Intraoperative Trocar Slippage Study

Mass General Brigham

Status and phase: Completed; Phase 3

Conditions: Trocar Slippage

Treatments: Device: LaproStop

Study type: Interventional

Funder types: Other

Identifiers

NCT01476748

2011P001825

Details and patient eligibility

About

The purpose of this study is to find out how much a trocar might slide during a typical laparoscopic hysterectomy. We also want to find out if there is a difference between how much three commonly used trocars slide and if a device called LaproStop has an effect on the slippage.

Patients will be randomly assigned into the different trocar groups. After this assignment has been made, we will then assign the Laprostop to one of the two trocars by chance.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Women undergoing a hysterectomy at Brigham and Women's Hospital and Faulkner Hospital.

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

15 participants in 3 patient groups

Ethicon Xcel Trocars

Active Comparator group

Description:

Ethicon Xcel trocars will be used in this arm with Laprostop device

Treatment:

Device: LaproStop

Covidien Veraport Trocars

Active Comparator group

Description:

Covidien Veraport Trocars will be used in this arm with the Laprostop device

Treatment:

Device: LaproStop

Storz Reusable Trocars

Active Comparator group

Description:

Storz Reusable Trocars will be used in this arm with the Laprostop device

Treatment:

Device: LaproStop