Maas 2012.
Methods | Study design: retrospective cohort study | |
Participants | Country: Netherlands.
Number eligible: 100.
Post‐randomisation drop‐outs: 0 (0%).
Number analysed: 100.
Average age: 64 years.
Females: 26 (26%).
Stage I: 7(7%).
Stage II: 31 (31%).
Stage III: 62 (62%).
Stage IV: 0(0%).
Squamous cell carcinoma: 28 (28%).
Adenocarcinoma: 69 (69%).
Study design: Retrospective cohort study with historical control
Total follow‐up in months: not stated
ASA: ASA I or II: 38 versus 36; ASA III or IV: 12 versus 14
Location: lower third Inclusion criteria Patients undergoing transhiatal oesophagectomy for distal oesophageal cancer Exclusion criteria Patients with colon interposition |
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Interventions | Group 1: laparoscopic transhiatal oesophagectomy (N = 50). Further details: number of ports ‐ 5; minilaparotomy ‐ 7 cm periumbilical incision); drain use ‐ not stated. Group 2: open transhiatal oesophagectomy (N = 50). Further details: incision size ‐ not stated; drain use ‐ not stated. | |
Outcomes | The outcomes reported were short‐term and long‐term mortality, morbidity, long‐term recurrence, length of hospital stay, positive resection margin, and number of lymph nodes harvested. | |
Notes | Proportion of people with cancer: 100% Conversion: 9/50 (18%) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Bias due to confounding | Unclear risk |
No information Comment: There was no evidence of baseline differences between the groups. However, the sample size was not sufficient to identify baseline differences. In addition, not all confounding factors were listed in the baseline differences table (for example, no information was presented on the differences in the size of the tumours) |
Bias due to selection of participants to intervention and control | Unclear risk |
Moderate risk of bias Comment: This was a consecutive series of laparoscopic oesophagectomies where the surgeon performed all transhiatal oesophagectomies laparoscopically after January 2001. |
Bias due to differences in co‐interventions which were different between the groups | Unclear risk |
No information Comment: A historical control was used. It was not clear there were other differences in care of the patient apart from the intervention and control. |
Bias in the measurement of outcomes | High risk |
Critical risk of bias Comment: The assessment of the patients was not done blinded (author replies). |
Bias due to missing data | Low risk |
Low risk of bias Comment: All patients were included in the analysis. |
Bias in selection of the reported findings | Low risk |
Low risk of bias Comment: Mortality and morbidity were reported adequately. |