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SORD-BILL Vs Conventional Options During Sacral Colpopexy for POP

NCT02479685 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-06-24

No results posted yet for this study

Summary

This prospective randomized pilot study is aimed to verify if the operative time of a standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment of POP could be further reduced using PKS BILL: bipolar laparoscopic loop (a laparoscopic loop using advanced bipolar energy) (Olympus Medical Systems Corp, Tokyo) and PKS PlasmaSORD (Solid Organ Removal Device) vs. conventional monopolar hook and conventional mechanic morcellator.

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

PKS BILL-PKS PlasmaSORD Versus Conventional surgical techniques

To verify if the operative time of a standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment of POP could be further reduced using PKS BILL: bipolar laparoscopic loop (a laparoscopic loop using advanced bipolar energy) (Olympus Medical Systems Corp, Tokyo) and PKS PlasmaSORD (Solid Organ Removal Device) vs. conventional monopolar hook and conventional mechanic morcellator.

Sponsors & Collaborators

  • Giuseppe Campagna

    collaborator UNKNOWN

  • Cristiano Rossitto

    collaborator UNKNOWN

  • Andrea Morciano

    collaborator UNKNOWN

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Giovanni Scambia, Professor · Catholic University of the Sacred Heart - Rome

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Italy

Study Locations

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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 NCT02479685 on ClinicalTrials.gov