NCT03633539

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）.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
2 years until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

August 14, 2018

Last Update Submit

September 2, 2021

Conditions

Colorectal CancerColonic NeoplasmsRectal NeoplasmsColon DiseaseColon CancerRectal CancerRectal Diseases

Keywords

SILScolorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Postoperative complications rate 30 days after surgery

    30 days after surgery

Secondary Outcomes (11)

  • Operative time

    intraoperative

  • Intraoperative blood loss

    intraoperative

  • Incision length

    intraoperative

  • Lymph node detection

    14 days after surgery

  • Incisal margin

    14 days after surgery

  • +6 more secondary outcomes

Study Arms (2)

Conventional Laparoscopic Surgery

ACTIVE COMPARATOR

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

Procedure: Conventional Laparoscopic Surgery

Single-incision Laparoscopic Surgery

EXPERIMENTAL

Patients with colorectal cancer undergo single-incision laparoscopic surgery.

Procedure: Single-incision Laparoscopic Surgery

Interventions

Single-incision Laparoscopic SurgeryPROCEDURE

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.

Also known as: SILSC
Single-incision Laparoscopic Surgery
Conventional Laparoscopic SurgeryPROCEDURE

Patients undergo conventional laparoscopic surgery. In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.

Also known as: CLSC
Conventional Laparoscopic Surgery

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital North

Shanghai, 201801, China

Location

Related 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: 10.1007/s00464-018-6370-2. Epub 2018 Jul 24.

    PMID: 30043168RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal NeoplasmsColonic DiseasesRectal Diseases

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal Diseases

Study Officials

  • Kun Liu, MD

    Ruijin Hospitla North

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physicion

Study Record Dates

First Submitted

August 14, 2018

First Posted

August 16, 2018

Study Start

August 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2025

Last Updated

September 10, 2021

Record last verified: 2021-09

Locations

CN(1)