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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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Beijing
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Beijing, Beijing, China, 100044
- Werving
- Department of Gastroenterology Surgery, Peking University People's Hospital
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Contact:
- Zhidong Gao, M.D.
- Telefoonnummer: 8610-88326600
- E-mail: xiaoya-008@163.com
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Hoofdonderzoeker:
- Yingjiang Ye, M.D. & Ph.D.
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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CME surgery for colon cancer
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non-CME surgery for colon cancer
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Prognosis assessment of postoperative patients
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Safety assessment of the patients in perioperation period
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Yingjiang Ye, M.D. & Ph.D., Peking University People's Hospital
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PKPH-CME
- Z121100005312015 (Ander subsidie-/financieringsnummer: Science and Technology Project of Bejing, China)
- TG-2015-002 (Ander subsidie-/financieringsnummer: Capital health development research project)
- 20130001120064 (Ander subsidie-/financieringsnummer: Doctoral Program of Higher Education)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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