Jeremy Hawe | PubMed Health

PubMed2004

The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy.

OBJECTIVE: To compare the effects of laparoscopic hysterectomy and abdominal hysterectomy in the abdominal trial, and laparoscopic hysterectomy and vaginal hysterectomy in the vaginal trial. DESIGN: Two parallel, multicentre, randomised trials. SETTING: 28 UK centres and two South African centres. PARTICIPANTS: 1380 women were recruited; 1346 had surgery; 937 were followed up at one year. Primary outcome Rate of major complications. RESULTS: In the abdominal trial laparoscopic hysterectomy was associated with a higher rate of major complications than abdominal hysterectomy (11.1% v 6.2%, P = 0.02; difference 4.9%, 95% confidence interval 0.9% to 9.1%) and the number needed to treat to harm was 20. Laparoscopic hysterectomy also took longer to perform (84 minutes v 50 minutes) but was less painful (visual analogue scale 3.51 v 3.88, P = 0.01) and resulted in a shorter stay in hospital after the operation (3 days v 4 days). Six weeks after the operation, laparoscopic hysterectomy was associated with less pain and better quality of life than abdominal hysterectomy (SF-12, body image scale, and sexual activity questionnaires). In the vaginal trial we found no evidence of a difference in major complication rates between laparoscopic hysterectomy and vaginal hysterectomy (9.8% v 9.5%, P = 0.92; difference 0.3%, -5.2% to 5.8%), and the number needed to treat to harm was 333. We found no evidence of other differences between laparoscopic hysterectomy and vaginal hysterectomy except that laparoscopic hysterectomy took longer to perform (72 minutes v 39 minutes) and was associated with a higher rate of detecting unexpected pathology (16.4% v 4.8%, P = < 0.01). However, this trial was underpowered. CONCLUSIONS: Laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy. It also took longer to perform but was associated with less pain, quicker recovery, and better short term quality of life. The trial comparing vaginal hysterectomy with laparoscopic hysterectomy was underpowered and is inconclusive on the rate of major complications; however, vaginal hysterectomy took less time.

Adult↗

PubMed2003

In-vitro and in-vivo histochemical and thermal studies using a thermal balloon endometrial ablation system for varying treatment times.

BACKGROUND: To assess the immediate zone of thermal necrosis (ZTN) using an enzyme histochemical staining technique and serosal temperatures for the Cavaterm endometrial balloon ablation system for different treatment times. METHODS: A thermal balloon ablation was performed initially post- (n = 6) and subsequently pre-hysterectomy (n = 15). Eight to 12 tissue blocks from each uterus were sectioned and stained using diaphorase respiratory enzyme techniques. Patients in the in-vivo group had temperature measurements taken from four serosal points, a myometrial gradient profile, the balloon surface and the endocervical canal. RESULTS: The serosal temperature sensors did not demonstrate any rise in temperature above 44.1 degrees C. The mean temperature at the anterior wall, posterior wall, fundus and cornual areas was 37.1 (SD 1.3), 36.8 (SD 1.0), 37.4 (SD 1.8) and 36.7 degrees C (SD 1.0), respectively. The immediate mean maximum ZTN was greatest for the 15-min treatment time (3.1 mm, SD 1.5) compared to the 10- and 7-min treatment times (3.0 mm, SD 1.4 and 2.2 mm, SD 0.7, respectively). The maximum ZTN recorded was 5.6 mm. No full thickness injuries were demonstrated either histochemically or suggested by the temperature studies. CONCLUSIONS: This study confirms that Cavaterm thermal balloon ablation produces a reproducible thermal injury without evidence of serosal heating. Results suggest that the treatment time could be reduced to 10-min with no detrimental effect on the clinical outcomes. This hypothesis is currently being evaluated by clinical trials.

Female↗