Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

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: Colorectal Cancer
• Intervention / Treatment: Procedure: Single Incision Laparoscopic Surgery

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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: Colorectal Cancer, laparoscopic surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NCCCTS-484