Upper GI bleed: bleeding duodenal ulcer: gastrectomy prevented rebleeding and reoperation better than oversewing and vagotomy

Clinical bottom line (level 2b)

  1. Patients with bleeding duodenal ulcers who had a gastrectomy compared with oversewing and a vagotomy were less likely to rebleed (NNT = 7 at 4 weeks) or require further surgery (NNT = 8 at 4 weeks) .
  2. Patients who have a gastrectomy were more likely to have a duodenal leak (NNH = 10 at 4 weeks) .
  3. There was no clear effect on mortality
Millat et al: World Journal of Surgery 1993; 17 (5): 568-574
Expires October 2002

The study

Unblinded ?concealed quasi-randomised trial without intention-to-treat
Setting: 22 acute hospitals, France

120 patients (aged 18 to 85; mean 61, 65% male) with an upper GI bleed from a bulbar duodenal ulcer seen on endoscopy, and massive haemorrhage (presence of clinical shock on admission requiring permanent high-rate transfusion to stabilise blood pressure); persistent haemorrhage (requiring >6 units in 4 days); or recurrent haemorrhage (within first week causing a fall of >40 mmHg or haematocrit <30%)

Excluded if
  • poor operative risk
  • aged <18
  • previously undergone surgical treatment for gastroduodenal disease
  • no endoscopic signs of active or recent bleeding
  • gastric or postbulbar duodenal ulcers
  • acute gastroduodenal ulcerations


  • Note:
  • Patients were stratified for age, sex and presence of liver cirrhosis before randomisation.

Control Group: (n = 59, 58 analysed): gastric resection of the distal two-thirds of the stomach with complete excision of the anterior ulcer and the margins of the posterior ulcer +/- truncal vagotomy with antrectomy
Experimental Group: (n = 61, 60 analysed): oversewing of ulcer plus truncal vagotomy and drainage
Patients were operated on by senior residents or staff surgeons.
98% followed for 4 weeks
Outcome notes:
  • rebleeding : diagnosed by endoscopy or reoperation and requiring at least 1 unit of blood

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)
ARR
(95% CI)
NNT
(95% CI)
rebleeding 4 weeks 10
(17.2%)
2
(3.33%)
81%
(16% to 96%)
13.91%
(3.18% to 24.64%)
7
(4 to 31)
duodenal leaks 4 weeks 2
(3.45%)
8
(13.3%)
-287%
(-1645% to 14%)
-9.89%
(-19.68% to -0.09%)
-10
(-1174 to -5)
post-operative mortality 4 weeks 13
(22.4%)
14
(23.3%)
-4%
(-102% to 46%)
-0.92%
(-16.08% to 14.24%)
-109
(NNT = 6 to infinity;
NNH = 7 to infinity)
reoperations 4 weeks 8
(13.8%)
1
(1.67%)
88%
(6% to 98%)
12.13%
(2.68% to 21.57%)
8
(5 to 37)

Citation

  1. Millat B, Hay J-M, Valleur P, et al: Emergency surgical treatment for bleeding duodenal ulcer: oversewing plus vagotomy versus gastric resection, a controlled randomized trial. World Journal of Surgery 1993; 17 (5): 568-574
Contributor: Chris Ball and Musab Hayatli, October 1999
Reviewer:

Clinical Question.
Patient bleeding duodenal ulcer
Intervention or Exposure oversewing and vagotomy
Comparison gastrectomy
Outcome rebleeding, reoperation, death