NCT03329495

Laparoscopic Right Hemicoloectomy for Right Colon Cancer With a Medial-to-lateral Approach Orientated by SMA or SMV

A Randomized Controlled Clinical Trial to Investigate the Effect of SMA- or SMV- Orientated Laparoscopic Right Hemicoloectomy for Right Colon Cancer With a Medial-to-lateral Approach

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled clinical trial to compare the outcomes of SMA- and SMV- orientated laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach

Detailed description

In 2008, Germany scholar W. Hohenberger proposed the idea of complete mesocolic excision (CME) and central vascular ligation (CVL) for the standardization of colonic cancer surgery. This concept has been widely recognized and accepted. This radical operation attempts to remove the mesocolon intactly by careful dissection along the embryologic tissue planes and transection of the supplying vessels at their origin. For right-sided colon cancer, this approach involves division of the vessels at their origin from the superior mesenteric artery (SMA) and superior mesenteric vein (SMV). In our opinion, full exposure of the SMA and SMV is necessary to make sure that the origin of the colonic arteries being truly exposed and tied centrally at their origin and a maximal harvest of the regional lymphnodes. For locally advanced colon cancer, SMA- orientated surgery may be more meaningful to recerve a radical lymphadenectomy and bring benefit for their survival. However, in the traditional practise, the lymph node dissection is orientated by SMV and SMA is not exposed, tissue around SMA is left behind. In this study, eligible patients with right colon cancer will be randomly allocated to receive either SMA- or SMV- orientated laparoscopic right hemicoloectomy. 100 patients will be enrolled in each group. In SMV- orientated surgery group, SMA is not exposed and the left boundary of resection is the left side of SMV. In SMA- orientated surgery group, the left boundary of resection is the left side of SMA and SMA is exposed.Artery sheath is not necessarily to be opened. Postoperative pathology will be analyzed with the number of lymph nodes retrieved. Postoperative recovery process and long term survival will be followed.

Conditions

• Right Colic Lymphadenopathy

Interventions

Type	Name	Description
PROCEDURE	SMA-orientated right hemicoloectomy	Laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach orientated by SMA. The left boundary of resection is the left side of SMA, and artery sheath is not necessarily being opened.
PROCEDURE	SMV-orientated right hemicoloectomy	Laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach orientated by SMV. The left boundary of resection is the left side of SMV, and SMA is not exposed.

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-01-01
• Completion: 2023-01-01
• First posted: 2017-11-06
• Last updated: 2017-11-06

Locations

1 site across 1 country: China