About this trial
This single-center, prospective, controlled trial compares betacyanin versus conventional methods for early diagnosis and healing assessment of anastomotic leakage after rectal cancer surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically confirmed rectal adenocarcinoma prior to surgery.
Undergoing laparoscopic anterior resection for rectal cancer.
No prophylactic diverting ileostomy.
American Society of Anesthesiologists (ASA) Physical Status Classification ≤ 3.
Disqualifiers
Prior abdominal surgery with severe intra-abdominal adhesions.
Currently participating in, or having participated within the past 6 months in, another clinical study related to rectal cancer surgery.
Preoperative complications requiring emergency surgery, including bleeding, perforation, or obstruction.
History of prior malignancy.
Trial design
Single group
Treatments tested in this trial
Betacyanin
Dietary supplement200 mL oral betacyanin solution administered daily from postoperative day 3 until discharge or confirmation of anastomotic leakage
Pelvic Drainage Fluid Betacyanin Assay
Diagnostic testDaily measurement of betacyanin concentration in pelvic drainage fluid for early detection of anastomotic leakage
Treatment groups
Trial outcomes
Primary outcomes
Time to Diagnosis of Anastomotic Leakage
Secondary outcomes
Diagnostic Performance of Betacyanin for Anastomotic Leakage
Time to Healing of Anastomotic Leakage
Incidence of Postoperative Grade III-IV Complications
Reoperation Rate
Sponsors and contacts
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