Surgical Correction of Pelvic Organ Prolapse
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective:

      This prospective randomized trial evaluated outcomes of colposacropexy performed either by
      open or by conventional laparoscopic approach as therapy for uterovaginal prolapse. Surgical
      techniques, efficacy and overall results are compared.

      Methods:

      In this prospective study 40 consecutive patients with uro-genital prolapse are randomized to
      sacropexy: 20 by an open approach, 20 by a conventional laparoscopy approach. Anchorage is
      achieved in both groups by two polypropylene meshes.

      Check-ups were scheduled at 3, 6, 12 months and then yearly. Pre-operative patient
      characteristics, operative and post-operative events and follow-up results are recorded.
    

Detailed description: 
      Surgical technique In both open or laparoscopic approach the anterior vaginal wall is
      dissected from the bladder to expose a vaginal wall area of at least 3 x 5 cms where the mesh
      will be attached with four-five Polyglycolic 0 sutures. The procedure is repeated for the
      posterior vaginal wall, where the mesh will be attached with three-four Polyglycolic 0
      sutures.

      The sacral promontory surface is prepared and 1 or 2 non-reabsorbable 0.0 sutures are placed
      into the sacral periosteum about 2 cm below the promontory. A sub-peritoneal tunnel is
      created through which meshes are passed avoiding traction to the sacrum. The peritoneum is
      closed over the meshes.
    

Intervention name(s): Colposacropexy; Colposacropexy
Intervention type(s): Procedure; Procedure
Intervention description(s): In open approach the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area of at least 3 x 5 cms where the mesh will be attached with four-five Polyglycolic 0 sutures. The procedure is repeated for the posterior vaginal wall, where the mesh will be attached with three-four Polyglycolic 0 sutures. The sacral promontory surface is prepared and 1 or 2 non-reabsorbable 0.0 sutures are placed into the sacral periosteum about 2 cm below the promontory. A sub-peritoneal tunnel is created through which meshes are passed avoiding traction to the sacrum. The peritoneum is closed over the meshes.; In laparoscopic approach the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area of at least 3 x 5 cms where the mesh will be attached with four-five Polyglycolic 0 sutures. The procedure is repeated for the posterior vaginal wall, where the mesh will be attached with three-four Polyglycolic 0 sutures. The sacral promontory surface is prepared and 1 or 2 non-reabsorbable 0.0 sutures are placed into the sacral periosteum about 2 cm below the promontory. A sub-peritoneal tunnel is created through which meshes are passed avoiding traction to the sacrum. The peritoneum is closed over the meshes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pelvic organ prolapse; colposacropexy; surgery