Abstract
BackgroundAlthough conventional laparoscopic and hand-assisted laparoscopic surgery for colorectal cancer is widely used today, there remain many technical challenges especially for right colon cancer in obese patients. Herein, we develop a novel hand-assisted laparoscopic surgery (HALS) with complete mesocolic excision (CME), D3 lymphadenectomy, and a total “no-touch” isolation technique (HALS-CME) in right hemicolectomy to overcome these issues. According to previous clinic practice, this novel procedure is not only feasible and safe but has several technical merits. However, the feasibility, short-term minimally invasive virtues, long-term oncological superiority, and potential total “no-touch” isolation technique benefits of HALS-CME should be confirmed by a prospective randomized controlled trial.Methods/designThis is a single-center, open-label, noninferiority, randomized controlled trial. Eligible participants will be randomly assigned to the HALS-CME group or to the laparoscopic surgery with CME, D3 lymphadenectomy, and total “no-touch” isolation technique (LAP-CME) group, or to conventional laparoscopic surgery with CME and D3 lymphadenectomy (cLAP) group at a 1:1:1 ratio using a centralized randomization list. Primary endpoints include safety, efficacy, and being oncologically clear, and 3-year disease-free, progression-free, and overall survival. Second endpoints include operative outcomes (operation time, blood loss, and incision length), pathologic evaluation (grading the plane of surgery, length of proximal and distal resection margins, distance between the tumor and the central arterial high tie, distance between the nearest bowel wall and the same high tie, area of mesentery resected, width of the chain of lymph-adipose tissue, length of the central lymph-adipose chain, number of harvested lymph nodes), and postoperative outcomes (pain intensity, postoperative inflammatory and immune responses, postoperative recovery).DiscussionThis trial will provide valuable clinical evidence for the feasibility, safety, and potential total “no-touch” isolation technique benefits of HALS-CME for right hemicolectomy. The hypothesis is that HALS-CME is feasible for the radical D3 resection of right colon cancer and offers short-term safety and long-term oncological superiority compared with conventional laparoscopic surgery.Trial registrationClinicalTrials.gov, NCT02625272. Registered on 8 December 2015.
Highlights
Conventional laparoscopic and hand-assisted laparoscopic surgery for colorectal cancer is widely used today, there remain many technical challenges especially for right colon cancer in obese patients
The hypothesis is that hand-assisted laparoscopic surgery (HALS)-complete mesocolic excision (CME) is feasible for the radical D3 resection of right colon cancer and offers short-term safety and long-term oncological superiority compared with conventional laparoscopic surgery
Progress in the treatment of colon cancer mainly includes that: 1) both European complete mesocolic excision (CME) with central vascular ligation (CVL) and Japanese D3 lymphadenectomy were demonstrated to have oncological superiority compared with traditional surgery [6,7,8]; 2) the feasibility and safety of laparoscopic right hemicolectomy with CME or D3 lymphadenectomy for right colon cancer has been confirmed [9,10,11]
Summary
Since total mesorectal excision (TME) has been accepted worldwide, the survival from rectal cancer has significantly improved, and is even better than for colon cancer in some countries [14,15,16,17]. In 1952, Barnes first described and adopted a special technique for resection of right colon cancer: ligation of the vascular pedicles and division of the bowel before handling the cancer-bearing segment [24] This special technique was first named a “no-touch” isolation technique by Turnbull in 1953, based on previous clinical and basic research [25]. If the feasibility, short-term safety, long-term oncological safety, and potential total “no-touch” isolation technique benefits of HALS-CME are verified, this technique could be recommended as a new approach to overcome the technical challenges in right hemicolectomy for right colon cancer. Trial status This trial was initiated in December 2015 and is currently recruiting patients.
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