Comparative Study of Circular Stapling Instruments

Comparative Study of Circular Stapling Instruments Concerning the Risk of Anastomotic Dehiscence After Anterior Resection for Rectal Cancer.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00399009

Enrollment

880

Registered

2006-11-14

Start date

2004-01-31

Completion date

2007-11-30

Last updated

2008-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak, Rectal Cancer

Keywords

Circular stapling devices, anastomotic leak, anastomotic dehiscence, rectal cancer

Brief summary

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.

Interventions

DEVICEAutoSuture Premium Plus CEEA/Ethicon Proximate ILS

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age over 18 * Anterior resection for Rectal Cancer * Informed consent

Exclusion criteria

* Can not give informed consent * Patient can not be followed

Design outcomes

Primary

Measure	Time frame
Clinical anastomotic leak	—

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026