This single-center, prospective, controlled trial compares betacyanin versus conventional methods for early diagnosis and healing assessment of anastomotic leakage after rectal cancer surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
200 mL oral betacyanin solution administered daily from postoperative day 3 until discharge or confirmation of anastomotic leakage
Daily measurement of betacyanin concentration in pelvic drainage fluid for early detection of anastomotic leakage
General Surgery Center of PLA
Chongqing, Chongqing Municipality, China
Time to Diagnosis of Anastomotic Leakage
Time frame: Within 30 days after surgery
Diagnostic Performance of Betacyanin for Anastomotic Leakage
Time frame: Within 30 days after surgery
Time to Healing of Anastomotic Leakage
Time frame: Within 30 days after surgery
Incidence of Postoperative Grade III-IV Complications
Time frame: Within 30 days after surgery
Reoperation Rate
Time frame: Within 30 days after surgery
Length of Postoperative Hospital Stay
Time frame: From surgery to hospital discharge, assessed up to 30 days
30-Day Readmission Rate
Time frame: Within 30 days after hospital discharge
Cost of Anastomotic Leakage Diagnosis
Time frame: During index hospitalization, assessed up to 30 days
Total Hospitalization Cost
Time frame: During index hospitalization, assessed up to 30 days
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