Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis. (LACC)
30 november 2020 uppdaterad av: Francesca Cravero, Santo Spirito Hospital, Italy
Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis. (LACC Trial)
The aim of the present study is to assess the post-operative outcomes (morbidity and mortality) in relation to preoperative data and the oncological outcomes (overall and disease-free survival) in patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).
Studieöversikt
Status
Okänd
Intervention / Behandling
Detaljerad beskrivning
All patients that meet the inclusion criteria will be registered in a retrospective database from 2014 to 2019 (5 years) Data will be reported for every patients with colon cancer to have had either a resection of another organ or structure in addition to resection of the primary tumor, or to have had a T4 (a or b) tumour on postoperative histopathology.
Data included are patient demographics, ASA score, tumor localization, preoperative imaging, neoadjuvant treatments, type of bowel resection and adjacent organs resected, tecnique (laparoscopic/laparotomic), postoperative complications and 30-day mortality, histopathology data including TNM scoring, completeness of surgical procedure (R0 to R2) and infiltration of tumor cells in resected tissues, adjuvant oncological treatments, and long term follow-up data on local and distant recurrence and survival.
Studietyp
Observationell
Inskrivning (Förväntat)
100
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).
Beskrivning
Inclusion criteria
- > 18 aa
- Patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).
Exclusion criteria
- Stage IV
- Rectal cancer
- Emergency surgery (<48 hours from admission)
- ASA > III
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative morbidity
Tidsram: 30 days
|
I evaluate peri and post-operative surgical (e.g.
intraabdominal collection, fistula, anastomotic leak) and medical (e.g.
pneumoniae, deep vein thrombosis) complications
|
30 days
|
|
Postoperative mortality
Tidsram: 30 days
|
I evaluate in-hospital and 30-day mortality correlate to the intervention
|
30 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Survival
Tidsram: 5 years
|
The length of time from the intervention that patients diagnosed with a T4 colon cancer are still alive.
|
5 years
|
|
Disease Free Survival
Tidsram: 5 years
|
The measure of time after treatment during which no sign of recurrence (local or metastatic) is found.
|
5 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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- Kapoor S, Das B, Pal S, Sahni P, Chattopadhyay TK. En bloc resection of right-sided colonic adenocarcinoma with adjacent organ invasion. Int J Colorectal Dis. 2006 Apr;21(3):265-8. doi: 10.1007/s00384-005-0756-z. Epub 2005 Jun 7.
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 januari 2021
Primärt slutförande (Förväntat)
1 januari 2021
Avslutad studie (Förväntat)
30 juni 2021
Studieregistreringsdatum
Först inskickad
17 november 2020
Först inskickad som uppfyllde QC-kriterierna
23 november 2020
Första postat (Faktisk)
30 november 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 december 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 november 2020
Senast verifierad
1 november 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LACC Trial
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Data will retrospectively collected from a maintained database in each center, created by the.
A local study manager will be identified for each participating center.
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