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OpenTrials
Completed

NCT Number: NCT01269060

Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

single incision laparoscopic surgery

Procedure

Single Incision Laparoscopic Sigmoidectomy

Other names: Embryonic NOTES Sigmoidectomy

Primary outcomes

  1. Harvested numbers of lymph node

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

Secondary outcomes

  1. Postoperative mortality, morbidity

    Time frame: Within 30 days after operation

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 4, 2011
Registry last updated
Aug 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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