Betacyanin for Early Diagnosis and Recovery of Anastomotic Leakage After Rectal Cancer Surgery: A Single-Center, Prospective, Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSouthwest Hospital, China

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Betacyanin

    Dietary supplement

    200 mL oral betacyanin solution administered daily from postoperative day 3 until discharge or confirmation of anastomotic leakage

  • Pelvic Drainage Fluid Betacyanin Assay

    Diagnostic test

    Daily measurement of betacyanin concentration in pelvic drainage fluid for early detection of anastomotic leakage

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Betacyanin + Conventional MonitoringExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Time to Diagnosis of Anastomotic Leakage

Time frame
Within 30 days after surgery

Secondary outcomes

1

Diagnostic Performance of Betacyanin for Anastomotic Leakage

Time frame
Within 30 days after surgery
2

Time to Healing of Anastomotic Leakage

Time frame
Within 30 days after surgery
3

Incidence of Postoperative Grade III-IV Complications

Time frame
Within 30 days after surgery
4

Reoperation Rate

Time frame
Within 30 days after surgery

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: