Measuring Abdominal Wall Compliance During Gynecologic Laparoscopic Surgery

NCT05012956 | Completed

• 1 other identifier: S65329
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

• Intra-abdominal pressure (IAC)

  Measured as part of the surgery by the insufflator device. \[mmHg\]

  During surgery

• Reflective marker displacement (RMD)

  Measured by an infrared camera and reflective markers attached to the abdominal wall. \[mm\]

  Druign surgery

Secondary Outcomes (3)

• Pelvic organ quantification score

  pre-surgery examination

• Age

  pre-srugery

• BMI

  pre-surgery

Study Arms (2)

POP group

ACTIVE COMPARATOR

Pelvic organ prolapse patients enrolled for sacrocolpopexy surgery at UZ Leuven.

Procedure: Laparoscopic sacrocolpopexy

Control group

ACTIVE COMPARATOR

Patients assigned to gynecologic laparoscopic surgery, other than sacrocolpopexy, at UZ Leuven.

Procedure: gynecologic laparoscopic surgery

Interventions

Laparoscopic sacrocolpopexy PROCEDURE

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.

POP group

gynecologic laparoscopic surgery PROCEDURE

Gynecologic laparoscopic surgery at UZ Leuven, other than sacrocolpopexy

Control group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients assigned to gynecologic laparoscopic surgery at UZ Leuven.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

Ann-Sophie Page

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Group 1: pelvic organ prolapse patients Group 2: patients assigned to gynecologic laparoscopic surgery, other than pelvic organ prolapse, at UZ Leuven.

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 19, 2021
• Study Start: October 12, 2022
• Primary Completion: October 30, 2023
• Study Completion: November 27, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)