The Clinical Outcome of TVM or LSC Mesh Suspension for POP

CompletedOBSERVATIONAL
Enrollment

466

Participants

Timeline

Start Date

January 1, 2012

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2018

Conditions
Pelvic Organ Prolapse
Interventions
PROCEDURE

LSC mesh suspension

Long mesh, a synthetic T-shaped mesh (Gynemsh, Ethicon, San Lorenzo, Puerto Rico), is delivered into the pelvic cavity. Bilateral mesh arms are extracted outside trocar wounds bilaterally to stabilize mesh position. The center piece is fixed to the cervix with 5mm ProTack screws (Covidien, New Haven, Connecticut). Fixation is strengthened with Stratafix 2-0 sutures (Ethicon, Norderstedt, Germany), followed by Tisseel fibrin sealant (Baxter, Deerfield, Illinois) for better hemostasis among surrounding tissues. An extraperitoneal tunnel is created along the left round ligament until reaching 2cm medial to the anterior superior iliac spine (ASIS). One arm of the long mesh is pulled out along the tunnel underneath round ligament and fixed with the fascia of oblique abdominis. The same procedure is repeated for the contralateral side. Bilateral round ligaments and the mesh arms are sutured continuously with Stratafix 2-0.

PROCEDURE

TVM

Transvaginal mesh kit is delivered into the pelvis via vagina route.

Trial Locations (1)

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

All Listed Sponsors
lead

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

NCT04139083 - The Clinical Outcome of TVM or LSC Mesh Suspension for POP | Biotech Hunter | Biotech Hunter