Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

NCT01269060 | Completed Phase 2

• 1 other identifier: NCCCTS-484
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer, laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Harvested numbers of lymph node

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

Secondary Outcomes (1)

• Postoperative mortality, morbidity

  Within 30 days after operation

Study Arms (1)

Single incision sigmoidectomy

EXPERIMENTAL

Single incision laparoscopic sigmoidectomy for sigmoid colon cancer

Procedure: Single Incision Laparoscopic Surgery

Interventions

Single Incision Laparoscopic Surgery PROCEDURE

Single Incision Laparoscopic Sigmoidectomy

Also known as: Embryonic NOTES Sigmoidectomy

Single incision sigmoidectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center Hospital

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jae Hwan Oh, Dr. PhD.

  Center for Colorectal Cancer, National Cancer Center Korea

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 4, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 6, 2012

Record last verified: 2012-08

Locations

KR (1)