorf, Department of Gynecology and ObstetricsVerified postcodeDüsseldorf, Germany· Recruiting
- Protestant Hospital Wesel, Gynecological Cancer CenterVerified postcodeWesel, Germany· Recruiting
- University Medical Center Mainz, Department of Obstetrics and GynecologyVerified postcodeMainz, Germany· Recruiting
- University Hospital Schleswig-Holstein, Campus Kiel, Department of Gynecology and ObstetricsVerified postcodeKiel, Germany· Recruiting
- Vivantes Auguste-Viktoria-Hospital, Department of GynecologyCity onlyBerlin Schöneberg, Germany· Recruiting
Common questions
What is 'early-stage cervical cancer'?
This means the cancer has been found early and has not spread far from the cervix.
What's the difference between keyhole and open surgery?
Keyhole surgery uses several small cuts and special tools, sometimes with a robot. Open surgery uses a single, larger cut in your tummy.
Will I get to choose which surgery I have?
No, you will be randomly put into one of the two groups, like drawing lots, to ensure the study is fair.
How long will I be followed after surgery?
Your health will be monitored for at least five years after your operation to check your recovery and ensure the cancer hasn't returned.
What if I change my mind about participating?
You can leave the study at any time, and this will not affect your future medical care.
How to find out more
Peter Hillemanns, Prof. Dr.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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