Laparoscopic Central and Anterior Compartment Prolapse Surgery: A Meshless Sacrocolpopexy Technique

NCT05558852 | Unknown

• 1 other identifier: 84/2022
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Mesh is widely applied in the abdominal approach to pelvic organ prolapse surgery, and sacrocolpopexy-sacrohysteropexy is the gold standard application, particularly for central compartment abnormalities. There are numerous disadvantages associated with the use of mesh. In some studies, the rate of mesh complications (such as mesh erosion, contraction, response, and pain) can reach 20%. This surgical approach aims to provide laparoscopic repair of pelvic organ prolapse without the use of mesh, hence avoiding the difficulties associated with mesh.

Conditions

Prolapse Uterovaginal; Prolapse Bladder; Laparoscopy

Keywords

Laparoscopy; Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (5)

• Visual analog Scale

  Pain Scale of 0 to 10, aiming that the operation itself leaves no pain.

  6 months after the operation

• POP-Q classification

  examination of pelvis organs, aiming that the vaginal cuff stays at -2 level and no recur.

  6 months after the operation

• PQOL

  Aiming to see the increased quality of life by the questionnaire which is given preoperatively and postoperative 6th month.

  6 months after the operation

• FSFI

  Aiming to see the increased quality of sexual life by the questionnaire which is given preoperatively and postoperative 6th month.

  6 months after the operation

• Urinary Incontinance

  Questioning and examining patient after surgery related to urinary incontinancy complaint, and evaluating the incontinancy state with questionnaires of Incontinence Impact Questionnaire (IIQ-7) and Urinary Distress Inventory (UDI-6)

  6 months after the operation

Study Arms (1)

Meshless Approach

EXPERIMENTAL

Laparoscopic Sacrocolpopexy in central or anterior compartment prolapse.

Procedure: Laparoscopic Meshless Sacrocolpopexy Technique

Interventions

Laparoscopic Meshless Sacrocolpopexy Technique PROCEDURE

Meshless sacrocolpopexy: laparoscopic approach to central and anterior compartment prolapse

Meshless Approach

Eligibility Criteria

• Age: 30 Years - 80 Years
• Gender Eligibility Details: Female patients in between 30 to 80 years old with a symptomatic vaginal cuff/uterine prolapse and/or cyctocele
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients older than 30 years and younger than 80 years old
• Patients who provided written consent for this surgical procedure

You may not qualify if:

• Patients who cannot obtain anesthesia approval for laparoscopic surgery
• Patients with asymptomatic pelvic organ prolapse
• Patients with active pelvic inflammatory disease
• Patients who have a confirmed or suspected pregnancy or malignancy
• Patients who have an unexplored abnormal cervical-uterine cytology

Sponsors & Collaborators

• Zeynep Kamil Maternity and Pediatric Research and Training Hospital: lead

Study Sites (1)

Zeynep Kamil Maternity and Childrens Training and Research Hospital

Istanbul, 34660, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Resul Karakus, MD

CONTACT

05059164216; resul-karakus@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Only one attending surgeon will operate the all participants. The patients will be evaluated pre-operatively by the surgeon and postoperatively 6th months by a different physician ( who is practicing as a gynecologist in the same hospital).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Anticipated 25 patients will be evaluated and operated with meshless method.

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: September 28, 2022
• Study Start: July 15, 2022
• Primary Completion: October 15, 2022
• Study Completion: April 15, 2023
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

TU (1)