Fram 2002.
Methods | Randomised controlled trial Study dates: July 1996 to July 1998 (24 months) |
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Participants | 61 women randomised 32 in laparotomy group, mean age 60.6 years, BMI 26.2, stages not documented, histology not documented (SD not documented). 29 in laparoscopy group, mean age 61.2 years, BMI 25.7, stages not documented, histology not documented (SD not documented). Inclusion criteria: stage I EC Exclusion criteria: not documented |
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Interventions |
Intervention: LAVH, bilateral salpingo‐oophorectomy, peritoneal washings, ± pelvic lymph node dissection (node dissection described in detail). Control: laparotomy, TAH, bilateral salpingo‐oophorectomy, peritoneal washings, ± pelvic lymph node dissection. Procedure described as "traditional approach", no further details given. Number of surgeons who performed procedures/level of experience: not documented. |
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Outcomes | Days of hospitalisation Duration of procedure Intraoperative bleeding Complications Conversion from laparoscopy to laparotomy |
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Notes | Follow‐up: period of follow‐up and loss to follow‐up rate not documented. Analysis: no comment on study power, no comment on ITT analysis. Final stage and histopathological characteristics: not documented. There was a significant difference (P < 0.05) in days of hospitalisation between the laparoscopic (group A) and laparotomy (group B) groups (2.3 vs 5.5 days). Laparoscopy was associated with longer operating time (136.2 min vs 101.9 min) (P < 0.05). There was no significant difference in the number of lymph nodes obtained in both groups of participants who required pelvic lymphadenectomy, neither on each side alone nor in total (21.3 in laparoscopy group vs. 21.9 in laparotomy group), and it was noted that the number of lymph nodes obtained from the right sides of participants were more than those obtained from the left sides in both groups (11.9 in laparoscopy group vs 12.2 in laparotomy group on the right side, and 9.4 in laparoscopy group vs 9.7 in laparotomy group on the left side). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Concerns regarding this study being a randomised controlled trial, despite the use of the phrase "the patients were randomly allocated into two groups", as there was little documentation regarding method of randomisation and study methodology. The phrase "there were 32 patients in group B who were matched as a control group" implies a case controlled study. |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No documentation regarding completeness of data. No information on attrition. No comment on cases included for analysis. |
Selective reporting (reporting bias) | Unclear risk | insufficient information to permit judgement. |
Other bias | Unclear risk | insufficient information to assess whether additional form of bias may have been present. |