NCT01480128

Brief Summary

This clinical trial is going to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment, in terms of safety, efficacy, and cost. The investigators hypothesize that the single-port laparoscopic colectomy is not inferior to multiport laparoscopic colectomy.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2011

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

First QC Date

November 23, 2011

Last Update Submit

June 17, 2020

Conditions

Colon Neoplasms

Keywords

Single-portLaparoscopycolectomySingle portcolon cancerminimally invasive surgery

Interventions

Single-portPROCEDURE

Single-port laparoscopic colon resection

Also known as: Single-incision, SILS, Octoport
Multi-portPROCEDURE

Multi-port laparoscopic colon resection

Also known as: laparoscopy

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • colon adenocarcinoma
  • curative resection
  • age : 20 \~ 85

You may not qualify if:

  • distal transverse colon cancer
  • splenic flexure colon cancer
  • descending colon cancer
  • emergency operation
  • obstruction
  • perforation
  • ASA 3 or 4
  • pregnant woman
  • tumor associated with FAP, HNPCC, or IBD
  • distant metastasis
  • adjacent organ invasion
  • synchronous colorectal cancer
  • other malignancy within last five years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's hospital

Suwon, 442-723, South Korea

Location

Related Publications (3)

  • Kang BM, Lee YS, Kim JH, Kim HJ, Lee SC, Kim CW, Lim SW, Kim JG, Lee SH. Quality of life and patient satisfaction after single- and multiport laparoscopic surgery in colon cancer: a multicentre randomised controlled trial (SIMPLE Trial). Surg Endosc. 2021 Nov;35(11):6278-6290. doi: 10.1007/s00464-020-08128-9. Epub 2020 Nov 3.

    PMID: 33141277DERIVED

  • Lee YS, Kim JH, Kim HJ, Lee SC, Kang BM, Kim CW, Lim SW, Lee SH, Kim JG. Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer: The SIMPLE Multicenter Randomized Clinical Trial. Ann Surg. 2021 Feb 1;273(2):217-223. doi: 10.1097/SLA.0000000000003882.

    PMID: 32209897DERIVED

  • Kang BM, Kim HJ, Kye BH, Lee SC, Lee KY, Park SJ, Lee SH, Lim SW, Lee YS, Kim JH, Lee J, Kim MK, Kim JG. Multicenter, randomized single-port versus multiport laparoscopic surgery (SIMPLE) trial in colon cancer: an interim analysis. Surg Endosc. 2018 Mar;32(3):1540-1549. doi: 10.1007/s00464-017-5842-0. Epub 2017 Sep 15.

    PMID: 28916955DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jun-Gi Kim, MD

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 23, 2011

First Posted

November 28, 2011

Last Updated

June 19, 2020

Record last verified: 2020-06

Locations

KR(1)