Radial Reload Laparoscopic LAR Case Series

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-11-30

Brief Summary

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To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary endpoints.

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Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Covidien Radial Reload Stapler with Tri-Staple Technology

Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic LAR or proctosigmoidectomy

Group Type EXPERIMENTAL

Covidien Radial Reload Stapler with Tri-Staple Technology

Intervention Type DEVICE

Case series of patients arlaedy selected to undergo a laparoscopic LAR using the Radial Reload stapler

Interventions

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Covidien Radial Reload Stapler with Tri-Staple Technology

Case series of patients arlaedy selected to undergo a laparoscopic LAR using the Radial Reload stapler

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. The subject is able to understand and sign Informed Consent Form.
2. The subject is between 18-85 years of age.
3. The subject is anticipated to undergo a resection of the rectum with anastomosis below the peritoneal reflection.
4. The subject is anticipated to undergo mobilization and stapling of the rectum laparoscopically.

Exclusion Criteria

1. Any female patient, who is pregnant, suspected pregnant, or nursing.
2. The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
3. The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No