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

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ClinicalTrials.gov Identifier: NCT03633539
Recruitment Status : Withdrawn (No research funds were raised)
First Posted : August 16, 2018
Last Update Posted : September 10, 2021
Sponsor:
Collaborators:
Changhai Hospital
Fudan University
RenJi Hospital
Information provided by (Responsible Party):
Zhao Ren, Ruijin Hospital

Study Description
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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）.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colonic Neoplasms Rectal Neoplasms Colon Disease Colon Cancer Rectal Cancer Rectal Diseases Procedure: Single-incision Laparoscopic Surgery Procedure: Conventional Laparoscopic Surgery Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center Prospective Randomized Controlled Study of the Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025
Arms and Interventions
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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 Name: 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 Name: SILSC


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: 30 days after surgery ]
    Postoperative complications rate 30 days after surgery


Secondary Outcome Measures :
  1. Operative time [ Time Frame: intraoperative ]
    Operative time（minutes）

  2. Intraoperative blood loss [ Time Frame: intraoperative ]
    Estimated blood loss（milliliters，ml）

  3. Incision length [ Time Frame: intraoperative ]
    Incision length（centimeters，cm）

  4. Lymph node detection [ Time Frame: 14 days after surgery ]
    Lymph nodes harvested（numbers）

  5. Incisal margin [ Time Frame: 14 days after surgery ]
    Length of proximal and distal margin （centimeters，cm）

  6. Tumor size [ Time Frame: 14 days after surgery ]
    The diameter of tumors（centimeters，cm）

  7. Length of stay [ Time Frame: 1-14 days after surgery ]
    Duration of hospital stay（days after surgery）

  8. Postoperative recovery course [ Time Frame: 1-14 days after surgery ]
    Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）

  9. 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

  10. 3-year disease free survival rate [ Time Frame: 36 months after surgery ]
    3-year disease free survival rate

  11. 5-year overall survival rate [ Time Frame: 60 months after surgery ]
    5-year overall survival rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633539


Locations
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China
Ruijin Hospital North
Shanghai, China, 201801
Sponsors and Collaborators
Ruijin Hospital
Changhai Hospital
Fudan University
RenJi Hospital
Investigators
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Study Chair: Kun Liu, MD Ruijin Hospitla North
More Information
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Publications of Results:

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Responsible Party: Zhao Ren, Chief Physicion, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03633539    
Other Study ID Numbers: RJ-mSILSC-2018
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhao Ren, Ruijin Hospital:
SILS
colorectal cancer
Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Rectal Diseases
Colonic Diseases
Intestinal Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases