Marsh 1994.
Methods | Randomisation method not available. Enrolment period: 1982 to 1986 Abdominal imaging: not stated Chest imaging: not stated Study arm: 143 randomised, 0 excluded; median time from randomisation to surgery 27 days (IQR 21 to 33) Control arm: 141 randomised , 0 excluded; median time from randomisation to surgery 19 days (IQR 12 to 26) | |
Participants | Rectal cancer Location: </= 13 cm Resectability: locally advanced (tethered or fixed) but operable (within 13 cm of the anal verge) | |
Interventions | Surgery: not stated RT: 2000 in 4 fr BED: 31.8 Gy10 RT volume: 10x10x10 cm posterior pelvis RT‐S: </= 1 week Technique: rotational field Co‐intervention: none | |
Outcomes |
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Notes | Definition for:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | It was unclear how the method of randomisation was performed. |
Allocation concealment (selection bias) | Unclear risk | It was unclear how allocation of participants was concealed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding is not possible with the type of intervention. |
Blinding the outcome assessor (detection bias; objective outcomes) Outcomes: mortality; local recurrence; distant metastases; curative resection Outcomes: mortality; local recurrence; distant metastases; any recurrence; curative resection | Low risk | Mortality: no information was provided on the blinding of the outcome evaluator. Recurrence: no information was provided on the blinding of the outcome evaluator. Metastases: no information was provided on the blinding of the outcome evaluator. Curative resection: It was unclear whether the operating surgeon or the pathologist was blinded. Quote: "The operating surgeon recorded a 'curative' resection if the carcinoma was removed with neither spillage nor perforation, and there was no macroscopic evidence of residua I local disease or distant metastases. The degree of local invasion present at operation was also noted. Pathologic information on the resected tumour was recorded prospectively by pathologists from the referral hospital on a standard form for each of the 284 patients. Lymph nodes were sampled and assessed in the normal way, as was the presence of venous invasion." Since the outcomes were objective, we considered the study to be at low risk of detection bias for the listed outcomes. |
Blinding the outcome assessor (detection bias): subjective outcomes: Postoperative morbidity; sphincter preservation; acute and late toxicities; quality of life Outcomes: Postoperative morbidity; sphyncter preservation | Unclear risk | Postoperative morbidity was not assessed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Although intention‐to‐treat was not stated, it appears that all participants were analysed according to their initial allocation. No apparent significant loss to follow‐up |
Selective reporting (reporting bias) | Low risk | Relevant clinical outcomes were considered. |