Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer (mSILSC)

September 2, 2021 updated by: Zhao Ren, Ruijin Hospital

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

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）.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 201801
        • Ruijin Hospital North

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Ⅰ-Ⅲ
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Laparoscopic Surgery
Patients with colorectal cancer undergo conventional laparoscopic surgery（multi-ports）.
Procedure: 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.
Other Names:
  • CLSC
Experimental: Single-incision Laparoscopic Surgery
Patients with colorectal cancer undergo single-incision laparoscopic surgery.
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.
Other Names:
  • SILSC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 30 days after surgery
Postoperative complications rate 30 days after surgery
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: intraoperative
Operative time（minutes）
intraoperative
Intraoperative blood loss
Time Frame: intraoperative
Estimated blood loss（milliliters，ml）
intraoperative
Incision length
Time Frame: intraoperative
Incision length（centimeters，cm）
intraoperative
Lymph node detection
Time Frame: 14 days after surgery
Lymph nodes harvested（numbers）
14 days after surgery
Incisal margin
Time Frame: 14 days after surgery
Length of proximal and distal margin （centimeters，cm）
14 days after surgery
Tumor size
Time Frame: 14 days after surgery
The diameter of tumors（centimeters，cm）
14 days after surgery
Length of stay
Time Frame: 1-14 days after surgery
Duration of hospital stay（days after surgery）
1-14 days after surgery
Postoperative recovery course
Time Frame: 1-14 days after surgery
Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）
1-14 days after surgery
Pain score
Time Frame: 1-3 days after surgery
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
3-year disease free survival rate
Time Frame: 36 months after surgery
3-year disease free survival rate
36 months after surgery
5-year overall survival rate
Time Frame: 60 months after surgery
5-year overall survival rate
60 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Changhai Hospital
Fudan University
RenJi Hospital

Investigators

  • Study Chair: Kun Liu, MD, ruijin hospitla North

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

August 14, 2018

First Submitted That Met QC Criteria

August 14, 2018

First Posted (Actual)

August 16, 2018

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJ-mSILSC-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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