- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01772407
Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery? (CHIRCOL)
Right Colon Cancer: Laparoscopic Surgery Versus Open Surgery, Costs, Mortality, Morbidity and Quality of Life
Studieoversikt
Status
Forhold
Detaljert beskrivelse
The aim of the present study is to compare in the long-term costs of laparoscopic and open right cancer colectomy as well as the mortality the morbidity and the quality of life of the operated patients.
The number of patients need to get a 54% power is 300. The average number of patients/surgical center is approximately 27 in 14 surgical centers.
The proposed undertaking of every patient is fully identical to that which is usually proposed by the surgical center in charge of the patient (i.d. 7 centers will perform laparoscopic procedures and 7 centers open procedure according to their usual practice).
A complete information leaflet will be given to the patients during the first consultation which will correspond to the enrollment day.
The preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.
The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.
The follow-up encompass 5 postoperative consultations:1 month, 6 ,12 ,18 and 24 months.
On every consultation the patient will fill a very simple validated quality of life questionnaire (EORTC,QLQ.C30) an give back a weekly journal reporting the potentially arising medical and surgical events.
Globally the comparative analysis of the costs ,the mortality ,the morbidity, the quality of life ot the patients undergoing either a laparoscopic or a open right colectomy for cancer will be performed controling for the carcinologic equivalence of the two surgical strategies.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Paris, Frankrike, 75013
- Pitié-Salpêtrière Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Age ≥18 years old <= 80 years old
- Right colon cancer < T4 without metastasis
- <T4 N0M0
Exclusion Criteria:
- Pregnant patient
- T4 cancer
- Metastasis
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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1
laparoscopic surgery in right colon cancer operations
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2
open surgery in right colon cancer operations
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Cost during the 2 postoperative years
Tidsramme: during the 2 postoperative years
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during the 2 postoperative years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Mortality, morbidity and quality of life during the 2 postoperative years
Tidsramme: during the 2 postoperative years
|
during the 2 postoperative years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Laurent Hannoun, MD, PhD, Assistance Publique - Hôpitaux de Paris
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STIC ICO711
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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