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document
Diverting stoma after low anterior resection : more arguments in favor . PURPOSE The necessity of a protective stoma in patients undergoing low anterior resection with total mesorectal excision for primary rectal cancer is discussed controversially . We conducted a randomized , controlled , pilot-study to evaluate the need for diverting ileostomy in patients undergoing low anterior resection [ NCT00457327 ] . METHODS Forty patients after elective sphincter-saving low anterior resection were eligible for intraoperative randomization . The primary objective of this trial was to demonstrate similar risks after the resection with both techniques . A priori stopping rules were defined for early termination of the trial . RESULTS Between July 4 , 2006 and March 12 , 2007 , a total of 41 patients were screened and 34 patients were randomized . Eighteen patients were randomized to the stoma group and 16 patients to the nonstoma group The symptomatic anastomotic leakage rate was significantly higher in the nonstoma group ( 37.5 percent ) than in the stoma group ( 5.5 percent , P = 0.02 ) . In all six cases in the nonstoma group , reoperations were necessary . The study was stopped after 34 patients were included . A meta-analysis of the available data confirmed the value of a protective ostomy for patients undergoing low anterior resection . CONCLUSIONS The data demonstrate a high risk for patients undergoing low anterior resection without diverting ileostomy .
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Intervention_Physical
protective stoma
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Intervention_Surgical
low anterior resection
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Intervention_Surgical
stoma group
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Intervention_Physical
nonstoma group
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Outcome_Physical
Diverting stoma
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Outcome_Physical
diverting ileostomy
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Outcome_Adverse-effects
similar risks
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Outcome_Physical
The symptomatic anastomotic leakage rate
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Outcome_Physical
reoperations
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Participant_Condition
primary rectal cancer
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Participant_Sample-size
Forty
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Participant_Condition
elective sphincter-saving low anterior resection
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Participant_Sample-size
34
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Participant_Sample-size
Eighteen
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Participant_Sample-size
16
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Participant_Condition
anterior resection