Posterior Approach for Pectouteropexy

Pectouteropexy surgery has lower complication rates compared to other sling operations. Sacrocolpopexy is another common procedure for hanging the uterus. Small bowel obstruction, ileus or defecation problems are observed in percentages ranging from 0.1 to 5%. Mesh placed between sacrum and vagina often causes narrowing of the pelvis, adhesions may occur and traumas may occur in hypogastic nerves. However, presacral bleeding, which is the most feared complication of these operations, is a rare but life-threatening condition. In pectouteropexy, it is located away from the bladder, intestine and hypogastric vessels by placing the iliopectineal ligament laterally and eliminates the risk of presacral hemorrhage.

In pectouteropexy surgery, the mesh is placed anterior to the cervix. The points emphasized in the criticisms about this technique, inadequate support of the posterior compartment mesh placed in anterior in a future pregnancy is a possible cesarean section and the negative effects on the delivery process.

Therefore, a new technique of pectouteropexy surgery to the posterior of the cervix instead of the anterior cervix of the cervix, the sacrouterine ligament to reduce the complications that may occur due to this procedure and this study was planned to increase the effectiveness.

Study Overview

• Status: Unknown
• Conditions: Apical Prolapse
• Intervention / Treatment: Other: pectouteropexy

Detailed Description

The study was planned prospectively. The research is planned to be conducted between 30.06.2019 and 30.12.2019. Study Kartal İstanbul Prof. Dr. Lütfi Kırdar Training and Research Hospital Department of Obstetrics and Gynecology. Under the responsibility of Prof. Dr. Ahmet Kale, it will be conducted by Kazibe Koyuncu. The study was planned as a pilot study since it was planned to investigate the results of performing the surgical method with the posterior approach instead of the anterior approach and it was calculated that the inclusion of 20 patients would be sufficient. It is planned to include 20 patients between 30-60 years of age who applied to hospital with prolapse complaint and completed fertility request. Patients' symptoms and physical examinations will be recorded in accordance with international standards and questionnaires will be applied to the files in order to make objective evaluation before and after surgery. Pre-and post-operative POP-Q classifications will be recorded in the files, PFDI-20 questionnaire evaluating the severity of prolapse before and after the surgery, and PGI questionnaire evaluating postoperative satisfaction. In the pectouteropexy operation we applied to the patients, the support of the uterus posterior was insufficient in the sling fixation with mesh suture to the anterior and iliopectineal ligaments of the uterine cervix. We aimed to increase the efficiency of the operation by hanging the uterine cervix posterolaterale to the iliopectineal ligament with the anterior uterine cervix in order to get better results with this method, which can be applied more safely and easily than the other sling methods. Consent form is attached.

There are validity-reliability studies of the questionnaires to be used in Turkish.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: kazibe koyuncu, M.D.; Phone Number: 00905053728124; Email: kazibekkoyuncu@gmail.com
• Study Contact Backup: Name: eda sayar, M.D.; Phone Number: 0090 5362141874; Email: edasyr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 1. Being between 30-60 years of age 2. To be diagnosed with at least Stage 2 apical prolapse 3. To have completed fertility 4. To be treated with pectouteropexy for the prolapse

Exclusion Criteria:

• 1. Having had previous prolapse surgery 2. To have connective tissue diseases 3. Inable to cooperate

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POP-Q assesment	pelvic organ prolapse quantification system assessment, does not have any maximum or minimum value, it is scored according to the visualization and is used to assess the difference of prolapse objectively	postoperative 1. day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operation satisfaction	operation satisfaction will be assessed via patient global impression of improvement, it is scaled one to seven, one is related to be satisfied with the result of operation and seven is related to not satisfied from the operation results	postoperative 1month
pain scores	pain scores will be assessed via visual analog scale questionnaire, it is scaled one to ten, one is related to have a little pain and 10 is related to have a lot of pain	postoperative 1. day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): June 30, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): February 27, 2020

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): June 28, 2019
• Last Update Submitted That Met QC Criteria: June 27, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: pectouteropexy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: KK201906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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