Port Size and Post-Operative Pain Perception by Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2017-11-16

Brief Summary

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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).

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Detailed Description

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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

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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8mm Port

Participates will be randomized to have an 8 mm assistant port used during their surgery. The participate will be asked to specify the point that represents their level of perceived pain intensity and mark it on the scale at four time points: baseline pain prior to the procedure in the pre-operatively holding area, 4 to 6 hours post operatively, on Post Operative Day 1 (POD1). The final pain assessment will be at the two weeks postoperative clinic visit.

Group Type ACTIVE_COMPARATOR

8mm port

Intervention Type PROCEDURE

Participate in this arm will have their procedure performed with an 8mm laparoscopic port.

12mm Port

Participates will be randomized to have an 12mm assistant port used during their surgery. The participate will be asked to specify the point that represents their level of perceived pain intensity and mark it on the scale at four time points: baseline pain prior to the procedure in the pre-operatively holding area, 4 to 6 hours post operatively, on Post Operative Day 1 (POD1). The final pain assessment will be at the two weeks postoperative clinic visit.

Group Type EXPERIMENTAL

12mm port

Intervention Type PROCEDURE

Participate in this arm will have their procedure performed with a 12mm laparoscopic port.

Interventions

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8mm port

Participate in this arm will have their procedure performed with an 8mm laparoscopic port.

Intervention Type PROCEDURE

12mm port

Participate in this arm will have their procedure performed with a 12mm laparoscopic port.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* laparoscopic surgery for pelvic organ prolapse.
* proficiency in English .

Exclusion Criteria

* Not proficiency in English
* Previous participation/randomization in the study at a previous visit
* Pregnant women cannot participate
* History of abdominal wall pain
* Chronic pain patients

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No