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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02117557
• Other study ID #: NFGS-SILS-01
• Status: Recruiting
• Phase: Phase 2
• First received: April 16, 2014
• Last updated: April 17, 2014
• Start date: April 2014
• Est. completion date: April 2022

Study information

• Verified date: April 2014
• Source: Nanfang Hospital of Southern Medical University
• Contact: Guoxin Li, M.D., PH.D.
• Phone: +86-138-0277-1450
• Email: gzliguoxin[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: April 2022
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 ?-?

• 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Single incision laparoscopic surgery

• Conventional laparoscopic surgery

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guoxin Li

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early morbidity rate	The early morbidity rate is defined as the event observed during operation and within 30 days after surgery,	30 days	Yes
Secondary	Operative outcomes	Operative time, estimated blood loss and incision length are recorded.	intraoperative	Yes
Secondary	Pathological outecomes	Tumor size, length of proximal and distal margin and lymph nodes harvested are used to assess oncological resection.	5 days	No
Secondary	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	No
Secondary	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	No
Secondary	Cosmetic assessment	Cosmetic assessment is perform using body image scale and cosmetic scale.	14 days	No
Secondary	3-year disease free survival rate		36 months	No
Secondary	5-year overall survival rate		60 months	No
Secondary	Inflammatory and immune response		7 days	No