Measuring Abdominal Wall Compliance During Gynecologic Laparoscopic Surgery (AbComp)
Primary Purpose
Pelvic Organ Prolapse
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Laparoscopic sacrocolpopexy
gynecologic laparoscopic surgery
Sponsored by
About this trial
This is an interventional diagnostic trial for Pelvic Organ Prolapse
Eligibility Criteria
Inclusion Criteria:
- All patients assigned to gynecologic laparoscopic surgery at UZ Leuven.
Exclusion Criteria:
- Patients that are unable to give consent: In case of dementia or other cognitive disorders.
- Patients that are unable to give consent: When they are unable to read and/or interpret the content of the informed consent form (ICF), which is written in Dutch.
- Patients that had had an earlier abdominoplasty or abdominal wall mesh implantation, or other operations that directly affect the biomechanical properties of the abdominal wall.
Sites / Locations
- Ann-Sophie PageRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
POP group
Control group
Arm Description
Pelvic organ prolapse patients enrolled for sacrocolpopexy surgery at UZ Leuven.
Patients assigned to gynecologic laparoscopic surgery, other than sacrocolpopexy, at UZ Leuven.
Outcomes
Primary Outcome Measures
Intra-abdominal pressure (IAC)
Measured as part of the surgery by the insufflator device. [mmHg]
Reflective marker displacement (RMD)
Measured by an infrared camera and reflective markers attached to the abdominal wall. [mm]
Secondary Outcome Measures
Pelvic organ quantification score
Pelvic organ quantification (POP-Q) score, indicating the degree of pelvic organ prolapse (standardized method). The POP-Q score ranges from 0 (no prolapse) to IV (high prolapse). It is expected that a higher POP-Q score results in a higher abdominal wall compliance.
Age
Age of the patient
BMI
Body mass index
Full Information
NCT ID
NCT05012956
First Posted
August 12, 2021
Last Updated
November 2, 2022
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT05012956
Brief Title
Measuring Abdominal Wall Compliance During Gynecologic Laparoscopic Surgery
Acronym
AbComp
Official Title
Measuring Abdominal Wall Compliance During Gynecologic Laparoscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To measure abdominal wall compliance (AWC) during gynaecologic laparoscopy and assess its relation to the pelvic organ prolapse quantification (POP-Q) score of the same individual, and determine a relationship if present.
Detailed Description
To characterize abdominal wall compliance (AWC), sterile reflective markers are attached to the abdominal wall by means of surgical tape, and the movement of these markers will be tracked with an optical tracker device. As during normal surgery, the intra-abdominal pressure (IAP) measured by the insufflator device will be recorded and stored on a secure computer with dedicated software. The pelvic organ quantification (POP-Q) score for each patient is determined pre-surgery as part of the standard of care. A biomechanical model will use reflective marker displacement (RMD) and IAP to calculate AWC. The POP-Q score will then be used to investigate a relation between AWC and degree of prolapse.
It is important to state that the trial does not intervene with the standard of care before- and during surgery. The used equipment is non-invasive and only requires about 5 minutes to be set up before the start of surgery. This set up comprises placing the optical tracker in the operating room such that it has a line of sight on the patient's abdomen and attaching the sterile markers to the abdominal wall. Therefore the trail does not add any additional risk to the surgery.
Each patient scheduled for gynecologic laparoscopy will be asked to participate in the study. If the patient wants to participate, she is presented the informed consent form (ICF). If both patient and clinician in charge sign the ICF, the patient is included in the study. The table below shows the patient specific information stored as part of the study.
Sample size calculation is based on a previous study (S61346), where we measured vaginal wall stiffness (the inverse of compliance) in patients with varying degrees of prolapse. 20 POP patients and 20 control group patients will be included.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: pelvic organ prolapse patients
Group 2: patients assigned to gynecologic laparoscopic surgery, other than pelvic organ prolapse, at UZ Leuven.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
POP group
Arm Type
Active Comparator
Arm Description
Pelvic organ prolapse patients enrolled for sacrocolpopexy surgery at UZ Leuven.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients assigned to gynecologic laparoscopic surgery, other than sacrocolpopexy, at UZ Leuven.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic sacrocolpopexy
Intervention Description
During laparoscopic sacrocolpopexy, the anatomical position of the vaginal vault and cervix (if present) is restored by suturing a surgical mesh to the vaginal cuff or cervix and variable portions of the anterior and posterior vagina, while connecting the other end of the mesh to the anterior longitudinal ligament over the sacrum.
Intervention Type
Procedure
Intervention Name(s)
gynecologic laparoscopic surgery
Intervention Description
Gynecologic laparoscopic surgery at UZ Leuven, other than sacrocolpopexy
Primary Outcome Measure Information:
Title
Intra-abdominal pressure (IAC)
Description
Measured as part of the surgery by the insufflator device. [mmHg]
Time Frame
During surgery
Title
Reflective marker displacement (RMD)
Description
Measured by an infrared camera and reflective markers attached to the abdominal wall. [mm]
Time Frame
Druign surgery
Secondary Outcome Measure Information:
Title
Pelvic organ quantification score
Description
Pelvic organ quantification (POP-Q) score, indicating the degree of pelvic organ prolapse (standardized method). The POP-Q score ranges from 0 (no prolapse) to IV (high prolapse). It is expected that a higher POP-Q score results in a higher abdominal wall compliance.
Time Frame
pre-surgery examination
Title
Age
Description
Age of the patient
Time Frame
pre-srugery
Title
BMI
Description
Body mass index
Time Frame
pre-surgery
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients assigned to gynecologic laparoscopic surgery at UZ Leuven.
Exclusion Criteria:
Patients that are unable to give consent: In case of dementia or other cognitive disorders.
Patients that are unable to give consent: When they are unable to read and/or interpret the content of the informed consent form (ICF), which is written in Dutch.
Patients that had had an earlier abdominoplasty or abdominal wall mesh implantation, or other operations that directly affect the biomechanical properties of the abdominal wall.
Facility Information:
Facility Name
Ann-Sophie Page
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann-Sophie Page, MD
Phone
+3216340017
Email
ann-sophie.page@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Ann-Sophie Page, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Measuring Abdominal Wall Compliance During Gynecologic Laparoscopic Surgery
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