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

N

Naval Military Medical University

Status

Not yet enrolling

Conditions

Colorectal Cancer

Treatments

Procedure: Laparoscopic colorectal cancer resection
Procedure: Colorectal cancer resection via minilaparotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03843398
SINOCOLO2019C

Details and patient eligibility

About

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

Enrollment

992 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

992 participants in 2 patient groups

Minilaparotomy Group
Experimental group
Description:
Participants in this arm undergo colorectal cancer resection via minilaparotomy.
Treatment:
Procedure: Colorectal cancer resection via minilaparotomy
Laparoscopy Group
Active Comparator group
Description:
Participants in this arm undergo laparoscopic colorectal cancer resection.
Treatment:
Procedure: Laparoscopic colorectal cancer resection

Trial contacts and locations

0

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Central trial contact

Zi-Ye ZHAO, MD

Data sourced from clinicaltrials.gov

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