Vaginal Transluminal Endoscopic Sacrocolpopexy

Vaginal Transluminal Endoscopic Sacrocolpopexy: A Minimal Invasive Approach for Pelvic Organ Prolapse

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: V NOTES Sacrocolpopexy

Detailed Description

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 and gave written informed consent were included in the study. Demographic data, age, medical and surgical history, body mass index (BMI), operation time, preoperative and postoperative haemoglobin levels, perioperative complications and length of hospital stay were collected. 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).

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kartal
    • Istanbul, Kartal, Turkey
      • Kartal Dr. Lütfi Kirdar City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: V NOTES Sacrocolpopexy arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Investigators: Principal Investigator: Elif Gundogdu, M.D.Dr, Kartal Dr. Lütfi Kirdar City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 2022/514/222/30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No