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

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).

Figures

Fig. 1

Time schedule and flow of participants

Fig. 2

Operative position and single-incision multichannel device. a The patient is placed in a lithotomy position. The surgeon stands at the patient’s right side with the first assistant at the left side, while the camera operator stands beside the patient’s right shoulder with the monitor placed beside the patient’s left leg. b The homemade multichannel device comprises a soft tissue retractor and a surgical glove

Fig. 3

Trocar positions and surgical procedure for the experimental intervention group. a, b Trocars and instrument positions for single incision plus one port laparoscopic surgery (SILS plus one). c Ligation of the inferior mesenteric artery and vein. d The distal rectum is dissected by inserting a linear stapling device through the surgeon’s dominant operation channel

Fig. 4

Trocar positions and surgical procedure for the control intervention group. a, b Trocars and instrument positions for conventional laparoscopic surgery (CLS). c Ligation of the inferior mesenteric artery and vein. d The distal rectum is dissected by inserting a linear stapling device through the surgeon’s dominant operation channel

Fig. 5

Specimen measurement. a Macroscopic quality of the complete mesocolic excision. b Length of the proximal and distal dissection margins. c Tumor diameter