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

Phase 2
18 Years
80 Years
Not Enrolling
Colorectal Cancer

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Trial Information

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

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.

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

- Not eligible to participate for other reasons by doctor's decision

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Harvested numbers of lymph node

Outcome Time Frame:

Within the first 7 days (plus or minus 3 days) after surgery

Safety Issue:


Principal Investigator

Jae Hwan Oh, Dr. PhD.

Investigator Role:

Study Chair

Investigator Affiliation:

Center for Colorectal Cancer, National Cancer Center Korea


Korea: Institutional Review Board

Study ID:




Start Date:

January 2011

Completion Date:

August 2011

Related Keywords:

  • Colorectal Cancer
  • Colorectal Cancer, laparoscopic surgery
  • Colorectal Neoplasms