Clinical trial NCT04002375: Posterior Approach for Pectouteropexy
Official title: Posterior Approach for Pectouteropexy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Apical Prolapse
Keywords: pectouteropexy
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-06-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: POP-Q assesment
timeFrame: postoperative 1. day
Secondary outcomes:
measure: operation satisfaction
timeFrame: postoperative 1month
measure: pain scores
timeFrame: postoperative 1. day
Other outcomes:
Locations:
Study officials:
References: