eVALuate

Question 1

eVALuate study:
Name 
Title
Study Type
Population

Answer 1

Garry 2004
The eVALuate study: 2 parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, and one comparing laparoscopic  with vaginal hysterectomy
2 parallel, multicentre randomised trials, (unbalanced randomisation 2:1)
Population
	- 1380women recruited
	- 1346 had surgery
	- 937 followed up at one year
- Mostly UK, but also SA

Question 2

eVALuate study:

Primary outcome

Answer 2

eVALuate:
Primary outcome:
- Rate of major complications
Haemorrhage req RBC, haematoma, bowel/ureteric/bladder injury, PE, anaesthetic problem, wound dehiscence

Question 3

eVALuate
Results
Take home messages

Answer 3

eVALuate
Results:
TAH vs TLH
Rate of major complications
11.1% vs 6.2% p=0.02 (NNT to harm was 20)
Length of surgery 50mins vs 84mins
Pain More TAH Less TLH p=0.01 Measured with visual analogue score
Length of hospital stay 4 days TAH 3 days TLH
Quality of life at 6 weeks Worse TAH Better TLH Multiple questionnaires

Take home message:
- TLH has more major complications than TAH and took longer to perform
- BUT
○ Was less painful
○ Shorter hospital stay
○ Better quality of life at 6 weeks.
- Vaginal hysterectomy was the quickest (39 mins) and there was no difference in complication rate.
Laparoscopy had a higher rate of detecting unexpected pathology than vaginal. (but no data on how this effected outcomes

Question 4

eVALuate:

Criticisms

Answer 4

eVALuate:
Criticisms
- Vaginal arm was underpowered
- Limited generalisability as many common indications for malignancy were excluded. For example: malignancy, severe prolapse, >12 week size uterus, medical illness precluding laparoscopy.
- A major complication was unintended laparotomy (which TAH was not subject to), and this was one of the highest causes of ‘complication’
- Assume that skill in laparoscopy has improved overall since trial was published.
Subjective outcome used (QoL and pain)