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

NCT07726966 | Not Yet Recruiting DMC

• 1 other identifier: TBo20251116
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, prospective, controlled trial compares betacyanin versus conventional methods for early diagnosis and healing assessment of anastomotic leakage after rectal cancer surgery.

Conditions

Rectum Cancer; Anastomotic Leak

Keywords

Early diagnosis; Healing evaluation

Outcome Measures

Primary Outcomes (1)

• Time to Diagnosis of Anastomotic Leakage

  Within 30 days after surgery

Secondary Outcomes (8)

• 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

Study Arms (1)

Betacyanin + Conventional Monitoring

EXPERIMENTAL

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; Diagnostic Test: Pelvic Drainage Fluid Betacyanin Assay

Interventions

Betacyanin DIETARY_SUPPLEMENT

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

Betacyanin + Conventional Monitoring

Pelvic Drainage Fluid Betacyanin Assay DIAGNOSTIC_TEST

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

Betacyanin + Conventional Monitoring

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• No prior history of malignant tumors, and no evidence of other malignancies on preoperative examination.
• Written informed consent obtained from the patient or a legally authorized representative.

You may not qualify if:

• 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.
• Undergoing Parks procedure with anastomosis at the anal verge, or Miles procedure, or Hartmann's procedure.
• Preoperative neoadjuvant chemoradiotherapy, or presence of other high-risk factors for anastomotic leakage requiring a prophylactic diverting ileostomy.
• ASA Physical Status Classification \> 3.
• Patient withdrawal of consent.

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

General Surgery Center of PLA

Chongqing, Chongqing Municipality, 400030, China

Location

MeSH Terms

Conditions

Rectal Neoplasms; Anastomotic Leak; Disease

Interventions

Betacyanins

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Betalains; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Alkaloids; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Bo Tang, MD

CONTACT

+8613883902288; 2211934029@qq.com

Qi Zhang

CONTACT

+8613508876528; 502384305@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Radiologist；Laboratory Technicians；Clinician
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 27, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

CN (1)