Upper GI bleed: bleeding duodenal ulcer: early surgery was not clearly better than conservative management if no vessel is visible

Clinical bottom line (level 1b-)

  1. Patients with a bleeding duodenal ulcer and no visible vessel in the base who had conservative treatment compared with early surgical intervention were less likely to have surgery (NNT = 1 at unknown) .
  2. There was no clear difference in mortality.
Saperas et al: British Journal of Surgery 1987; 74: 784-786
Expires October 2002

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: university hospital, Spain

69 patients (aged 51 to 88 mean 66, 72% male) patients with GI bleeding due to a duodenal ulcer (confirmed on endoscopy) with no visible vessel in the base (arterial bleeding or a red-bluish mass protruding from the ulcer base)

Excluded if
  • visible vessel in the ulcer base - these patients had early surgery or endoscopic therapy.
  • no evidence of recent haemorrhage from duodenal ulcer
  • aged <50
  • high operative risk due to presence of two or more of the following: recent MI, respiratory, cardiac or renal failure, decompensated diabetes mellitus, prolonged steroid treatment, chronic liver disease.

Control Group: (n = 34, 34 analysed): expectant management: iv cimetidine 1200 mg daily and liquid antacids through a nasogastric tube. Patients only had surgery when bleeding persisted or recurred.
Experimental Group: (n = 35, 34 analysed): early surgery: suture of bleeding lesion plus truncal vagotomy and pyloroplasty within 4 hours of randomisation.

99% followed for ? ?to discharge

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
surgery performed unknown 11
(32.3%)		 34
(100%)		 -209%
(-403% to -90%)		 -67.7%
(-83.4% to -51.9%)		 -1
(-2 to -1)
death unknown 1
(2.94%)		 5
(14.7%)		 -400%
(-3958% to 38%)		 -11.8%
(-25.0% to 1.43%)		 -9
(NNT = 70 to infinity;
NNH = 4 to infinity)

Comments

  1. Outmoded therapeutic options.
  2. The study is too small to show any clear difference between the two strategies.

Citation

  1. Saperas E, Pique JM, Perez Ayuso R, et al: Conservative management of bleeding duodenal ulcer without a visible vessel: prospective randomized trial. British Journal of Surgery 1987; 74: 784-786
Contributor: Chris Ball and Musab Hayatli, October 1999
Reviewer:

Clinical Question.
Patient bleeding duodenal ulcer with no visible vessel
Intervention or Exposure early surgery
Comparison medical therapy
Outcome death, need for surgery