Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 3:02 AM
Ignite Modification Date: 2025-12-25 @ 3:02 AM
NCT ID: NCT01535833
Brief Summary: The investigators scientific aims are to determine the benefits associated with the use of robotic assisted laparoscopic sacrocolpopexy surgery on women with prolapse, to define how the benefits impact the patient, physician and the institution, and to determine the complications associated with the use of the robot. This will be a prospective cohort following 100 patients for a 24 month period.
Detailed Description: The investigators scientific aims are to determine the benefits associated with the use of robotic assisted laparoscopic sacrocolpopexy surgery on women with prolapse, to define how the benefits impact the patient, physician and the institution, and to determine the complications associated with the use of the robot. This will be a prospective cohort following 100 patients for a 24 month period. The investigators primary outcomes will be: * Surgical time: Key portion of procedure will be assessed along with total time for completion * Learning curve: Will be assessed using surgical times, VAS of camera skills, surgical skills involving tissue handling and movements and overall performance by surgeon, assistant and blind reviewer * Length of hospitalization: measured by days in hopsital The investigators secondary outcomes will be: * Pre-operative and postoperative Pelvic Organ Prolapse-Quantification (POP-Q) at 6 week, 6, 12, and 24 months. * Pelvic Floor Distress Inventory-Short Form 20 Questionnaire (PFDI-20) * Mesh erosion, * Estimated blood loss, * Complications (bowel or bladder injury) and, * Wound infection, * Patient Global Impressions of Improvement * Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).
Study: NCT01535833
Study Brief:
Protocol Section: NCT01535833