Boccardo 2009.
Methods | Single centre randomised controlled trial | |
Participants | 55 women scheduled to undergo breast conserving surgery or radical mastectomy and axillary clearance for breast cancer. 6 women dropped out after randomisation. Intervention group: n = 25. Comparison group: n = 24. Age of participants 54.07 ± 10.54 (mean ± SD). | |
Interventions | Intervention: lymphaticovenular anastomosis was performed to prevent lymphoedema formation either during primary operation if lymphatic impairment was identified in preoperative lymphoscintigraphy or later if physical treatment failed in preventing lymphoedema development and lymphoscintigraphy done at 6 months revealed impairment in lymph flow. Comparator: no preventive strategies were used. |
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Outcomes | Lymphoedema was defined as arm volume increase of 200 mL from baseline.
Percentage of arm volume increase was also reported. Reported at 1, 3, 6, 12, and 24 months. |
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Notes | Setting: S.Martino Hospital, Genoa, Italy | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind either surgeons or participants |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Regardless of who assessed outcomes, it would be very difficult to blind outcome assessment because of participant's knowledge and the presence of surgical scars. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 89% of participants were assessed at 2 years. 6 participants did not finish follow‐up to 24 months. No reasons mentioned |
Selective reporting (reporting bias) | Low risk | Outcomes reported as described in methods section |
Other bias | Low risk | Study appeared to be free of other sources of bias |