Vaginal Transluminal Endoscopic Sacrocolpopexy

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06004089
• Other study ID #: 2022/514/222/30
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: August 2023
• Source: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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.

Locations

Country	Name	City	State
Turkey	Kartal Dr. Lutfi Kirdar City Hospital	Istanbul	Kartal

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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