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

NCT ID: NCT03364478

Last Updated: 2017-12-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Overall Survival Postoperative Complications

Keywords

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Surgical approach Laparoscopic right hemicolectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DML group

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.

Group Type EXPERIMENTAL

DML group

Intervention Type PROCEDURE

The group underwent laparoscopic right hemicolectomy with dorsal and medial hybrid approach.

MLA group

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.

Group Type ACTIVE_COMPARATOR

MLA group

Intervention Type PROCEDURE

The group underwent laparoscopic right hemicolectomy with traditional medial-to-lateral approach.

Interventions

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DML group

The group underwent laparoscopic right hemicolectomy with dorsal and medial hybrid approach.

Intervention Type PROCEDURE

MLA group

The group underwent laparoscopic right hemicolectomy with traditional medial-to-lateral approach.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Minimally Invasive Surgery Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minhua Zheng, PhD

Role: STUDY_DIRECTOR

Ruijin Hospital

Locations

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Shanghai Ruijin Hospttal

Shanghai, Sahgnhai, China

Site Status

Countries

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China

Central Contacts

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Minhua Zheng, PhD

Role: CONTACT

Phone: +86-13564119545

Email: [email protected]

Hiju Hong, PhD Student

Role: CONTACT

Phone: +86-13564119545

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 11213054 (View on PubMed)

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.

Reference Type RESULT
PMID: 25135445 (View on PubMed)

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.

Reference Type RESULT
PMID: 27318491 (View on PubMed)

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.

Reference Type RESULT
PMID: 27072997 (View on PubMed)

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.

Reference Type RESULT
PMID: 26917918 (View on PubMed)

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.

Reference Type RESULT
PMID: 26303693 (View on PubMed)

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.

Reference Type RESULT
PMID: 26801787 (View on PubMed)

Other Identifiers

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ShanghaiMISC-RHC

Identifier Type: -

Identifier Source: org_study_id