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Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer (SoMiniCRC)

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ClinicalTrials.gov Identifier: NCT03843398
Recruitment Status : Not yet recruiting
First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
En-Da Yu, Changhai Hospital

Brief Summary:

The primary aim of this study is

- to determine the difference of survival outcome (3-year overall survival, 3y OS) between after minilaparotomy and after laparoscopy..

Other aims include to determine the data below when minilaparotomy and laparoscopy are compared with each other.

  • 3-year disease free survival, 3y DFS
  • 5-year overall survival, 5y OS
  • 5-year disease free survival, 5y DFS
  • Local recurrence rate, LRR
  • Postoperative complications Incidence and mortality at 30 days

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Colorectal cancer resection via minilaparotomy Procedure: Laparoscopic colorectal cancer resection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 992 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : April 1, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Minilaparotomy Group
Participants in this arm undergo colorectal cancer resection via minilaparotomy.
Procedure: Colorectal cancer resection via minilaparotomy
According to the cancer location, a 7 cm incision is made in specific area of the patient's abdomen. The whole procedure of operation will be finished within this incision. If the incision must be lengthen due to the surgical demand, the failure of the minilaparotomy is determined.
Other Name: Minilaparotomy

Active Comparator: Laparoscopy Group
Participants in this arm undergo laparoscopic colorectal cancer resection.
Procedure: Laparoscopic colorectal cancer resection
This is one of the routine procedures used for colorectal cancer resection.
Other Name: Laparoscopy




Primary Outcome Measures :
  1. 3-year overall survival, 3y OS [ Time Frame: 3 years after the follow up of the last patient enrolled. ]
    3y OS


Secondary Outcome Measures :
  1. 5-year overall survival, 5y OS [ Time Frame: 5 years after the follow up of the last patient enrolled. ]
    5y OS

  2. 3-year disease free survival, 3y DFS [ Time Frame: 3 years after the follow up of the last patient enrolled. ]
    3y DFS

  3. 5-year disease free survival, 3y DFS [ Time Frame: 5 years after the follow up of the last patient enrolled. ]
    5y DFS

  4. Local recurrence rate, LRR [ Time Frame: 3 years after the follow up of the last patient enrolled. ]
    LRR

  5. Postoperative complications Incidence at 30 days [ Time Frame: 30 days after the operation of the last patient enrolled. ]
    PCI30

  6. Postoperative mortality at 30 days [ Time Frame: 30 days after the operation of the last patient enrolled. ]
    PM30



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Colorectal cancer with pathological results.
  • Colorectal cancer preliminary diagnosed during colonoscopy.
  • No confirmed metastasis.
  • No comorbidity of other malignancy.
  • The primary tumor is less than 10 cm.
  • No organ dysfunction.
  • The patient and his families totally agree with the whole investigative procedure, and sign the written informed consent form.

Exclusion Criteria:

  • Diagnosed with any other malignancy within 5 years.
  • Comorbidity of emergent conditions like perforation.
  • Former colorectal surgery history which may affects digestive tract reconstruction.
  • Need combined organ resection.
  • ASA grade IV or V.
  • Pregnant or lactating Women.
  • Severe mental diseases.
  • Severe cardiopulmonary diseases which reduce operation tolerance.
  • Systematic steroid therapy lasting for more than 1 month.
  • Intolerant of laparoscopy.
  • No written informed consent form signed.

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): NCT03843398


Contacts
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Contact: Zi-Ye ZHAO, MD 8618699629177 yemenzhao@126.com

Sponsors and Collaborators
Changhai Hospital
Investigators
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Principal Investigator: En-Da YU, MBBS Changhai Hospital

Additional Information:
Publications:
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Responsible Party: En-Da Yu, Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03843398     History of Changes
Other Study ID Numbers: SINOCOLO2019C
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by En-Da Yu, Changhai Hospital:
Colorectal Cancer
Minilaparotomy
Survival
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases