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Not yet recruiting NCT07726966

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

No phase Interventional Rectum Cancer Anastomotic Leak

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Betacyanin, Pelvic Drainage Fluid Betacyanin Assay.
Who it may be relevant to
Registry conditions: Rectum Cancer, Anastomotic Leak. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • 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

Primary outcome measures

  • Time to Diagnosis of Anastomotic Leakage [Time frame: Within 30 days after surgery]
Secondary outcome measures (8)
  • Diagnostic Performance of Betacyanin for Anastomotic Leakage [Time frame: Within 30 days after surgery]
  • Time to Healing of Anastomotic Leakage [Time frame: Within 30 days after surgery]
  • Incidence of Postoperative Grade III-IV Complications [Time frame: Within 30 days after surgery]
  • Reoperation Rate [Time frame: Within 30 days after surgery]
  • Length of Postoperative Hospital Stay [Time frame: From surgery to hospital discharge, assessed up to 30 days]
  • 30-Day Readmission Rate [Time frame: Within 30 days after hospital discharge]
  • Cost of Anastomotic Leakage Diagnosis [Time frame: During index hospitalization, assessed up to 30 days]
  • Total Hospitalization Cost [Time frame: During index hospitalization, assessed up to 30 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • General Surgery Center of PLA — Chongqing

Identifiers

NCT: NCT07726966 · TBo20251116

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗