Port Size and Post-Operative Pain Perception by Patients

Study Overview
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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).

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).

Official Title
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Port Size and Post-Operative Pain Perception by Patients

Conditions
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Pain

Intervention / Treatment
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* Procedure: 8mm port
* Procedure: 12mm port


Participation Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 8mm Port<br>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. | Procedure: 8mm port<br>* Participate in this arm will have their procedure performed with an 8mm laparoscopic port.<br>|
| Experimental: 12mm Port<br>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. | Procedure: 12mm port<br>* Participate in this arm will have their procedure performed with a 12mm laparoscopic port.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants will be asked to specify the point that represents their level of perceived pain intensity and mark it on the VAS at four time points. | Measured with Visual Analog Scale (VAS) for pain at 1) baseline pain prior to the procedure in the pre-operatively holding area, 2) 4-6 hours post-operatively in the post-anesthesia care unit (PACU), 3) on post-operative day 1(POD1) and 4) once two weeks post operatively. | 2 weeks post-op visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| What is the physician's perception of operative difficulty throughout the case? Determination of physician struggle and frustration will be documented. | This will be measured by recording the time the first suture is placed when the physician asks for the mesh, to the time the incision is closed. | Day of surgery |