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Port Size and Post-Operative Pain Perception by Patients

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
8mm port
12mm port
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

8mm Port

12mm Port

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 24, 2015
Last Updated
January 30, 2018
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT02521987
Brief Title
Port Size and Post-Operative Pain Perception by Patients
Official Title
Port Size and Post-Operative Pain Perception by Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
November 16, 2017 (Actual)
Study Completion Date
November 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
8mm Port
Arm Type
Active Comparator
Arm Description
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.
Arm Title
12mm Port
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
8mm port
Intervention Description
Participate in this arm will have their procedure performed with an 8mm laparoscopic port.
Intervention Type
Procedure
Intervention Name(s)
12mm port
Intervention Description
Participate in this arm will have their procedure performed with a 12mm laparoscopic port.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2 weeks post-op visit
Secondary Outcome Measure Information:
Title
What is the physician's perception of operative difficulty throughout the case? Determination of physician struggle and frustration will be documented.
Description
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.
Time Frame
Day of surgery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth R Mueller, MD
Organizational Affiliation
Loyola University Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15339758
Citation
Nygaard I, Bradley C, Brandt D; Women's Health Initiative. Pelvic organ prolapse in older women: prevalence and risk factors. Obstet Gynecol. 2004 Sep;104(3):489-97. doi: 10.1097/01.AOG.0000136100.10818.d8.
Results Reference
background
PubMed Identifier
9083302
Citation
Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
Results Reference
background
PubMed Identifier
19037026
Citation
Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol. 2008 Dec;112(6):1201-1206. doi: 10.1097/AOG.0b013e31818ce394.
Results Reference
background
PubMed Identifier
19932417
Citation
McDermott CD, Hale DS. Abdominal, laparoscopic, and robotic surgery for pelvic organ prolapse. Obstet Gynecol Clin North Am. 2009 Sep;36(3):585-614. doi: 10.1016/j.ogc.2009.09.004.
Results Reference
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Port Size and Post-Operative Pain Perception by Patients

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