Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

National Cancer Center, Korea48 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

Single Incision Laparoscopic SurgeryPROCEDURE

Single Incision Laparoscopic Sigmoidectomy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National Cancer Center Hospital

Goyang-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Harvested numbers of lymph node

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

Secondary Outcomes

Postoperative mortality, morbidity

Time frame: Within 30 days after operation

Data from ClinicalTrials.gov

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