Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single port laparoscopic surgery

Group Type EXPERIMENTAL

Single port laparoscopic surgery

Intervention Type PROCEDURE

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

Conventional laparoscopic surgery

Group Type ACTIVE_COMPARATOR

Conventional laparoscopic surgery

Intervention Type PROCEDURE

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

Interventions

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Single port laparoscopic surgery

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

Intervention Type PROCEDURE

Conventional laparoscopic surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No