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Comparative Study of Medial-to-Lateral Approach vs Dorsal and Medial Hybrid Approach in Laparoscopic Right Hemicolectomy

Primary Purpose

Overall Survival, Postoperative Complications

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DML group
MLA group
Sponsored by
Shanghai Minimally Invasive Surgery Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overall Survival focused on measuring Surgical approach, Laparoscopic right hemicolectomy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged more then 18 years old;
  • Diagnosed as right hemi colonic cancer with colonoscopic biopsy;
  • Without metastasis;
  • No Invasion of surrounding tissues;
  • Limited operation;
  • Underwent laparoscopic radical right hemicolectomy (L-right hemicolectomy);
  • BMI 18~30kg/m2;
  • Without multiple primary tumors;
  • Sign on the Medical informed Consent.

Exclusion Criteria:

  • Simultaneous or simultaneous multiple primary colorectal cancer;

  • Preoperative imaging examination results show:

    1. Tumor involves the surrounding organs and combined organ resection need to be done;
    2. Distant metastasis;
    3. Unable to perform R0 resection;
  • History of any other malignant tumor in recent 5 years;
  • Patients need emergency operation;
  • Not suitable for laparoscopic surgery;
  • Women during Pregnancy or breast feeding period;
  • Informed consent refusal

Sites / Locations

  • Shanghai Ruijin Hospttal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DML group

MLA group

Arm Description

The group underwent laparoscopic right hemicolectomy with dorsal and medial hybrid approach. In DML group, the dissecting based on CME is performed with dorsal approach and medial approach hybridized.

The group underwent laparoscopic right hemicolectomy with traditional medial-to-lateral approach. In MLA group,the dissecting based on CME is performed with meidial-to-lateral approach.

Outcomes

Primary Outcome Measures

Disease-free survival

Secondary Outcome Measures

The rate of postoperative complication
3 years overall survival
The rate of local and distant recurrence

Full Information

First Posted
December 1, 2017
Last Updated
December 13, 2017
Sponsor
Shanghai Minimally Invasive Surgery Center
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1. Study Identification

Unique Protocol Identification Number
NCT03364478
Brief Title
Comparative Study of Medial-to-Lateral Approach vs Dorsal and Medial Hybrid Approach in Laparoscopic Right Hemicolectomy
Official Title
Randomized Controlled Trial: Comparative Study of Medial-to-Lateral Approach vs Dorsal and Medial Hybrid Approach in Laparoscopic Right Hemicolectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Minimally Invasive Surgery Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether dorsal and medial hybrid approach could improve disease-free survival in patients with right colon cancer, compared with traditional medial-to-lateral approach in laparoscopic righ hemicolectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overall Survival, Postoperative Complications
Keywords
Surgical approach, Laparoscopic right hemicolectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
326 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DML group
Arm Type
Experimental
Arm Description
The group underwent laparoscopic right hemicolectomy with dorsal and medial hybrid approach. In DML group, the dissecting based on CME is performed with dorsal approach and medial approach hybridized.
Arm Title
MLA group
Arm Type
Active Comparator
Arm Description
The group underwent laparoscopic right hemicolectomy with traditional medial-to-lateral approach. In MLA group,the dissecting based on CME is performed with meidial-to-lateral approach.
Intervention Type
Procedure
Intervention Name(s)
DML group
Intervention Description
The group underwent laparoscopic right hemicolectomy with dorsal and medial hybrid approach.
Intervention Type
Procedure
Intervention Name(s)
MLA group
Intervention Description
The group underwent laparoscopic right hemicolectomy with traditional medial-to-lateral approach.
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
The rate of postoperative complication
Time Frame
30 days
Title
3 years overall survival
Time Frame
3 years
Title
The rate of local and distant recurrence
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged more then 18 years old; Diagnosed as right hemi colonic cancer with colonoscopic biopsy; Without metastasis; No Invasion of surrounding tissues; Limited operation; Underwent laparoscopic radical right hemicolectomy (L-right hemicolectomy); BMI 18~30kg/m2; Without multiple primary tumors; Sign on the Medical informed Consent. Exclusion Criteria: Simultaneous or simultaneous multiple primary colorectal cancer; Preoperative imaging examination results show: Tumor involves the surrounding organs and combined organ resection need to be done; Distant metastasis; Unable to perform R0 resection; History of any other malignant tumor in recent 5 years; Patients need emergency operation; Not suitable for laparoscopic surgery; Women during Pregnancy or breast feeding period; Informed consent refusal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minhua Zheng, PhD
Phone
+86-13564119545
Email
zmhtiger@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
Hiju Hong, PhD Student
Phone
+86-13564119545
Email
jing12722@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minhua Zheng, PhD
Organizational Affiliation
Ruijin Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Ruijin Hospttal
City
Shanghai
State/Province
Sahgnhai
ZIP/Postal Code
200000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11213054
Citation
Fujita J, Uyama I, Sugioka A, Komori Y, Matsui H, Hasumi A. Laparoscopic right hemicolectomy with radical lymph node dissection using the no-touch isolation technique for advanced colon cancer. Surg Today. 2001;31(1):93-6. doi: 10.1007/s005950170230.
Results Reference
result
PubMed Identifier
25135445
Citation
Matsuda T, Iwasaki T, Mitsutsuji M, Hirata K, Maekawa Y, Tanaka T, Shimada E, Kakeji Y. Cranial-to-caudal approach for radical lymph node dissection along the surgical trunk in laparoscopic right hemicolectomy. Surg Endosc. 2015 Apr;29(4):1001. doi: 10.1007/s00464-014-3761-x. Epub 2014 Aug 19.
Results Reference
result
PubMed Identifier
27318491
Citation
Li H, He Y, Lin Z, Xiong W, Diao D, Wang W, Wan J, Zou L. Laparoscopic caudal-to-cranial approach for radical lymph node dissection in right hemicolectomy. Langenbecks Arch Surg. 2016 Aug;401(5):741-6. doi: 10.1007/s00423-016-1465-5. Epub 2016 Jun 18.
Results Reference
result
PubMed Identifier
27072997
Citation
Zou L, Xiong W, Mo D, He Y, Li H, Tan P, Wang W, Wan J. Laparoscopic Radical Extended Right Hemicolectomy Using a Caudal-to-Cranial Approach. Ann Surg Oncol. 2016 Aug;23(8):2562-3. doi: 10.1245/s10434-016-5215-2. Epub 2016 Apr 12.
Results Reference
result
PubMed Identifier
26917918
Citation
Lotti M, Capponi MG, Campanati L, Bertoli P, Palamara F, Coccolini F, Ansaloni L. Laparoscopic right colectomy: Miles away or just around the corner? J Minim Access Surg. 2016 Jan-Mar;12(1):41-6. doi: 10.4103/0972-9941.158960.
Results Reference
result
PubMed Identifier
26303693
Citation
Zheng B, Wang N, Wu T, Qiao Q, Zhou S, Zhang B, Yang Y, Xie S, Wang K, He X. [Comparison of cranial-to-caudal medial versus traditional medial approach in laparoscopic right hemicolectomy: a case-control study]. Zhonghua Wei Chang Wai Ke Za Zhi. 2015 Aug;18(8):812-6. Chinese.
Results Reference
result
PubMed Identifier
26801787
Citation
Honaker M, Scouten S, Sacksner J, Ziegler M, Wasvary H. A medial to lateral approach offers a superior lymph node harvest for laparoscopic right colectomy. Int J Colorectal Dis. 2016 Mar;31(3):631-4. doi: 10.1007/s00384-015-2499-9. Epub 2016 Jan 22.
Results Reference
result

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Comparative Study of Medial-to-Lateral Approach vs Dorsal and Medial Hybrid Approach in Laparoscopic Right Hemicolectomy

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