eVALuate trial of complications of hysterectomy

	Abdominal trial		Vaginal Trial
	Abdominal hysterectomy (n = 292)	Laparoscopic hysterectomy (n = 584)	Vaginal hysterectomy (n = 168)	Laparoscopic hysterectomy (n = 336)
Major hemorrhage	7* (2.4)	27* (4.6)	5 (2.9)	17 (5.1)
Bowel injury	3 (1)	1 (0.2)	0	0
Ureteric injury	0	5 (0.9)	0	1 (0.3)
Bladder injury	3 (1)	12* (2.1)	2 (1.2)	3 (0.9)
Intraoperative conversion	1^¶ (0.3)	23 (3.9)	7 (4.2)	9 (2.7)
Wound dehiscence	1 (0.3)	1(0.2)	0	1 (0.3)
Hematoma	2 (0.7)	4 (0.7)	2 (1.2)	7 (2.1)
At least one major complication	18 (6.2)	65 (11.1)	16 (9.5)	33 (9.8)

A patient may have more than one complication.

* These patients converted procedure before the operation: one patient undergoing abdominal hysterectomy converted to laparoscopic hysterectomy before the operation in the abdominal trial and had a major hemorrhage. Two patients in the abdominal trial who were undergoing laparoscopic hysterectomy converted to abdominal hysterectomy before the operation and had a major hemorrhage. One patient undergoing laparoscopic hysterectomy in the abdominal trial converted to abdominal hysterectomy before the operation and had a major anesthetic problem. One patient undergoing laparoscopic hysterectomy in the abdominal trial converted to abdominal hysterectomy before the operation and had a bladder injury.
¶ This patient in the abdominal trial was randomized to abdominal hysterectomy, converted to laparoscopic hysterectomy before the operation and then converted back to abdominal hysterectomy during the operation.

Adapted from Garry R, Fountain J, Mason S, et al. The eVALuate study: Two parallel randomized trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. BMJ 2004; 328:129.

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eVALuate trial of complications of hysterectomy