NCT03151733

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 20, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 28, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2019

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

March 20, 2017

Last Update Submit

December 7, 2024

Conditions

Laparoscopic Colorectal Surgery

Keywords

SILScolorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Early morbidity rate

    morbidity rate 30 days after surgery

    30 days

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)

single incision laparoscopic surgery

EXPERIMENTAL

patients with colorectal cancer and undergo single incision laparoscopic surgery

Procedure: single incision laparoscopic surgery

Conventional laparoscopic surgery

PLACEBO COMPARATOR

patients with colorectal cancer and undergo conventional laparoscopic surgery

Procedure: conventional laparoscopic surgery

Interventions

single incision laparoscopic surgeryPROCEDURE

Patients undergo single incision laparoscopic surgery

single incision laparoscopic surgery
conventional laparoscopic surgeryPROCEDURE

Patients undergo conventional laparoscopic surgery

Conventional laparoscopic surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ruijin hospital North

Shanghai, Shanghai Municipality, 201821, China

Location

Related Publications (3)

  • Aldeghaither S, Zubaidi A, Alkhayal K, Al-Obaid O. Single-incision laparoscopic colorectal surgery: a report of 33 cases in Saudi Arabia. Ann Saudi Med. 2016 Jul-Aug;36(4):282-7. doi: 10.5144/0256-4947.2016.282.

    PMID: 27478914RESULT

  • Song Z, Liu K, Li Y, Shi Y, Jiang Y, Wang C, Chen X, Zhang T, Ji X, Zhao R. Short-Term Outcomes of Single-Incision Laparoscopic Surgery for Colorectal Cancer: A Single-Center, Open-Label, Non-Inferiority, Randomized Clinical Trial. Front Oncol. 2021 Oct 25;11:762147. doi: 10.3389/fonc.2021.762147. eCollection 2021.

    PMID: 34760706DERIVED

  • 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: 30043168DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Liu Kun, MD

    ruijin hospitla North

    STUDY CHAIR

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

March 20, 2017

First Posted

May 12, 2017

Study Start

June 28, 2017

Primary Completion

June 29, 2019

Study Completion

June 29, 2024

Last Updated

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)