Kim 2004.
| Methods | Randomised clinical trial with parallel design Generation of the allocation sequence and allocation concealment: were not clearly described in the original article Follow‐up: adequate Duration of follow‐up: 30 days | |
| Participants | Patients who were diagnosed with gastric cancer Country: Korea Year of study: between 1 February 2001 and 31 July 2001 Number randomised: 170 Mean age (years): Group 1S (58.5 ± 7.5), Group 2S (54.9 ± 11.4); Group 1T (56.1.3 ± 10.1), Group 2T (55.9 ± 12.5). Sex (M/F): Group 1S (36/18), Group 2S (41/23); Group 1T (24/5), Group 2T (15/6). Inclusion criteria
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| Interventions | Group 1S: subtotal gastrectomy with drain (n = 55), a two‐armed closed suction drain was used
Group 2S: subtotal gastrectomy without drain (n = 63) Group 1T: total gastrectomy with drain (n = 31), two two‐armed closed suction drains were placed Group 2T: total gastrectomy without drain (n = 21) Antibiotic use: not stated All patients underwent either total or subtotal gastrectomy with D2 or more lymph node dissection depending on the extent and location of the primary tumour. A single surgeon (SHN) performed all procedures. Splenectomy was not performed unless there was suspicion of cancer involvement. Distal pancreatectomy was not performed for any of the patients in the study |
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| Outcomes | Mortality (30‐day mortality) Re‐operations Post‐operative complications Operation time Length of post‐operative hospital stay Initiation of soft diet |
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| Notes | Drains were removed when the total output < 100 ml/24 hours Patients with subtotal or total gastrectomy were analysed separately Dose of analgesic use after surgery was compared between the drain group and the no‐drain group Liquid diet was started after confirmation of return of bowl function with passage of flatus and advanced to soft diet as tolerated Patients were discharged from the hospital after tolerating soft diet for 3 to 4 days |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Unclear |
| Allocation concealment (selection bias) | Unclear risk | Unclear |
| Blinding (performance bias and detection bias) All outcomes | High risk | All procedures were performed by a single surgeon (SHN) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Yes |
| Selective reporting (reporting bias) | Low risk | Yes |
| Other bias | Low risk | Yes |