Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01724775
Other study ID # PKPH-CME
Secondary ID Z121100005312015
Status Recruiting
Phase N/A
First received November 4, 2012
Last updated August 17, 2016
Start date November 2012
Est. completion date December 2017

Study information

Verified date August 2016
Source Peking University People's Hospital
Contact Zhidong Gao, M.D.
Phone 15810195892
Email xiaoya-008@163.com
Is FDA regulated No
Health authority China: Beijing Municipal Science and Technology CommissionChina: Ethics Committee
Study type Observational

Clinical Trial Summary

In 2009, Prof. Hohenberger proposed complete mesocolic excision (CME) as standardized, in which the same principle of TME in rectal cancer has been applied to the colon. More and more surgeons pay attention to the rationality of this surgical approach. However, the clinical application researches are still few, in particular the prospective controlled study is still none. This clinical trial will compare the CME group and non-CME group to evaluate the outcome and safety of CME for apply in clinic.


Description:

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.

1. 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.

2. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 450
Est. completion date December 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of colon cancer;

- Clinical stage ? ~ ?;

- 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 ? patients with colon cancer.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Department of Gastroenterology Surgery, Peking University People's Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Shan Wang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prognosis assessment of postoperative patients The assessment of 5-year and 3-year overall survival, disease-free survival, local recurrence rate, local recurrence-free survival for postoperative patients respectively. yearly, up to 5 years No
Secondary Safety assessment of the patients in perioperation period 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. Daily, up to one month No
See also
  Status Clinical Trial Phase
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT03213314 - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies N/A
Enrolling by invitation NCT05534490 - Surgery and Functionality in Older Adults N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Terminated NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Recruiting NCT06397287 - PROM Project Urology
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03432429 - Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Recruiting NCT05370404 - Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain: N/A
Not yet recruiting NCT05467319 - Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS Phase 3
Recruiting NCT04602429 - Children's Acute Surgical Abdomen Programme
Completed NCT03124901 - Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor N/A
Completed NCT04595695 - The Effect of Clear Masks in Improving Patient Relationships N/A
Recruiting NCT06103136 - Maestro 1.0 Post-Market Registry
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT04059328 - Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
Recruiting NCT03697278 - Monitoring Postoperative Patient-controlled Analgesia (PCA) N/A