- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01724775
Efficacy and Safety Study of Complete Mesocolic Excision for Colon Cancer (ESCME)
A Prospective, Non-randomized, Double-blind, Single-center Study to Evaluate Efficacy and Safety of Complete Mesocolic Excision for Colon Cancer.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Materials and Methods:
All the patients with colon cancer will undergo elective radical operation. The observations were recorded during the operation and on the postoperative specimens. Intra-operative photographs were taken at various stages, as were photographs of the postoperative specimen. According to the CME operation keypoints, all the photographs will accept third-party assessment of the expert group, while the third-party expert group will not participate in the management of patients. Both of The evaluators and research doctors are double-blind state. The postoperative patients will divided into two groups according to the results of the assessment. The clinical and pathological data of the patients as well as follow-up information will be recorded and collected.
- Outcome of CME By comparison to clinicopathologic variables, and precise tissues morphometry of two groups, the prognosis, lymph nodes harvest and removal of the mesocolic area were investigated. Outcomes of interest also include disease-free survival, local recurrence-free survival, recurrence rate. In addition, we analyzed the correlation between mesocolic area and height, weight, body surface area and body mass index.
- Safety of CME CME group and non-CME group were compared the differences of security, included operation time, blood loss, postoperation complications, flatus restoring time, defecation restoring time, drainage removal time, Diet restoring time, drainage volume in three days after surgery, hospital deaths, the exhaust time, hospitalization time and hospitalization costs. In addition, the feasibility of CME techniques as the surgical approach of choice for elderly patients was also evaluated.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100044
- Rekruttering
- Department of Gastroenterology Surgery, Peking University People's Hospital
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Ta kontakt med:
- Zhidong Gao, M.D.
- Telefonnummer: 8610-88326600
- E-post: xiaoya-008@163.com
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Hovedetterforsker:
- Yingjiang Ye, M.D. & Ph.D.
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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:
- Clinical diagnosis of colon cancer;
- Clinical stage Ⅰ ~ Ⅲ;
- Undergoing colorectal surgery for the first time;
- Accept laparotomy;
- Accept radical resection;
- More than 18 years.
Exclusion Criteria:
- Emergency surgery;
- Preoperative neoadjuvant chemoradiotherapy history;
- Combined with other malignant diseases;
- Pathological stage Ⅳ patients with colon cancer.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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CME surgery for colon cancer
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non-CME surgery for colon cancer
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Prognosis assessment of postoperative patients
Tidsramme: yearly, up to 5 years
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The assessment of 5-year and 3-year overall survival, disease-free survival, local recurrence rate, local recurrence-free survival for postoperative patients respectively.
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yearly, up to 5 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Safety assessment of the patients in perioperation period
Tidsramme: Daily, up to one month
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Includes: postoperative complications, hospital mortality, operative time, blood loss, exhaust time, defecation time, drainage and unplug time, resumed eating time, drainage volume during postoperation three days and so on.
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Daily, up to one month
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Yingjiang Ye, M.D. & Ph.D., Peking University People's Hospital
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Wang C, Gao Z, Shen Z, Jiang K, Zhou J, Wang S, Ye Y. Five-Year Prognosis of Complete Mesocolic Excision in Patients with Colon Cancer: A Prospective, Nonrandomized, Double-Blind Controlled Trial. J Am Coll Surg. 2022 Oct 1;235(4):666-676. doi: 10.1097/XCS.0000000000000282. Epub 2022 Sep 15.
- Gao Z, Wang C, Cui Y, Shen Z, Jiang K, Shen D, Wang Y, Zhan S, Guo P, Yang X, Liu F, Shen K, Liang B, Yin M, Xie Q, Wang Y, Wang S, Ye Y. Efficacy and Safety of Complete Mesocolic Excision in Patients With Colon Cancer: Three-year Results From a Prospective, Nonrandomized, Double-blind, Controlled Trial. Ann Surg. 2020 Mar;271(3):519-526. doi: 10.1097/SLA.0000000000003012.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PKPH-CME
- Z121100005312015 (Annet stipend/finansieringsnummer: Science and Technology Project of Bejing, China)
- TG-2015-002 (Annet stipend/finansieringsnummer: Capital health development research project)
- 20130001120064 (Annet stipend/finansieringsnummer: Doctoral Program of Higher Education)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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