An interventional study of Betacyanin and Pelvic Drainage Fluid Betacyanin Assay in Rectum Cancer and Anastomotic Leak, sponsored by Southwest Hospital, China. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Southwest Hospital, China · Not applicable, Interventional, and Diagnostic
This single-center, prospective, controlled trial compares betacyanin versus conventional methods for early diagnosis and healing assessment of anastomotic leakage after rectal cancer surgery.
2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.
This study's planned enrollment of 120 is above the median of 65 across 1,751 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Southwest Hospital, China is the lead sponsor of 87 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
200 mL oral betacyanin solution administered daily from postoperative day 3 until discharge or confirmation of anastomotic leakage
Daily measurement of betacyanin concentration in pelvic drainage fluid for early detection of anastomotic leakage
Time to Diagnosis of Anastomotic Leakage
Time frame: Within 30 days after surgery
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
Plan to share: Undecided
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Southwest Hospital, China