- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03776370
Preserving Left Colonic Artery During Radical Resection of Rectal Cancer
28. april 2022 opdateret af: Weidong Tong, Third Military Medical University
A Clinical Cohort Study on the Effect of Preserving Left Colonic Artery During Radical Resection of Rectal Cancer on Anastomotic Leakage and Oncology Efficacy
To evaluate the feasibility and clinical significance of preserving left colonic artery in rectal cancer surgery.The investigators will focus on the effect of preserving left colonic artery during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The investigators performed three-dimensional (3D) reconstruction to investigate the vascular anatomy, including the inferior mesenteric artery (IMA) and left colic artery (LCA),to help make pre-operative strategies of rectal cancer surgery.The investigators will preserving the left colonic artery during rectal cancer surgery and evaluate its feasibility and clinical significance.The investigators will focus on the effect of preserving left colonic artery during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
200
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Chongqing
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Chongqing, Chongqing, Kina, 400000
- zongming,Kang
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Yuzhong, Chongqing, Kina, 400000
- zongming,Kang
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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
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients who underwent laparoscopic or robotic anterior rectal resections carried out by two surgeons at Daping Hospital.
Beskrivelse
Inclusion Criteria:
- Pathological biopsy confirmed adenocarcinoma of the rectum;
- Preoperative assessment of tolerance to surgery without major organ dysfunction;
- Patients must be able to understand and voluntarily sign written informed consent;
- The surgical method is laparoscopic or robotic anterior rectal cancer resection.
Exclusion Criteria:
- The patient cannot tolerate the operation;
- Refusal to sign informed consent;
- Patients with distant metastasis of rectal cancer;
- The surgical method was changed to miles or Hartman;
- Unable to complete the follow - up
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Preserve the left colonic artery
Preservation of left colonic artery in rectal cancer surgery.
|
Preservation of left colonic artery in rectal cancer surgery.
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The left colonic artery is not preserved
The left colonic artery was dissected in rectal cancer surgery
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The left colonic artery was dissected in rectal cancer surgery.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The incidence of postoperative anastomotic leakage was compared between the two groups.
Tidsramme: Within 30 days after surgery
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The incidence of anastomotic leakage within 30 days after surgery was compared between the intervention group and the control group.
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Within 30 days after surgery
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The distant metastasis rates of rectal cancer between the two groups were compared.
Tidsramme: Two years after surgery
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The incidence of distant metastasis rectal cancer within two years after surgery was compared between the intervention group and the control group.
|
Two years after surgery
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The local recurrence rates of rectal cancer between the two groups were compared.
Tidsramme: Two years after surgery
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The incidence of local recurrence rectal cancer within two years after surgery was compared between the intervention group and the control group.
|
Two years after surgery
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The five-year survival rates of rectal cancer between the two groups were compared.
Tidsramme: Five years after surgery
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The 5-year survival rates of rectal cancer in the intervention group and the control group were compared.
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Five years after surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Wei d tong, PhD, Army Military Medical University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Fan YC, Ning FL, Zhang CD, Dai DQ. Preservation versus non-preservation of left colic artery in sigmoid and rectal cancer surgery: A meta-analysis. Int J Surg. 2018 Apr;52:269-277. doi: 10.1016/j.ijsu.2018.02.054. Epub 2018 Mar 1.
- Sekimoto M, Takemasa I, Mizushima T, Ikeda M, Yamamoto H, Doki Y, Mori M. Laparoscopic lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery. Surg Endosc. 2011 Mar;25(3):861-6. doi: 10.1007/s00464-010-1284-7. Epub 2010 Aug 20.
- Zheng H, Li F, Xie X, Zhao S, Huang B, Tong W. Preservation versus nonpreservation of the left colic artery in anterior resection for rectal cancer: a propensity score-matched analysis. BMC Surg. 2022 May 10;22(1):164. doi: 10.1186/s12893-022-01614-y.
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 (Faktiske)
1. december 2018
Primær færdiggørelse (Faktiske)
1. januar 2022
Studieafslutning (Faktiske)
1. januar 2022
Datoer for studieregistrering
Først indsendt
9. december 2018
Først indsendt, der opfyldte QC-kriterier
11. december 2018
Først opslået (Faktiske)
14. december 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. maj 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. april 2022
Sidst verificeret
1. april 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20181155
Plan for individuelle deltagerdata (IPD)
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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