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Betacyanin for Early Diagnosis and Recovery of Anastomotic Leakage After Rectal Cancer Surgery: A Single-Center, Prospective, Controlled Trial

21. juli 2026 opdateret af: Tang Bo, Southwest Hospital, China

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400030
        • General Surgery Center of PLA
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Betacyanin + Conventional Monitoring
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
Kosttilskud: Betacyanin
200 mL oral betacyanin solution administered daily from postoperative day 3 until discharge or confirmation of anastomotic leakage
Diagnostisk test: Pelvic Drainage Fluid Betacyanin Assay
Daily measurement of betacyanin concentration in pelvic drainage fluid for early detection of anastomotic leakage

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Time to Diagnosis of Anastomotic Leakage
Tidsramme: Within 30 days after surgery
Within 30 days after surgery

Sekundære resultatmål

Resultatmål
Tidsramme
Diagnostic Performance of Betacyanin for Anastomotic Leakage
Tidsramme: Within 30 days after surgery
Within 30 days after surgery
Time to Healing of Anastomotic Leakage
Tidsramme: Within 30 days after surgery
Within 30 days after surgery
Incidence of Postoperative Grade III-IV Complications
Tidsramme: Within 30 days after surgery
Within 30 days after surgery
Reoperation Rate
Tidsramme: Within 30 days after surgery
Within 30 days after surgery
Length of Postoperative Hospital Stay
Tidsramme: From surgery to hospital discharge, assessed up to 30 days
From surgery to hospital discharge, assessed up to 30 days
30-Day Readmission Rate
Tidsramme: Within 30 days after hospital discharge
Within 30 days after hospital discharge
Cost of Anastomotic Leakage Diagnosis
Tidsramme: During index hospitalization, assessed up to 30 days
During index hospitalization, assessed up to 30 days
Total Hospitalization Cost
Tidsramme: During index hospitalization, assessed up to 30 days
During index hospitalization, assessed up to 30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Southwest Hospital, China

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. august 2026

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

31. maj 2027

Datoer for studieregistrering

Først indsendt

21. juli 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

27. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TBo20251116

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

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