A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial.

Yanan Wang, Ruoyan Liu, Ze Zhang, Qi Xue, Jun Yan, Jiang Yu, Hao Liu, Liying Zhao, Tingyu Mou, Haijun Deng, Guoxin Li

Journal: Trials 2016;16():539

PMID: 26620555

Free Full Text on BioMed Central View on PubMed

Abstract

BACKGROUND

Single-incision laparoscopic surgery (SILS) is an emerging minimally invasive surgery to reduce abdominal incisions. However, despite the increasing clinical application of SILS, no evidence from large-scale, randomized controlled trials is available for assessing the feasibility, short-term safety, oncological safety, and potential benefits of SILS compared with conventional laparoscopic surgery (CLS) for colorectal cancer.

METHODS/DESIGN

This is a single-center, open-label, noninferiority, randomized controlled trial. A total of 198 eligible patients will be randomly assigned to transumbilical single incision plus one port laparoscopic surgery (SILS plus one) group or to a CLS group at a 1:1 ratio. Patients ranging in age from 18 to 80 years with rectosigmoid cancer diagnosed as cT1-4aN0-2 M0 and a tumor size no larger than 5 cm are considered eligible. The primary endpoint is early morbidity, as evaluated by an independent investigator. Secondary outcomes include operative outcomes (operative time, estimated blood loss, and incision length), pathologic outcomes (tumor size, length of proximal and distal resection margins, and number of harvested lymph nodes), postoperative inflammatory and immune responses (white blood cells [WBC], neutrophil percentage [NE %], C-reactive protein [CRP], interleukin-6 [IL-6], and tumor necrosis factor-α [TNF-α]), postoperative recovery (time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay), pain intensity, body image and cosmetic assessment, 3-year disease free survival (DFS), and 5-year overall survival (OS). Follow-up visits are scheduled for 1 and 3 months after surgery, then every 3 months for the first 2 years and every 6 months for the next 3 years.

DISCUSSION

This trial will provide valuable clinical evidence for the objective assessment of the feasibility, safety, and potential benefits of SILS plus one compared with CLS for the radical resection of rectosigmoid cancer. The hypothesis is that SILS plus one is feasible for the radical resection of rectosigmoid cancer and offers short-term safety and long-term oncological safety comparable to that of CLS, and that SILS plus one offers better cosmetic results and faster convalescence compared to CLS.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT02117557 (registered on 16 April 2014).

Address: Department of General Surgery, Nanfang Hospital, Southern Medical University, North Guangzhou Road 1838, 510-515, Guangzhou, China. [email protected].; Department of General Surgery, Nanfang Hospital, Southern Medical University, North Guangzhou Road 1838, 510-515, Guangzhou, China. [email protected].; Department of General Surgery, Nanfang Hospital, Southern Medical University, North Guangzhou Road 1838, 510-515, Guangzhou, China. [email protected].; Department of General Surgery, Nanfang Hospital, Southern Medical University, North Guangzhou Road 1838, 510-515, Guangzhou, China. [email protected].; Department of General Surgery, Nanfang Hospital, Southern Medical University, North Guangzhou Road 1838, 510-515, Guangzhou, China. [email protected].; Chinese Medical Doctor Association, Beijing, China. [email protected].; Chinese Anti-cancer Association, Tianjin, China. [email protected].; Department of General Surgery, Nanfang Hospital, Southern Medical University, North Guangzhou Road 1838, 510-515, Guangzhou, China. [email protected].; Chinese Medical Doctor Association, Beijing, China. [email protected].; Endoscopic and Laparoscopic Surgeons of Asia, Seoul, Korea. [email protected].; Department of General Surgery, Nanfang Hospital, Southern Medical University, North Guangzhou Road 1838, 510-515, Guangzhou, China. [email protected].; Department of General Surgery, Nanfang Hospital, Southern Medical University, North Guangzhou Road 1838, 510-515, Guangzhou, China. [email protected].; Department of General Surgery, Nanfang Hospital, Southern Medical University, North Guangzhou Road 1838, 510-515, Guangzhou, China. [email protected].; Department of General Surgery, Nanfang Hospital, Southern Medical University, North Guangzhou Road 1838, 510-515, Guangzhou, China. [email protected].; Chinese Anti-cancer Association, Tianjin, China. [email protected].; Department of General Surgery, Nanfang Hospital, Southern Medical University, North Guangzhou Road 1838, 510-515, Guangzhou, China. [email protected].; Chinese Medical Doctor Association, Beijing, China. [email protected].; Chinese Anti-cancer Association, Tianjin, China. [email protected].; Endoscopic and Laparoscopic Surgeons of Asia, Seoul, Korea. [email protected].; The Royal College of Surgeons of England, London, England. [email protected].; World Gastrointestinal and Endoscopic Doctors Association, Hongkong, China. [email protected].; International Association of Surgeons, Gastroenterologists and Oncologists, Kyoto, Japan. [email protected].; Society of American Gastrointestinal and Endoscopic Surgeons, Los Angeles, CA, USA. [email protected].; International Gastric Cancer Association, Tokyo, Japan. [email protected].; Harbin Medical University Cancer Hospital, Harbin, China. [email protected].; The Third Affiliated Hospital of Nanchang University, Nanchang, China. [email protected].; Jiaozhou Central Hospital of Qingdao, Qingdao, China. [email protected].; The Affiliated Tumor Hospital of Zhengzhou University, Zhengzhou, China. [email protected].

DOI: 10.1186/s13063-015-1067-5

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https://assays.cancer.gov/CPTAC-1478

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https://antibodies.cancer.gov/detail/CPTC-CRP-1

MeSH Terms: Adolescent, Adult, Aged, Aged, 80 and over, Blood Loss, Surgical, China, Clinical Protocols, Colectomy, Colorectal Neoplasms, Disease-Free Survival, Female, Humans, Laparoscopy, Length of Stay, Male, Middle Aged, Neoplasm Staging, Operative Time, Patient Satisfaction, Postoperative Complications, Research Design, Risk Factors, Time Factors, Treatment Outcome, Tumor Burden, Umbilicus, Young Adult