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

A Single - Center, Prospective,Controlled Clinical Trial Exploring the Function of Betacyanin in the Early Diagnosis and Subsequent Recovery From Anastomotic Leakage After Rectal Cancer Surgery

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 Overview

• Status: Not yet recruiting
• Conditions: Anastomotic Leak; Rectum Cancer
• Intervention / Treatment: Dietary supplement: Betacyanin; Diagnostic test: Pelvic Drainage Fluid Betacyanin Assay

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bo Tang, MD; Phone Number: +8613883902288; Email: 2211934029@qq.com
• Study Contact Backup: Name: Qi Zhang; Phone Number: +8613508876528; Email: 502384305@qq.com

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • General Surgery Center of PLA
      • Contact: Bo Tang, MD; Phone Number: +8613883902288; Email: 2211934029@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Pathologically confirmed rectal adenocarcinoma prior to surgery.
2. Undergoing laparoscopic anterior resection for rectal cancer.
3. No prophylactic diverting ileostomy.
4. American Society of Anesthesiologists (ASA) Physical Status Classification ≤ 3.
5. No prior history of malignant tumors, and no evidence of other malignancies on preoperative examination.
6. Written informed consent obtained from the patient or a legally authorized representative.

Exclusion Criteria:

1. Prior abdominal surgery with severe intra-abdominal adhesions.
2. Currently participating in, or having participated within the past 6 months in, another clinical study related to rectal cancer surgery.
3. Preoperative complications requiring emergency surgery, including bleeding, perforation, or obstruction.
4. History of prior malignancy.
5. Undergoing Parks procedure with anastomosis at the anal verge, or Miles procedure, or Hartmann's procedure.
6. Preoperative neoadjuvant chemoradiotherapy, or presence of other high-risk factors for anastomotic leakage requiring a prophylactic diverting ileostomy.
7. ASA Physical Status Classification > 3.
8. Patient withdrawal of consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Betacyanin + Conventional Monitoring; All eligible patients who undergo rectal cancer resection will receive the same intervention and monitoring protocol. Starting from postoperative day 3, each patient will orally consume 200 mL of betacyanin solution daily (concentration and formulation as specified in the study protocol). Concurrently, pelvic drainage fluid will be collected daily to measure betacyanin concentration as a potential biomarker for early detection of anastomotic leakage. In parallel, conventional diagnostic methods for anastomotic leakage-including clinical symptom assessment, routine laboratory tests (e.g., white blood cell count, C-reactive protein), and imaging studies when clinically indicated-will be performed on the same patients at the same time points. Thus, each patient serves as his/her own control, allowing a direct comparison of diagnostic accuracy and healing evaluation between betacyanin-based monitoring and conventional approaches. The intervention and monitoring will continue daily until h

Dietary supplement: Betacyanin; 200 mL oral betacyanin solution administered daily from postoperative day 3 until discharge or confirmation of anastomotic leakage; Diagnostic test: Pelvic Drainage Fluid Betacyanin Assay; Daily measurement of betacyanin concentration in pelvic drainage fluid for early detection of anastomotic leakage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to Diagnosis of Anastomotic Leakage	Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Diagnostic Performance of Betacyanin for Anastomotic Leakage	Within 30 days after surgery
Time to Healing of Anastomotic Leakage	Within 30 days after surgery
Incidence of Postoperative Grade III-IV Complications	Within 30 days after surgery
Reoperation Rate	Within 30 days after surgery
Length of Postoperative Hospital Stay	From surgery to hospital discharge, assessed up to 30 days
30-Day Readmission Rate	Within 30 days after hospital discharge
Cost of Anastomotic Leakage Diagnosis	During index hospitalization, assessed up to 30 days
Total Hospitalization Cost	During index hospitalization, assessed up to 30 days

Collaborators and Investigators

• Sponsor: Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Early diagnosis; Healing evaluation
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Pathological Conditions, Signs and Symptoms; Rectal Neoplasms; Disease; Anastomotic Leak; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Alkaloids; Amines; Piperidines; Amino Acids; Quaternary Ammonium Compounds; Onium Compounds; Amino Acids, Aromatic; Amino Acids, Cyclic; Tyrosine; Betalains; Betacyanins
• Other Study ID Numbers: TBo20251116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No