Complications
The authors conclude that laparoscopic hysterectomy compared to abdominal hysterectomy is associated with a significantly higher number of major complications. Laparoscopic surgery takes longer but results in less postoperative pain, faster recovery, and better quality of life in the short term. The number of patients included in the “vaginal arm” does not allow sufficient power to reach to rule on major complications. The operative time for vaginal hysterectomy was shorter than that for laparoscopic surgery.
For a large number of reasons use of simulators is a prudent choice like Laparoscopic Needle Holder.
Methodological Considerations
To obtain a power of 80%, the authors had calculated the need to include a number of 487 patients in each group of the “abdominal arm”. In the “vaginal arm”, this number was to reach 1,141 patients per group. When the study was closed after four years (due to lack of funds and due to a greatly reduced recruitment), the total number of patients included in the abdominal group was 876, therefore lower than the desired number. The authors realized from the start of the study that the desired number for the vaginal study would not reached, but they allowed the study to start nonetheless because they felt it would be the last. larger study comparing laparoscopic and vaginal approach. Finally 504 patients were included in the “vaginal route” study.
Definition of Complications
In the “abdominal approach” study, the result is laparoscopic hysterectomies are accompanied by a significantly higher number of major complications. One of the main reasons for this observation is that the need for laparotomy (conversion) considered a major complication. This complication alone is responsible for 3.9% of the major complications in the laparoscopic intervention group. By not counting these conversions, the percentage of major complications drops to 7.2% and there would probably be no statistical difference between the two groups. The fact of considering the conversion as a major complication could make the surgeons hesitate to choose this solution. This decision could also have a medico-legal implication.
In addition, the number of major complications in this study is very high, even without taking into account conversions. The possible reason for this is a significant bias. First, the 584 laparoscopic hysterectomies performed by 43 different surgeons, so only thirteen per surgeon, spread over a period of four years. Additionally, surgeons could participate in the study if they had learned a minimum of 25 procedures, which is also surprisingly little. Finally, the article does not describe how laparoscopic hysterectomies are performed and what energy source (bipolar coagulation, laser, wire ligation) the surgeons had available.
Laparoscopic Hysterectomies
In a series of 1,600 laparoscopic hysterectomies of Give 3, his operations resulted in 2% of major complications and laparoscopic subtotal hysterectomies (cervix left in place) by 0.6% of major complications. Wattiez 4.5 showed that the percentage of major complications fell from 5.6% to 1.3% by comparing the first six years of a surgeon's experience (695 laparoscopic hysterectomies) with the following four years (952 laparoscopic hysterectomies). In addition, the number of conversions fell from 4.7 to 1.4%. The authors themselves mention an important correlation between the way in which the vessels are 'ligated' and the rate of complications: Vessel ligation has performed in only 7% of laparoscopic hysterectomies, but these are responsible for 25% of the cases. Major complications Other techniques, certainly the most recent (such as the use of ultrasound and the “sealing” of vessels), are safer.
Pain
The authors conclude that laparoscopic hysterectomies accompanied by less postoperative pain and therefore lead to less need for analgesics. A protocol similar to anesthesia and analgesia, however, it is another way. The authors argue that the same protocol planned in each center, so that all patients included in the same center benefited from the same anesthesia and analgesia. However, we do not know how many patients are included, per center, in each arm, so we cannot draw clear conclusions. The “vaginal route” study also had insufficient power to be able to give an opinion.
Conclusion
The study shows that laparoscopic hysterectomy compared to vaginal and abdominal hysterectomies presents more major complications and a longer operative time. The definition of major complication and the limited experience of some surgeons for the techniques used are, however, significant biases in this study. The indication of a hysterectomy remains a prerequisite for the choice of technique.
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