Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

National Cancer Center (NCC)

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Procedure: Single Incision Laparoscopic Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01269060

NCCCTS-484

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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