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Laparoscopic Versus Open Right Hemicolectomy Within ERAS in Right-sided Colon Cancer

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ClinicalTrials.gov Identifier: NCT02944188
Recruitment Status : Recruiting
First Posted : October 25, 2016
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Xu jianmin, Fudan University

Brief Summary:
In this study, the investigators have compared the clinical outcomes of the laparoscopic and open right hemicolectomy within enhanced recovery after surgery (ERAS) programs in the treatment of right-sided colon cancer.

Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: Laparoscopic right hemicolectomy plus ERAS Procedure: Open right hemicolectomy plus ERAS Not Applicable

Detailed Description:

This study was a prospective, single-center, randomized control trial. Including criteria were (1) Age between 18 and 75 years; (2) Histologically confirmed right-sided colon adenocarcinoma;(3) Clinical stage I-III; (4) Performance status (ECOG) 0-1; (5) Adequate hematological, hepatic and renal function. Patients operated on as an emergency, or with tumours in the transverse colon, or with other previous malignancy within 5 years were excluded.

All particapants were recruited and randomly assigned to receive 3D-laproscopic or open right hemicoloectomy. All patients were treated with an ERAS protocol. The primary end-point was the incidence of postoperative complications within 30 days. Complications were diagnosed and classified according to the Clavien-Dindo classification. The secondary end-points were ERAS adherence, readmissions, reoperations, hospital length of stay, mortality, and survivals. The study was approved by the Ethics Committee of Zhongshan Hospital, Fudan University, Shanghai, China. Written informed consent was obtained for patients to participate the study. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 602 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 3D-Laparoscopic Versus Open Right Hemicolectomy in Treatment of Right-sided Colon Cancer Within an Enhanced Recovery After Surgery (ERAS) Protocol
Study Start Date : December 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: LRH plus ERAS
patients undergo Laparoscopic right hemicolectomy plus ERAS
Procedure: Laparoscopic right hemicolectomy plus ERAS
patients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs
Other Name: LRH ERAS

Active Comparator: ORH plus ERAS
patients undergo open right hemicolectomy plus ERAS
Procedure: Open right hemicolectomy plus ERAS
patients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs




Primary Outcome Measures :
  1. incidence of postoperative complications [ Time Frame: 30 days from surgery ]
    The incidence of postoperative complications within 30 days according to the Clavien-Dindo classification


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 3 years ]
    Time from randomization to deaths resulting from any reason

  2. disease-free survival [ Time Frame: 3 years ]
    Time from randomization to recurrence at any site or deaths resulting from any reason

  3. operative mortality [ Time Frame: 30 days post operatively ]
    Deaths related to surgery within 30 days from surgery


Other Outcome Measures:
  1. operative time [ Time Frame: Day 1 ]
    Time from start of incision to finish of abdomial closure

  2. estimated blood loss [ Time Frame: Day 1 ]
    Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.

  3. number of retrieved lymph nodes [ Time Frame: 1 week post operatively ]
    Numbers according to the pathological report

  4. postoperative hospital stay [ Time Frame: 30 days post operatively ]
    The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 75 years;
  2. Primary tumor has undergone histologically confirmed right-sided colon adenocarcinoma;
  3. Together with clinical or radiological evidence of Stage(T1-2,N0, M0) Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2007 revision of the International Union Against Cancer TNM staging system)
  4. Performance status (ECOG) 0~1
  5. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
  6. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
  7. Written informed consent for participation in the trial.

Exclusion Criteria:

  1. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
  2. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
  3. Known drug abuse/ alcohol abuse
  4. Legal incapacity or limited legal capacity
  5. Pre-existing peripheral neuropathy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944188


Contacts
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Contact: Jianmin Xu, MD 86-18917982975 xujmin@aliyun.com

Locations
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China
Zhongshan Hospital, Fudan University Recruiting
Shanghai, China, 200032
Contact: Pingping Xu, MD    86-21-18917982975      
Principal Investigator: jianmin xu, MD         
Sponsors and Collaborators
Xu jianmin
Investigators
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Study Director: Hong Jiang, MD Fudan University

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Responsible Party: Xu jianmin, Deputy director of the colorectal cancer center, Fudan University
ClinicalTrials.gov Identifier: NCT02944188     History of Changes
Other Study ID Numbers: ERAS-02
82345432 ( Other Grant/Funding Number: Shanghai key research projects )
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019

Keywords provided by Xu jianmin, Fudan University:
enhanced recovery after surgery
right hemicolectomy

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases