5 Safety

5 Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

5.1 Major complications were reported in 19% (16/85) of patients treated by ultra-radical surgery and 5% (5/95) of patients treated by standard surgery in a non-randomised comparative study of 180 patients (p=0.013). Major complications were reported in 12% (7) of patients with optimal cytoreduction by ultra-radical surgery, 7% (5) of patients with optimal cytoreduction by standard surgery and 8% (4) of patients with suboptimal cytoreduction, in the non‑randomised comparative study of 262 patients (denominators not reported). The rate of major perioperative complications was significantly higher in patients treated after the introduction of ultra-radical surgery than patients treated before this period in the non‑randomised comparative study of 378 patients (p=0.015). This included higher rates of infectious, gastrointestinal and haematological complications (10% compared with 4%, 4% compared with 2%, and 2% compared with 0% respectively).

5.2 Perioperative mortality was reported as 1% (2/210) for patients treated after the introduction of ultra-radical surgery and less than 1% (1/168) for patients treated before the introduction of ultra-radical surgery in the non-randomised comparative study of 378 patients. Sixty‑day mortality was 3% (3/88) for patients with complete cytoreduction by ultra-radical surgery, 0% (0/38) for patients with complete cytoreduction by standard surgery and 6% (8/141) for patients with incomplete cytoreduction in the non‑randomised comparative study of 267 patients. Thirty‑day mortality was 1% (2/141) in a case series of 141 patients.

5.3 Bleeding that required reoperation was reported in 2% (3/141) of patients in the case series of 141 patients.

5.4 Postoperative temperature over 38°C for more than 3 days was reported in 17% (15/88) of patients treated by ultra-radical surgery and 5% (2/38) of patients treated by standard surgery in the non‑randomised comparative study of 267 patients.

5.5 Symptomatic pleural effusion needing drainage was reported in 9% (12/141) of patients in the case series of 141 patients.

5.6 Pancreatic leak needing drainage was reported in 3% (4/141) of patients in the case series of 141 patients.

5.7 Additional anecdotal adverse events listed by the specialist advisers included pneumothorax, and injury to large blood vessels, the bowel, the urinary tract and nerves. They stated that theoretical adverse events were anastomotic leak and fistulae. The specialist advisers stated that delay in starting chemotherapy was an additional adverse event reported in the literature.

  • National Institute for Health and Care Excellence (NICE)