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NCT07726966
Betacyanin for Early Diagnosis and Recovery of Anastomotic Leakage After Rectal Cancer Surgery: A Single-Center, Prospective, Controlled Trial
Conditions: Rectum Cancer, Anastomotic Leak
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Southwest Hospital, China
Location: General Surgery Center of PLA Chongqing Chongqing Municipality
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07726966). StuddyBuddy aggregates publicly available trial information.