Clinical trial · Interventional
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
NCT07726966CI-TRIAL-00119473not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Rectum Cancer | Rectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Betacyanin | Dietary Supplement | — | UNRESOLVED |
| Pelvic Drainage Fluid Betacyanin Assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Betacyanin + Conventional Monitoring
- description
- 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
- interventionNames
- Dietary Supplement: Betacyanin
- Diagnostic Test: Pelvic Drainage Fluid Betacyanin Assay
Primary outcomes (1)
- measure
- Time to Diagnosis of Anastomotic Leakage
- timeFrame
- Within 30 days after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.