NCT02479685

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

January 5, 2015

Last Update Submit

June 19, 2015

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Operative time for LPS subtotal hysterectomy and sacral colpopexy

    operative time will be calculated from the entrance in the abdominal cavity to the closure of the skin trocar accesses

    participants will be followed for the duration of hospital stay, , an expected average of 5 weeks

Secondary Outcomes (1)

  • incidence of intra- or postoperative complications estimated (blood loss, postoperative pain (evaluated by VAS), days of hospitalization and costs for the health care system).

    participants will be followed for the duration of hospital stay, , an expected average of 5 weeks

Study Arms (2)

SORD-BILL

EXPERIMENTAL

PKS BILL: bipolar laparoscopic loop (a laparoscopic loop using advanced bipolar energy) (Olympus Medical Systems Corp, Tokyo) and PKS PlasmaSORD (Solid Organ Removal Device) for subtotal hysterectomy and uterine morcellation, respectivelly, during sacral colpopexy for Pelvic Organ Prolapse.

Procedure: PKS BILL-PKS PlasmaSORD Versus Conventional surgical techniques

STANDARD

ACTIVE COMPARATOR

Conventional monopolar hook and conventional mechanic morcellator for subtotal hysterectomy and uterine morcellation, respectivelly, during sacral colpopexy for Pelvic Organ Prolapse.

Procedure: PKS BILL-PKS PlasmaSORD Versus Conventional surgical techniques

Interventions

PKS BILL-PKS PlasmaSORD Versus Conventional surgical techniquesPROCEDURE

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.

SORD-BILLSTANDARD

Eligibility Criteria

Age50 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For patients
  • Age ≤ 80 years
  • Patient's informed consent
  • American Society of Anesthesiologists: \< class III or IV
  • Physiologic, surgical or iatrogenic menopause.
  • No previous major abdominal surgical procedures
  • For diseases
  • POP-Q stage III/IV for anterior and/or apical compartment; stage \<III for posterior compartment.
  • No uterine cervix dysplasia or endometrial disorders.
  • No uterine size larger than conform 10 weeks gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Sacred Heart Rome,

Rome, Rome, 00100, Italy

Location

Related Publications (1)

  • Campagna G, Morciano A, Rossitto C, Panico G, Naldini A, Ercoli A, Cervigni M, Scambia G. A new approach to supracervical hysterectomy during laparoscopic sacral colpopexy for pelvic organ prolapse: A randomized clinical trial. Neurourol Urodyn. 2017 Mar;36(3):798-802. doi: 10.1002/nau.23030. Epub 2016 Apr 29.

    PMID: 27128776DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Giovanni Scambia, Professor

    Catholic University of the Sacred Heart - Rome

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 5, 2015

First Posted

June 24, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations

IT(1)