Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01269060
• Date of registration: 03/01/2011
• Prospective Registration: No
• Primary sponsor: National Cancer Center, Korea
• Public title: Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery
• Scientific title: Phase 2 Study of Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery
• Date of first enrolment: January 2011
• Target sample size: 48
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01269060
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Korea, Republic of

Contacts

• Name: Jae Hwan Oh, Dr. PhD.
• Affiliation: Center for Colorectal Cancer, National Cancer Center Korea

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Colorectal Cancer

Intervention(s)

Procedure: Single Incision Laparoscopic Surgery

Primary Outcome(s)

Harvested numbers of lymph node [Time Frame: Within the first 7 days (plus or minus 3 days) after surgery]

Secondary Outcome(s)

Postoperative mortality, morbidity [Time Frame: Within 30 days after operation]

Secondary ID(s)

NCCCTS-484

Source(s) of Monetary Support

Please refer to primary and secondary sponsors