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Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ji Won Park, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01269060
First received: January 3, 2011
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
 Procedure: Single Incision Laparoscopic Surgery
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Harvested numbers of lymph node [ Time Frame: Within the first 7 days (plus or minus 3 days) after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Postoperative mortality, morbidity [ Time Frame: Within 30 days after operation ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single incision sigmoidectomy
Single incision laparoscopic sigmoidectomy for sigmoid colon cancer
 Procedure: Single Incision Laparoscopic Surgery
Single Incision Laparoscopic Sigmoidectomy
Other Name: Embryonic NOTES Sigmoidectomy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269060

Locations
Korea, Republic of
National Cancer Center Hospital
Goyang, Gyeonggi-do, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Study Chair: Jae Hwan Oh, Dr. PhD. Center for Colorectal Cancer, National Cancer Center Korea
  More Information

No publications provided

Responsible Party: Ji Won Park, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01269060     History of Changes
Other Study ID Numbers: NCCCTS-484
Study First Received: January 3, 2011
Last Updated: August 2, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by National Cancer Center, Korea:
Colorectal Cancer, laparoscopic surgery

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013