Rectum CancerNCT07726966
Betacyanin for Early Diagnosis and Recovery of Anastomotic Leakage After Rectal Cancer Surgery: A Single-Center, Prospective, Controlled Trial
A study testing Betacyanin and Pelvic Drainage Fluid Betacyanin Assay in people with Rectum Cancer and Anastomotic Leak, run by Southwest Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectum Cancer, Anastomotic Leak
- What is being tested?
- Betacyanin and Pelvic Drainage Fluid Betacyanin Assay
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
General Surgery Center of PLA
Chongqing, Chongqing Municipality, 400030
Bo Tang, MD, +8613883902288, 2211934029@qq.com
About this study
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
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
- Rectum Cancer, Anastomotic Leak
- Being tested
- Betacyanin, Pelvic Drainage Fluid Betacyanin Assay
- Keywords
- Early diagnosis, Healing evaluation
- Medical subject headings
- Rectal Neoplasms, Anastomotic Leak, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetacyaninDietary supplement
200 mL oral betacyanin solution administered daily from postoperative day 3 until discharge or confirmation of anastomotic leakage
Pelvic Drainage Fluid Betacyanin AssayDiagnostic test
Daily measurement of betacyanin concentration in pelvic drainage fluid for early detection of anastomotic leakage
| Study group | Role | What they receive |
|---|---|---|
| Betacyanin + Conventional Monitoring | Experimental | 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 Receives: Dietary Supplement: Betacyanin; Diagnostic Test: Pelvic Drainage Fluid Betacyanin Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Diagnosis of Anastomotic Leakage
Measured: Within 30 days after surgery
Secondary outcomes (8)
Diagnostic Performance of Betacyanin for Anastomotic Leakage
Measured: Within 30 days after surgery
Time to Healing of Anastomotic Leakage
Measured: Within 30 days after surgery
Incidence of Postoperative Grade III-IV Complications
Measured: Within 30 days after surgery
Reoperation Rate
Measured: Within 30 days after surgery
Length of Postoperative Hospital Stay
Measured: From surgery to hospital discharge, assessed up to 30 days
30-Day Readmission Rate
Measured: Within 30 days after hospital discharge
Cost of Anastomotic Leakage Diagnosis
Measured: During index hospitalization, assessed up to 30 days
Total Hospitalization Cost
Measured: During index hospitalization, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start20 Aug 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectum CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tang Bo, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726966
- Sponsor's protocol ID
- TBo20251116
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07726966
- Acronym / sponsor ID
- TBo20251116
- Conditions
- Rectum Cancer, Anastomotic Leak
- Keywords
- Early diagnosis, Healing evaluation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center, prospective, controlled trial compares betacyanin versus conventional methods for early diagnosis and healing assessment of anastomotic leakage after rectal cancer surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Betacyanin + Conventional Monitoring | Experimental | Dietary Supplement: Betacyanin, Diagnostic Test: Pelvic Drainage Fluid Betacyanin AssayAll 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betacyanin200 mL oral betacyanin solution administered daily from postoperative day 3 until discharge or confirmation of anastomotic leakage | Dietary supplement | Betacyanin + Conventional Monitoring |
| Pelvic Drainage Fluid Betacyanin AssayDaily measurement of betacyanin concentration in pelvic drainage fluid for early detection of anastomotic leakage | Diagnostic test | Betacyanin + Conventional Monitoring |
Primary outcome
Time to Diagnosis of Anastomotic Leakage
Time frame: Within 30 days after surgery
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betacyanin and Pelvic Drainage Fluid Betacyanin Assay in people with Rectum Cancer and Anastomotic Leak, run by Southwest Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Tang, MD (+8613883902288, 2211934029@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Diagnosis of Anastomotic Leakage (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.