Have the LACC trial results changed your clinical practice?

I get this question asked a lot. And, yes, the results of the LACC trialhave changed my practice since I became aware of them.

First, my practice to treat patients with uterinecancer has not changed; I treat them virtually all laparoscopically based on high-level, randomized evidence. Patients who need a hysterectomy for fibroids, adenomyosis and other benign pathology will still have a TLH. 

Secondly, my patients with operable cervicalcancer will now be offered an open, abdominal approach. I open the abdomen through a Maylard incision. My operating time is similar, the blood loss may be slightly higher. The length of hospital stay is longer with most patients staying for 3 to 5 nights. My overall complication rate has not increased but I operated on one patient 4 months ago who still suffers from a loss of bladder sensation. I find it more important than ever to record all my surgical outcomes in SurgicalPerformance.com.

The LACC trial results also had another profound impact on my practice. I find it increasingly difficult to trust retrospective data. Let me go back a step.  

Dr Ramirez and I started the LACC trial because we believed in minimally invasive surgery. We believed that anything that can be done through open surgery, can be achieved though minimally invasive surgical approaches. To establish laparoscopic radical hysterectomy as the new gold standard, we felt an RCT would be best to prove its effectiveness and equivalence compared to open surgery. We both regard ourselves as proponents of minimally invasive surgery. I was the PI on the LACE trial that helped establish Total Laparoscopic Hysterectomy (TLH) as the approach to choose for early stage endometrial cancer. 

When we initiated the LACC trial in 2008, we were surprised to learn that many colleagues declined to enroll patients into the LACC trial. These surgeons felt they could not go back in time and randomize patients to open surgery. They felt it was unethical to do so because minimally invasive radical hysterectomy was now “standard”, despite absence of an RCT. They considered a surgical approach “standard” when this procedure had been evaluated in not even one prospective study yet. Are surgeons too quick to declare a new surgical procedure the “standard” without evidence? Do surgeons declare a procedure “standard” because we simply derive great satisfaction from doing them? 

I am wondering how many other procedures we do and declare “State of the Art” without evaluating their outcomes? 

I am personally disappointed about the LACC trial results. I would have wished the results would have shown short-term benefits for minimally invasive radical hysterectomy and at least equivalent survival outcomes.  

Even worse: There were no signs that any one or two of the centres that contributed to enrolment could have skewed the results; the poor results for minimally invasive surgery were distributed evenly across all sites. There was also no sign that the inferior survival outcome was limited to smaller tumours; it was evenly distributed across all tumour sizes and characteristics. 

As disappointed I am with the outcomes, I am proud to be part of a team that initiated and lead the LACC trial and helped to make information available so that my colleagues and I can consider that information for clinical decision making. From the responses that I receive at conferences and through social media I believe that the trial results did change the clinical practice of gynaecological cancer surgeons worldwide and may save several hundreds of lives every year. 

Sometimes I get asked if one RCT is enough to change clinical practice. The LACC trial is the only RCT we have available and apart from the population-based studythat was published in the same issue of NEJM constitutes the only high-level evidence that could inform clinical practice. However, many colleagues and friends collect the outcomesof their radical hysterectomies prospectively and can refer to those outcomes in their decision-making discussions with patients, which again should be relevant to patients. 

Our team of investigators are preparing more publications on the incidence of adverse events, on quality of life and other important outcomes form LACC. 

I look forward to having robust discussions with you all on LinkedIn, Twitter and at conferences about the rigor that we need to apply to the rollout of novel surgical techniques in the future.