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

Overview

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.

Full Title of Study: “Randomized Controlled Trial: Comparative Study of Medial-to-Lateral Approach vs Dorsal and Medial Hybrid Approach in Laparoscopic Right Hemicolectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 1, 2021

Interventions

  • Procedure: DML group
    • The group underwent laparoscopic right hemicolectomy with dorsal and medial hybrid approach.
  • Procedure: MLA group
    • The group underwent laparoscopic right hemicolectomy with traditional medial-to-lateral approach.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Disease-free survival
    • Time Frame: 3 years

Secondary Measures

  • The rate of postoperative complication
    • Time Frame: 30 days
  • 3 years overall survival
    • Time Frame: 3 years
  • The rate of local and distant recurrence
    • Time Frame: 3 years

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 85 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Shanghai Minimally Invasive Surgery Center
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Minhua Zheng, PhD, Study Director, Ruijin Hospital
    • Overall Contact(s)
      • Minhua Zheng, PhD, +86-13564119545, zmhtiger@yeah.net

    Citations Reporting on Results

    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.

    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.

    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.

    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.

    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.

    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.

    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.

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