Single Incision Laparoscopic Colorectal Surgery (SILCS)

October 7, 2022 updated by: Zhao Ren, Ruijin Hospital

Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease

Single incision laparoscopic surgery (SILS) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. Through the development of single hole laparoscopic colorectal cancer radical surgery and clinical study and follow up accordingly, evaluating the feasibility, surgical effectiveness and economy help to promote the popularization and application of single hole laparoscopic techniques in the field.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients with colorectal cancer will randomly divided into single incision laparoscopic surgery group and conditional laparoscopic surgery group. The operation time, blood loss, the incidence of lymph node , the number of postoperative complications, the gastrointestinal function recovery time, postoperative hospital stay，the number of local recurrence and distant metastasis, survival rate and the total cost of hospitalization will be evaluated to confirm the feasibility of single incision laparoscopic surgery is effective and economical. It is worthy of clinical application.

Study Type

Interventional

Enrollment (Actual)

200

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
      • Shanghai, Shanghai, China, 201821
        • 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 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 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 7th 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) >30 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
Experimental: single incision laparoscopic surgery
patients with colorectal cancer and undergo single incision laparoscopic surgery
Procedure: single incision laparoscopic surgery
Patients undergo single incision laparoscopic surgery
Placebo Comparator: Conventional laparoscopic surgery
patients with colorectal cancer and undergo conventional laparoscopic surgery
Procedure: conventional laparoscopic surgery
Patients undergo conventional laparoscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early morbidity rate
Time Frame: 30 days
morbidity rate 30 days after surgery
30 days

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

Investigators

  • Study Chair: Liu Kun, 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 (Actual)

June 28, 2017

Primary Completion (Actual)

June 29, 2019

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

May 10, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Actual)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RJ-SILS-CRC2017
  • SHSDC (Other Identifier: SHSDC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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