- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Beijing
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Beijing, Beijing, Chine, 100044
- Recrutement
- Department of Gastroenterology Surgery, Peking University People's Hospital
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Contact:
- Zhidong Gao, M.D.
- Numéro de téléphone: 8610-88326600
- E-mail: xiaoya-008@163.com
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Chercheur principal:
- Yingjiang Ye, M.D. & Ph.D.
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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CME surgery for colon cancer
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non-CME surgery for colon cancer
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Prognosis assessment of postoperative patients
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Safety assessment of the patients in perioperation period
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Yingjiang Ye, M.D. & Ph.D., Peking University People's Hospital
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PKPH-CME
- Z121100005312015 (Autre subvention/numéro de financement: Science and Technology Project of Bejing, China)
- TG-2015-002 (Autre subvention/numéro de financement: Capital health development research project)
- 20130001120064 (Autre subvention/numéro de financement: Doctoral Program of Higher Education)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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