Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer
NCT ID: NCT03843398
Last Updated: 2019-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
992 participants
INTERVENTIONAL
2019-04-01
2026-04-01
Brief Summary
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\- 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Minilaparotomy Group
Participants in this arm undergo colorectal cancer resection via minilaparotomy.
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.
Laparoscopy Group
Participants in this arm undergo laparoscopic colorectal cancer resection.
Laparoscopic colorectal cancer resection
This is one of the routine procedures used for colorectal cancer resection.
Interventions
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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.
Laparoscopic colorectal cancer resection
This is one of the routine procedures used for colorectal cancer resection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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En-Da Yu
Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy
Principal Investigators
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En-Da YU, MBBS
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Central Contacts
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References
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Wang XD, Huang MJ, Yang CH, Li K, Li L. Minilaparotomy to rectal cancer has higher overall survival rate and earlier short-term recovery. World J Gastroenterol. 2012 Oct 7;18(37):5289-94. doi: 10.3748/wjg.v18.i37.5289.
Ishida H, Ishiguro T, Ohsawa T, Okada N, Kumamoto K, Ishibashi K, Haga N, Yokoyama M, Nakada H, Gonda T. Oncologic outcome of stages II/III colon cancer treated via minilaparotomy. Int Surg. 2011 Apr-Jun;96(2):127-34. doi: 10.9738/1384.1.
Related Links
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PubMed link
PubMed link
Other Identifiers
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SINOCOLO2019C
Identifier Type: -
Identifier Source: org_study_id
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