Vaginal Transluminal Endoscopic Sacrocolpopexy

NCT06004089 | Completed

• 1 other identifier: 2022/514/222/30
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the outcomes of V-NOTES sacrocolpopexy following vaginal hysterectomy, focusing on perioperative and early postoperative results. The impact of V-NOTES sacrocolpopexy on patients' quality of life is investigated using validated assessment tools. Additionally, operative time, complications, pain scores were assessed.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

• The impact of V-NOTES sacrocolpopexy on patients' quality of life regarding daily activities and emotional health

  The impact of pelvic floor function on daily activities and emotional health of life was evaluated before and 1 month after surgery with the Turkish-validated Pelvic Floor Impact Questionnaire (PFIQ-7). This study aimed to evaluate the outcomes of V-NOTES sacrocolpopexy following vaginal hysterectomy, focusing on perioperative and early postoperative results.

  1 month

• The impact of V-NOTES sacrocolpopexy on patients' quality of life regarding level of discomfort

  The level of discomfort associated with symptoms was evaluated before and 1 month after surgery with the Turkish-validated Pelvic Floor Impact Questionnaire (PFIQ-7). This study aimed to evaluate the outcomes of V-NOTES sacrocolpopexy following vaginal hysterectomy, focusing on perioperative and early postoperative results.

  1 month

Study Arms (1)

V NOTES Sacrocolpopexy arm

EXPERIMENTAL

V-NOTES sacrocolpopexy was performed who met the eligibility criteria and gave written informed consent. Pelvic organ prolapse quantification (POP-Q) scores were evaluated before and 1 month after surgery. Quality of life was evaluated before and 1 month after surgery with the Turkish-validated Pelvic Floor Impact Questionnaire (PFIQ-7) and Pelvic Floor Distress Inventory (PFDI-20).

Procedure: V NOTES Sacrocolpopexy

Interventions

V NOTES Sacrocolpopexy PROCEDURE

The procedure involved a single-port laparoscopic surgery through the vaginal route, aiming to restore pelvic floor function by suspending the vagina to the anterior longitudinal ligament. The surgical approach differs from conventional methods, as these procedures are conducted through abdominal or vaginal routes without the aid of laparoscopic cameras, However, in our approach, we uniquely combine the widely acknowledged gold standard sacrocolpopexy procedure using vaginal route with laparoscopic camera assistance. No experimental drugs or devices were employed; only the surgical approach was modified.

V NOTES Sacrocolpopexy arm

Eligibility Criteria

• Age: 45 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who presented to the obstetrics and gynecology outpatient clinic with complaints related to pelvic organ prolapse, had stage III or IV prolapse according to POP-Q classification, were between 45 and 79 years old, had no contraindications for pneumoperitoneum and Trendelenburg position, and were eligible to perform transvaginal NOTES were included in the study.

You may not qualify if:

• Patients with previous pelvic inflammatory disease, deep endometriosis, severe pelvic adhesions, and patients who are at risk of gynecological malignancy and are not suitable for transvaginal surgery were not included in the study.

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr. Lutfi Kirdar City Hospital

Istanbul, Kartal, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Study Officials

• Elif Gundogdu, M.D.Dr

  Kartal Dr. Lutfi Kirdar City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist doctor

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 22, 2023
• Study Start: October 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)