Phase 3 N=15 Randomized Single-blind Treatment

Intraoperative Trocar Slippage Study

Trocar Slippage

Bottom Line

View on ClinicalTrials.gov: NCT01476748 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Trocar Slippages With LaproStop — 1; 2; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: LaproStop (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Brigham and Women's Hospital
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Trocar Slippages With LaproStop	1; 2; 3	—
SECONDARY Trocar Slippages Without LaproStop	0; 2; 4	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01476748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.