Clinical Trials Directory

Trials / Completed

CompletedNCT02521987

Port Size and Post-Operative Pain Perception by Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Loyola University · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine if there is a difference in pain perception by participants when the assistant port size varies by 50% (8 mm to 12 mm).

Detailed description

Minimally invasive approaches trade a single longer incision for 4-5 smaller incisions that allow abdominal access and abdominal insufflation through "ports". The increase in operative times is mostly due to the need to pass suture, needles, cameras and instruments through the abdominal ports. While, it is intuitive that smaller abdominal ports will result in less pain at the incision site, the port size is also limited by instrument size and the size of the needle. When ports are smaller, it can take a little more time for a needle or instrument to be passed into the port. There is a paucity of research comparing different port sizes as they relate to participate pain and operative time especially in a randomized controlled trial setting. The investigators goal would be to determine if there is a difference in pain perception by patients when the assistant port size varies by 50% (8 mm to 12 mm).

Conditions

Interventions

TypeNameDescription
PROCEDURE8mm portParticipate in this arm will have their procedure performed with an 8mm laparoscopic port.
PROCEDURE12mm portParticipate in this arm will have their procedure performed with a 12mm laparoscopic port.

Timeline

Start date
2015-08-01
Primary completion
2017-11-16
Completion
2017-11-16
First posted
2015-08-13
Last updated
2018-02-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02521987. Inclusion in this directory is not an endorsement.