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Participant Selection and Purpose of Study
LACE is a study comparing two different surgical techniques for the treatment of endometrial (uterine) cancer. To be selected as a possible participant in this study you must be diagnosed with endometrial cancer on either a recent D&C or a sampling of endometrial cells from the uterus. Your work-up must reveal no spread of tumour and an “early” cancer should be anticipated. The standard treatment of this condition is surgery.

Two surgical techniques are available:
Method 1: Most centres worldwide would open the abdomen through a vertical incision or a lower transverse incision and remove the uterus, the fallopian tubes and the ovaries. While you are still under anaesthetic (asleep) an assessment of the uterus is performed during the operation by a pathologist and the results of this assessment are reported to the surgeon in the operating theatre. Your surgeon will make a decision whether to remove some lymph nodes in the pelvis.

Method 2: The other method is a new method and it is called laparoscopy (“keyhole surgery”) where no big incision needs to be done through the abdomen. The surgery is carried out through little incisions in the abdomen, none of which is larger than 1 cm. A camera is inserted into the abdomen and the surgeon controls the operation on a screen to which the images of inside the abdomen are transferred. The extent of the operation is exactly the same as with the method above. Your surgeon will remove the uterus, the fallopian tubes and the ovaries. While you are still under anaesthetic (asleep) an assessment of the uterus is performed during the operation by a pathologist and the results of this assessment are reported to the surgeon in the operating theatre. Your surgeon will make a decision whether to remove some lymph nodes in the pelvis.

We have performed laparoscopic surgery very often and we are encouraged by the preliminary results. Our preliminary data have shown that laparoscopic treatment of early endometrial cancer can be done, it is safe and it may have potential advantages for patients. Additional data have shown that no difference exists in the prognosis of patients with endometrial cancer when they had laparoscopic or open surgery. However, no formal comparison has been made between laparoscopic and open surgery in this patients’ group.

Therefore we want to compare both techniques to demonstrate that both techniques are equally effective in terms of prognosis but superior with respect to quality of life and treatment-related morbidity of surgery. Without such a formal comparison (clinical trial), final treatment recommendations cannot be made.

Description of Study
Should you agree to this important study, you will be asked to sign an informed consent. You will be randomly allocated to one of the two groups (laparoscopy or open surgery) with an equal chance being allocated to either group. Your surgeon and you will not know until the day before surgery which type of surgery you will have. This “randomisation” guarantees that a fair and balanced comparison can be made between the two different surgical groups. If randomisation would not be possible, the outcomes of the study would be flawed and irrelevant for patients with endometrial cancer in Australia.

The preoperative work-up for both groups includes medical work-up, blood tests, X-rays, CT Scan or an MRI Scan and an ECG. The preoperative work-up is exactly the same for both groups and reflects our routine protocol. In addition to the routine protocol we ask you for your preference of the type of surgery and to complete a questionnaire taking approximately 10 minutes of your time about your quality of life before surgery and again 1 week, 1 month, 3 months, 6 months, 1.5 years, 2.5 years, 3.5 years and 4.5 years after surgery. You will also be asked to complete a questionnaire containing demographic information.

No difference would be made with respect to the recommendation of postoperative treatment (radiotherapy, chemotherapy) and your follow-up between the two treatment modalities.

Alternative Treatments
Should you decide not to take part in this clinical trial, the current "gold" standard treatment for endometrial cancer (Laparotomy, referred to as Method 1 above) will be offered to you.

Potential Risks
Every intervention (surgery) carries risks. Apart from medical and anaesthetic risks we also know of surgical risks. These risks occur irrespective of surgery type (laparotomy or laparoscopic surgery). Uncommon events include injury to the bowel, the bladder, the ureter, nerves or large blood vessels.

Potential Benefits
The potential benefits are a shorter hospital stay for patients who will have a laparoscopic procedure. However, the main benefactors of this study will not be the women on this study but be the women in Australia requiring a hysterectomy in the future. This study will be able to clarify which surgical technique is associated with the least treatment-related morbidity.

Confidentiality and Disclosure of Information
All aspects of the study, including results, will be strictly confidential and only your doctors and the staff involved in the study will have access to information on participants. A report of the study may be submitted for publication, but individual participants will not be identifiable in such a report.

Costs
Your participation in this study will not influence the amount of money (if any) you have to pay for your treatment at this institution. You will not be paid for taking part in the study. If any complications of the disease or treatment occur, the hospital will provide appropriate treatment for these problems.

What are my rights as a participant?
Even after you agree to take part in this study, you may withdraw at any time. Before you withdraw, you should first talk to one of the researchers or nurses involved. This will allow them to inform you of any medical problems that could result when treatment stops. You can choose to withdraw one of two ways. You can stop your study treatment, but still allow the study doctor to follow your care. Alternatively, you can stop your study treatment and not have any further contact with the study staff. Either way, your decision will not affect your medical treatment, or your relationship with those treating you. You will still be offered all available care that suits your needs and medical condition.