Anastomotic Leak, Rectum Cancer
Conditions
Keywords
Early diagnosis, Healing evaluation
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.
Interventions
DIETARY_SUPPLEMENTBetacyanin
200 mL oral betacyanin solution administered daily from postoperative day 3 until discharge or confirmation of anastomotic leakage
DIAGNOSTIC_TESTPelvic Drainage Fluid Betacyanin Assay
Daily measurement of betacyanin concentration in pelvic drainage fluid for early detection of anastomotic leakage
Sponsors
Southwest Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Radiologist；Laboratory Technicians；Clinician
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Diagnosis of Anastomotic Leakage | Within 30 days after surgery |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 30-Day Readmission Rate | Within 30 days after hospital discharge |
| Cost of Anastomotic Leakage Diagnosis | During index hospitalization, assessed up to 30 days |
| Total Hospitalization Cost | During index hospitalization, assessed up to 30 days |
Countries
China
Contacts
CONTACTBo Tang, MD
CONTACTQi Zhang
Outcome results
None listed