Safety Study of Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

A Prospective Randomized Controlled Trial Comparing Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

• Compared with traditional open colectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its short- and long-term oncologic outcomes have been demonstrated.
• In experienced surgeons' hands, single incision laparoscopic surgery is increasingly performed for colorectal disease, and even for malignant lesion because of its reduced incision-associated morbidity and scarring.
• However, the safety and efficacy of single incision laparoscopic surgery for colorectal cancer has not yet been evaluated. Thus, the prospective randomized trial comparing single incision versus conventional laparoscopic surgery for colorectal cancer is needed.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Single incision laparoscopic surgery; Procedure: Conventional laparoscopic surgery

• Study Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510-515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Guoxin Li, M.D.,PH.D.; Phone Number: +86-138-0277-1450; Email: gzliguoxin@163.com
      • Sub-Investigator: Yanan Wang, M.D.
      • Sub-Investigator: Haijun Deng, M.D.,PH.D.
      • Sub-Investigator: Qi Xue, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years < age < 80 years
• Tumor located in rectosigmoid (defined as 10- to 30-cm from the anal verge)
• Pathological rectosigmoid carcinoma
• Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual
• Tumor size of 5 cm or less; 6) ECOG score is 0-1
• ASA socre is Ⅰ-Ⅲ
• Informed consent

Exclusion Criteria:

• Body mass index (BMI) >30 kg/m2
• Pregnant woman or lactating woman
• Severe mental disease
• Previous abdominal surgery
• Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
• Requirement of simultaneous surgery for other disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single incision laparoscopic surgery; Transumbilical single incision laparoscopic surgery will be performed for patients in this group.And addition of only one trocar through the stoma for drainage tube is allowed.	Procedure: Single incision laparoscopic surgery; Other Names: SILS
Active Comparator: Conventional laparoscopic surgery; Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.	Procedure: Conventional laparoscopic surgery; Other Names: CLS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early morbidity rate	The early morbidity rate is defined as the event observed during operation and within 30 days after surgery,	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year disease free survival rate		36 months
Pain score	Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day 1, 2, 3 and the day of discharge.	14 days
5-year overall survival rate		60 months
Operative outcomes	Operative time, estimated blood loss and incision length are recorded.	intraoperative
Pathological outecomes	Tumor size, length of proximal and distal margin and lymph nodes harvested are used to assess oncological resection.	5 days
Postoperative recovery course	Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recoverty course.	14 days
Cosmetic assessment	Cosmetic assessment is perform using body image scale and cosmetic scale.	14 days
Inflammatory and immune response		7 days

Collaborators and Investigators

• Sponsor: Guoxin Li

Publications and helpful links

General Publications

• Gash KJ, Goede AC, Chambers W, Greenslade GL, Dixon AR. Laparoendoscopic single-site surgery is feasible in complex colorectal resections and could enable day case colectomy. Surg Endosc. 2011 Mar;25(3):835-40. doi: 10.1007/s00464-010-1275-8. Epub 2010 Aug 24.
• Bucher P, Pugin F, Morel P. Single-port access laparoscopic radical left colectomy in humans. Dis Colon Rectum. 2009 Oct;52(10):1797-801. doi: 10.1007/DCR.0b013e3181b551ce.
• Lim SW, Kim HJ, Kim CH, Huh JW, Kim YJ, Kim HR. Umbilical incision laparoscopic colectomy with one additional port for colorectal cancer. Tech Coloproctol. 2013 Apr;17(2):193-9. doi: 10.1007/s10151-012-0900-z. Epub 2012 Sep 19.
• Hirano Y, Hattori M, Douden K, Shimizu S, Sato Y, Maeda K, Hashizume Y. Single-incision plus one port laparoscopic anterior resection for rectal cancer as a reduced port surgery. Scand J Surg. 2012;101(4):283-6. doi: 10.1177/145749691210100411.
• Wang Y, Deng H, Mou T, Li J, Liu H, Zhou H, Li G. Short-term outcomes of single-incision plus one-port laparoscopic versus conventional laparoscopic surgery for rectosigmoid cancer: a randomized controlled trial. Surg Endosc. 2019 Mar;33(3):840-848. doi: 10.1007/s00464-018-6350-6. Epub 2018 Jul 13.
• Wang Y, Liu R, Zhang Z, Xue Q, Yan J, Yu J, Liu H, Zhao L, Mou T, Deng H, Li G. A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial. Trials. 2015 Nov 30;16:539. doi: 10.1186/s13063-015-1067-5.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: April 16, 2014
• First Submitted That Met QC Criteria: April 17, 2014
• First Posted (Estimate): April 21, 2014

Study Record Updates

• Last Update Posted (Estimate): April 21, 2014
• Last Update Submitted That Met QC Criteria: April 17, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Laparoscopy; Single-incision
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NFGS-SILS-01