NCT04002375|UnknownPhase 4DMC
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Sponsor study identifier
interventional
20
0 countries
N/A
Study Start
June 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 27, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 27, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 25, 2019
Actual (reported)June 28, 2019
Actual (reported)June 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 27, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
operation satisfaction
postoperative 1month
pain scores
postoperative 1. day
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).
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First Submitted
June 25, 2019
First Posted
June 28, 2019
Study Start
June 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2019
Concordance of Pelvic Organ Mobility Measurements Between the Finite Element Model and the Dynamic Pelvic Floor MRI in Patients Undergoing a Sacrospinofixation Surgery
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 27, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 28, 2019
Record last verified: 2019-06
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Source: ClinicalTrials.gov.
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