Prospective Randomized Study of SILS Versus CLS for Rectal 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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-10-31

Brief Summary

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Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma. However, the feasibility of this procedure in rectal surgery has not been determined yet. The aim of this study is to evaluate our initial experience using single port access in laparoscopic rectal surgery.

Design: randomized, prospective clinical study Patients: 40 patients

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Detailed Description

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Conditions

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Rectal Cancer Adenocarcinoma

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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SILS-group

20 patients undergoing Single Incision Laparoscopic Surgery

Group Type EXPERIMENTAL

Single Incision Laparoscopic Surgery

Intervention Type PROCEDURE

Single incision laparoscopic surgery for rectal cancer

CLS-group

20 patients undergoing Conventional Laparoscopic Surgery for rectal cancer

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Single Incision Laparoscopic Surgery

Single incision laparoscopic surgery for rectal cancer

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients \> 18 years of age.
* ASA I-III.
* Tumor-location: maximum 15 cm from the anal verge.
* No involvement of neighbouring organs.
* No distant metastasis.