Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: Single Incision Laparoscopic Surgery

• Registration Number: NCT01269060
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-04
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-02
• Last Update Posted: 2012-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single incision sigmoidectomy	Single Incision Laparoscopic Surgery	Single incision laparoscopic sigmoidectomy for sigmoid colon cancer

Primary Outcome Measures

Name	Time	Method
Harvested numbers of lymph node	Within the first 7 days (plus or minus 3 days) after surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative mortality, morbidity	Within 30 days after operation

Trial Locations

Locations (1)

National Cancer Center Hospital; 🇰🇷 Goyang, Gyeonggi-do, Korea, Republic of