Vaginal Transluminal Endoscopic Sacrocolpopexy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
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Outcome Measures
Primary Outcome Measures
- The impact of V-NOTES sacrocolpopexy on patients' quality of life regarding daily activities and emotional health [1 month]
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.
- The impact of V-NOTES sacrocolpopexy on patients' quality of life regarding level of discomfort [1 month]
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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kartal Dr. Lutfi Kirdar City Hospital | Istanbul | Kartal | Turkey |
Sponsors and Collaborators
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
Investigators
- Principal Investigator: Elif Gundogdu, M.D.Dr, Kartal Dr. Lutfi Kirdar City Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022/514/222/30