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: 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
- 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
- Disease-free survival
- Time Frame: 3 years
- 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
- 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
- Lead Sponsor
- Shanghai Minimally Invasive Surgery Center
- Provider of Information About this Clinical Study
- Overall Official(s)
- Minhua Zheng, PhD, Study Director, Ruijin Hospital
- Overall Contact(s)
- Minhua Zheng, PhD, +86-13564119545, email@example.com
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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