Measuring Abdominal Wall Compliance During Gynecologic Laparoscopic Surgery

Pelvic Organ Prolapse Clinical Trial

— AbComp  

Official title:

Measuring Abdominal Wall Compliance During Gynecologic Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05012956
• Other study ID #: S65329
• Status: Completed
• Phase: N/A
• Start date: October 12, 2022
• Est. completion date: November 27, 2023

Study information

• Verified date: May 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 27, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Laparoscopic sacrocolpopexy
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.
• gynecologic laparoscopic surgery
Gynecologic laparoscopic surgery at UZ Leuven, other than sacrocolpopexy

Locations

Country	Name	City	State
Belgium	Ann-Sophie Page	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-abdominal pressure (IAC)	Measured as part of the surgery by the insufflator device. [mmHg]	During surgery
Primary	Reflective marker displacement (RMD)	Measured by an infrared camera and reflective markers attached to the abdominal wall. [mm]	Druign surgery
Secondary	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.	pre-surgery examination
Secondary	Age	Age of the patient	pre-srugery
Secondary	BMI	Body mass index	pre-surgery