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Completed

NCT Number: NCT01203969

Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer

This randomized trial is designed to identify the safety and efficacy of single port laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

Up to 85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyung Hee University School of Medicine, Neo Medical Center

Seoul, 134-727, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • pathologic proven colon cancer

Exclusion criteria

  • Tumor located in distal transverse colon, splenic flexure, and descending colon
  • distant metastasis
  • acute obstruction and/or perforation
  • associated with FAP or HNPCC
  • synchronous malignancy
  • ASA score 3 or 4
  • pregnancy
  • no consent

Treatment and study plan

Single port laparoscopic surgery

Procedure

laparoscopic surgery in which all the instrument was entered into the abdominal cavity through the single port in the umbilicus

Conventional Laparoscopic Surgery

Procedure

laparoscopic surgery in which each of the instrument were entered into the abdominal cavity through the multiple port in multiple quadrants of abdomen

Primary outcomes

  1. rate of intraoperative complication

    Time frame: 1 day

  2. rate of 30 day morbidity and mortality

    Time frame: 1 month

Secondary outcomes

  1. operation time

    Time frame: 1 day

    operative time

  2. degree of postoperative pain

    Time frame: 5 days

    postoperative pain score using visual analog scale (VAS)

  3. amount of postoperative analgesics usage

    Time frame: 5 days

  4. postoperative functional recovery

    Time frame: 7 days

    time to first passage of flatus time to start diet

  5. Duration of postoperative hospital stay

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 17, 2010
Registry last updated
Feb 3, 2016

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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