Comparative Study of Circular Stapling Instruments

Uppsala University Hospital880 enrolled

Overview

After removing the rectum at surgery, bowel continuity can sometimes be restored by an anastomosis between the anus and the bowel. This anastomosis is most commonly created by the use of surgical circular stapling instruments. In a retrospective pilot study the risk of developing an acute leak in the anastomosis was increased with one of the most commonly used instruments in Sweden as compared to the other brand in use. In the current study the patient is randomized to either one of the instruments after a resection of the rectum for rectal cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

880

Conditions

Anastomotic Leak Rectal Cancer

Interventions

AutoSuture Premium Plus CEEA/Ethicon Proximate ILSDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age over 18 * Anterior resection for Rectal Cancer * Informed consent Exclusion Criteria: * Can not give informed consent * Patient can not be followed

Locations (1)

Uppsala University Hospital

Uppsala, Sweden

Outcomes

Primary Outcomes

Clinical anastomotic leak

Data from ClinicalTrials.gov

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