Betacyanin for Early Diagnosis and Recovery of Anastomotic Leakage After Rectal Cancer Surgery: A Single-Center, Prospective, Controlled Trial | NCT07726966

NCT07726966

Overview

NCT ID: NCT07726966
Lead Sponsor: Southwest Hospital, ChinaOTHER
Official Title: 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
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
Interventions: Betacyanin
Pelvic Drainage Fluid Betacyanin Assay

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Aug 20, 2026Estimated
Primary Completion Date: May 1, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 120Estimated
Primary Purpose: Diagnostic
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Bo Tang, MDContact
2211934029@qq.com+8613883902288

Similar Studies

Participant Group/Arms

Betacyanin + Conventional MonitoringExperimental

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