Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Colorectal Cancer Clinical Trial

— mSILSC  

Official title:

Multi-center Prospective Randomized Controlled Study of the Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03633539
• Other study ID #: RJ-mSILSC-2018
• Status: Withdrawn
• Phase: N/A
• Start date: August 2020
• Est. completion date: December 2025

Study information

• Verified date: September 2021
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the short-term and long-term results after single incision laparoscopic surgery for colorectal cancer（SILSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）.

Description:

In order to improve cosmetic effect and reduce postoperative pain, single-incision laparoscopic surgery (SILS) is attracting increasing attention. SILS is considered to be the next major advance in the progress of minimally invasive surgical approaches to colorectal disease that is more feasible in generalized use. In most previous studies, SILS for colorectal cancer was feasible and short-term safe compared to conventional laparoscopic surgery (CLS) . However, there is still controversy over its potential better cosmetic effect and less postoperative pain. Moreover, the long-term oncologic outcomes are still inconclusive as only a few studies showed long-term survival data. Up to now, most studies were limited to their retrospective nature and small samples. So more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for SILS for colorectal cancer.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2025
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Inclusion Criteria:

• 18 years < age =85 years

• Tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection)

• Pathological colorectal carcinoma

• Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 8th Edition of AJCC Cancer Staging Manual

• Tumor size of 5 cm or less

• ECOG score is 0-1

• ASA score is ?-?

• Informed consent

Exclusion Criteria:

• Body mass index (BMI) >35 kg/m2

• The lower border of the tumor is located distal to the peritoneal reflection

• Pregnant woman or lactating woman

• Severe mental disease

• Previous abdominal surgery(except appendectomy and cholecystotomy)

• Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer

• Requirement of simultaneous surgery for other disease

Related Conditions & MeSH terms

• Colon Cancer
• Colon Disease
• Colonic Diseases
• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasms
• Rectal Cancer
• Rectal Diseases
• Rectal Neoplasms

Intervention

Procedure:
• Single-incision Laparoscopic Surgery
Patients undergo single-incision laparoscopic surgery. In this group,the surgery is performed through a transumbilical port. The surgeon will adjust surgical position to expose the operative field with the help of gravity. Besides,hand over hand cross and parallel techniques are needed to achieve the SILS. All the other operative procedures are the same as conventional laparoscopic surgery.
• Conventional Laparoscopic Surgery
Patients undergo conventional laparoscopic surgery. In this group,the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.

Locations

Country	Name	City	State
China	Ruijin Hospital North	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Ruijin Hospital	Changhai Hospital, Fudan University, RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Song Z, Li Y, Liu K, Jiang Y, Shi Y, Ji X, Zhang T, Wu H, Shi Y, Zhao R. Clinical and oncologic outcomes of single-incision laparoscopic surgery for right colon cancer: a propensity score matching analysis. Surg Endosc. 2019 Apr;33(4):1117-1123. doi: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Postoperative complications rate 30 days after surgery	30 days after surgery
Secondary	Operative time	Operative time(minutes)	intraoperative
Secondary	Intraoperative blood loss	Estimated blood loss(milliliters,ml)	intraoperative
Secondary	Incision length	Incision length(centimeters,cm)	intraoperative
Secondary	Lymph node detection	Lymph nodes harvested(numbers)	14 days after surgery
Secondary	Incisal margin	Length of proximal and distal margin (centimeters,cm)	14 days after surgery
Secondary	Tumor size	The diameter of tumors(centimeters,cm)	14 days after surgery
Secondary	Length of stay	Duration of hospital stay(days after surgery)	1-14 days after surgery
Secondary	Postoperative recovery course	Time to first ambulation, flatus, liquid diet and soft diet (hours after surgery)	1-14 days after surgery
Secondary	Pain score	Postoperative pain is recorded using the visual analog scale (VAS) pain score (0-10 points)tool on postoperative day 1, 2, 3 and the day of discharge	1-3 days after surgery
Secondary	3-year disease free survival rate	3-year disease free survival rate	36 months after surgery
Secondary	5-year overall survival rate	5-year overall survival rate	60 months after surgery