Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

August 2, 2012 updated by: Ji Won Park, National Cancer Center, Korea

Phase 2 Study of Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

Laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single incision (Embryonic NOTES) colon surgery has been attempted.

However, there are not sufficient evidences for single incision colon surgery in colon cancer.

The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After several randomized clinical trials, laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single Incision (Embryonic NOTES) colon surgery has been attempted. Several studies reported the feasibility of single incision colon surgery.However, there are not sufficient evidences for single incision colon surgery, especially in colon cancer.

The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer. Harvested numbers of lymph node will be assessed for the efficacy and postoperative morbidity and mortality will be assess for the safety.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients should sign a written informed consent
  • Age between 18-80
  • Patients have sigmoid colon cancer that was proved by pathology
  • Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3
  • Adequate kidney function Creatinine ≤ 1.5 mg/dl
  • No remarkable evidence of heart dysfunction and lung dysfunction

Exclusion Criteria:

  • Distant metastasis
  • Tumor diameter > 5 cm
  • Other organ invasion
  • Intestinal obstruction and stent insertion status
  • Patient was used steroid
  • Patients undergo emergency surgery with multiple symptoms
  • Other organ cancer history (except who had radical excision for skin cancer)
  • Presence of other serious disease
  • Mentally ill patients
  • Legally unable to participate in clinical trial
  • Lactating or pregnant women
  • Patients who will obviously fail to regular follow-up visit or will be off study voluntarily
  • Not eligible to participate for other reasons by doctor's decision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single incision sigmoidectomy
Single incision laparoscopic sigmoidectomy for sigmoid colon cancer
Procedure: Single Incision Laparoscopic Surgery
Single Incision Laparoscopic Sigmoidectomy
Other Names:
  • Embryonic NOTES Sigmoidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Harvested numbers of lymph node
Time Frame: Within the first 7 days (plus or minus 3 days) after surgery
Within the first 7 days (plus or minus 3 days) after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative mortality, morbidity
Time Frame: Within 30 days after operation
Within 30 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Study Chair: Jae Hwan Oh, Dr. PhD., Center for Colorectal Cancer, National Cancer Center Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 3, 2011

First Posted (Estimate)

January 4, 2011

Study Record Updates

Last Update Posted (Estimate)

August 6, 2012

Last Update Submitted That Met QC Criteria

August 2, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-484

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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