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Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

NCT ID: NCT01269060

Last Updated: 2012-08-06

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer

Keywords

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Colorectal Cancer, laparoscopic surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single incision sigmoidectomy

Single incision laparoscopic sigmoidectomy for sigmoid colon cancer

Group Type EXPERIMENTAL

Single Incision Laparoscopic Surgery

Intervention Type PROCEDURE

Single Incision Laparoscopic Sigmoidectomy

Interventions

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Single Incision Laparoscopic Surgery

Single Incision Laparoscopic Sigmoidectomy

Intervention Type PROCEDURE

Other Intervention Names

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Embryonic NOTES Sigmoidectomy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ji Won Park

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae Hwan Oh, Dr. PhD.

Role: STUDY_CHAIR

Center for Colorectal Cancer, National Cancer Center Korea

Locations

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National Cancer Center Hospital

Goyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NCCCTS-484

Identifier Type: -

Identifier Source: org_study_id