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

Primary Purpose

Colorectal Cancer, Colonic Neoplasms, Rectal Neoplasms

Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Single-incision Laparoscopic Surgery
Conventional Laparoscopic Surgery
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring SILS, colorectal cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ruijin Hospital North

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Laparoscopic Surgery

Single-incision Laparoscopic Surgery

Arm Description

Patients with colorectal cancer undergo conventional laparoscopic surgery(multi-ports).

Patients with colorectal cancer undergo single-incision laparoscopic surgery.

Outcomes

Primary Outcome Measures

Postoperative complications
Postoperative complications rate 30 days after surgery

Secondary Outcome Measures

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

Full Information

First Posted
August 14, 2018
Last Updated
September 2, 2021
Sponsor
Ruijin Hospital
Collaborators
Changhai Hospital, Fudan University, RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03633539
Brief Title
Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Acronym
mSILSC
Official Title
Multi-center Prospective Randomized Controlled Study of the Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No research funds were raised
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
Changhai Hospital, Fudan University, RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colonic Neoplasms, Rectal Neoplasms, Colon Disease, Colon Cancer, Rectal Cancer, Rectal Diseases
Keywords
SILS, colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Laparoscopic Surgery
Arm Type
Active Comparator
Arm Description
Patients with colorectal cancer undergo conventional laparoscopic surgery(multi-ports).
Arm Title
Single-incision Laparoscopic Surgery
Arm Type
Experimental
Arm Description
Patients with colorectal cancer undergo single-incision laparoscopic surgery.
Intervention Type
Procedure
Intervention Name(s)
Single-incision Laparoscopic Surgery
Other Intervention Name(s)
SILSC
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional Laparoscopic Surgery
Other Intervention Name(s)
CLSC
Intervention Description
Patients undergo conventional laparoscopic surgery. In this group,the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.
Primary Outcome Measure Information:
Title
Postoperative complications
Description
Postoperative complications rate 30 days after surgery
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
Operative time
Description
Operative time(minutes)
Time Frame
intraoperative
Title
Intraoperative blood loss
Description
Estimated blood loss(milliliters,ml)
Time Frame
intraoperative
Title
Incision length
Description
Incision length(centimeters,cm)
Time Frame
intraoperative
Title
Lymph node detection
Description
Lymph nodes harvested(numbers)
Time Frame
14 days after surgery
Title
Incisal margin
Description
Length of proximal and distal margin (centimeters,cm)
Time Frame
14 days after surgery
Title
Tumor size
Description
The diameter of tumors(centimeters,cm)
Time Frame
14 days after surgery
Title
Length of stay
Description
Duration of hospital stay(days after surgery)
Time Frame
1-14 days after surgery
Title
Postoperative recovery course
Description
Time to first ambulation, flatus, liquid diet and soft diet (hours after surgery)
Time Frame
1-14 days after surgery
Title
Pain score
Description
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
Time Frame
1-3 days after surgery
Title
3-year disease free survival rate
Description
3-year disease free survival rate
Time Frame
36 months after surgery
Title
5-year overall survival rate
Description
5-year overall survival rate
Time Frame
60 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun Liu, MD
Organizational Affiliation
Ruijin Hospitla North
Official's Role
Study Chair
Facility Information:
Facility Name
Ruijin Hospital North
City
Shanghai
ZIP/Postal Code
201801
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30043168
Citation
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: 10.1007/s00464-018-6370-2. Epub 2018 Jul 24.
Results Reference
result

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Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

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