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Posterior Approach for Pectouteropexy

NCT04002375 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-06-28

No results posted yet for this study

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.

Conditions

  • Apical Prolapse

Interventions

OTHER

pectouteropexy

The surgical procedure was initiated after adhesiolysis had been performed by opening the peritoneal layer along the round ligament toward the pelvic side wall. Preparation started at the right external iliac vein and was performed in the medial and caudal direction. A segment of area approximately 3- 4 cm2 of the right lateral part of the iliopectineal ligament (Cooper ligament) adjacent to the insertion of the iliopsoas muscle was exposed.The peritoneum of the bladder was dissected, and the anterior parts of the distal uterus were prepared for mesh fixation. The uterus was elevated to the intended tension-free position using the transvaginal probe (POP-Q level 0-1). The mesh was fixed anteriorly to the cervix using four polyester permanent sutures (Ethibond Excel®; Ethicon). Finally, the mesh was covered with peritoneum using a continuous monofilament absorbable suture (Maxon™; Medtronic).

Sponsors & Collaborators

  • Dr. Lutfi Kirdar Kartal Training and Research Hospital

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2019-12-31
Completion
2020-02-27

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04002375 on ClinicalTrials.gov