Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

Colorectal Cancer Clinical Trial

Official title:

Phase 2 Study of Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269060
• Other study ID #: NCCCTS-484
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2011
• Last updated: August 2, 2012
• Start date: January 2011
• Est. completion date: August 2011

Study information

• Verified date: August 2012
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Single Incision Laparoscopic Surgery
Single Incision Laparoscopic Sigmoidectomy

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center Hospital	Goyang	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harvested numbers of lymph node		Within the first 7 days (plus or minus 3 days) after surgery	Yes
Secondary	Postoperative mortality, morbidity		Within 30 days after operation	Yes