Multicenter Single-port Colectomy RCT

NCT ID: NCT01480128

Last Updated: 2020-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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This clinical trial is a multicenter prospective randomized trial to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment.

Conditions

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Colon Neoplasms

Interventions

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Single-port

Single-port laparoscopic colon resection

Intervention Type PROCEDURE

Multi-port

Multi-port laparoscopic colon resection

Intervention Type PROCEDURE

Other Intervention Names

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Single-incision SILS Octoport laparoscopy

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyunghee University

OTHER

Sponsor Role collaborator

Chonnam National University

OTHER

Sponsor Role collaborator

The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Hyung-Jin Kim

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun-Gi Kim, MD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

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St. Vincent's hospital

Suwon, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 33141277 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32209897 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28916955 (View on PubMed)

Other Identifiers

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SPA-2011

Identifier Type: -

Identifier Source: org_study_id

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