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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03364478
• Other study ID #: ShanghaiMISC-RHC
• Status: Not yet recruiting
• Phase: N/A
• First received: December 1, 2017
• Last updated: December 13, 2017
• Start date: January 1, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: November 2017
• Source: Shanghai Minimally Invasive Surgery Center
• Contact: Minhua Zheng, PhD
• Phone: +86-13564119545
• Email: zmhtiger[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 326
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Overall Survival
• Postoperative Complications

Intervention

Procedure:
• DML group
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.

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospttal	Shanghai	Sahgnhai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Minimally Invasive Surgery Center

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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: 10.10 — View 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; — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		3 years
Secondary	The rate of postoperative complication		30 days
Secondary	3 years overall survival		3 years
Secondary	The rate of local and distant recurrence		3 years