Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair

• Sponsor: Olympus Corporation of the Americas (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02258230
• Collaborator: International Urogynecology Associates (Other)
• Enrollment: 194
• Locations: 2
• Arms: 4
• Actual Duration (Months): 39
• Patients Per Site: 97
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

Compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse; Cystocele	Device: 3D mode of the 3D Laparoscopic Video System; Device: 2D mode of the 3D Laparoscopic Video System	N/A

Detailed Description

The purpose of this study is to compare operative times of laparoscopic sacral colpopexy (LSC) for the treatment of symptomatic vaginal vault prolapse as well as paravaginal repair (PVR) for symptomatic cystocele between two-dimensional and three-dimensional laparoscopic systems. Additionally this study will evaluate postoperative complications from surgeries performed using two-dimensional versus three-dimensional laparoscopic systems.

Study Design

• Study Type: Interventional
• Actual Enrollment: 194 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Laparoscopic 3D Versus 2D Sacral Colpopexy and Paravaginal Repair for Pelvic Organ Prolapse: a Comparison of Operative Times and Complications
• Actual Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2D mode LSC 2D mode of the 3D Laparoscopic Video System for the Laprascopic Sacral Colpopexy (LSC) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.	Device: 2D mode of the 3D Laparoscopic Video System; Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
Active Comparator: 3D mode LSC 3D mode of the 3D Laparoscopic Video System for the Laprascopic Sacral Colpopexy (LSC) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.	Device: 3D mode of the 3D Laparoscopic Video System; Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
Active Comparator: 2D mode PVR 2D mode of the 3D Laparoscopic Video System for the Paravaginal Repair (PVR) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.	Device: 2D mode of the 3D Laparoscopic Video System; Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
Active Comparator: 3D mode PVR 3D mode of the 3D Laparoscopic Video System for the Paravaginal Repair (PVR) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.	Device: 3D mode of the 3D Laparoscopic Video System; Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.

Outcome Measures

Primary Outcome Measures

1. Operative Times [Intraoperative]

   Operative times of laparoscopic sacral colpopexy and paravaginal repair procedures from the first part of dissection until closure of the peritoneum.

Secondary Outcome Measures

1. Complications [Intraoperative up to 6 weeks post procedure]

   Intraoperative complications will be recorded. Post operative complications will be reported for the first 6 weeks after the procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Symptomatic vaginal vault prolapse (stage 2 or greater point C-1 pelvic organ prolapse quantification [POP-Q] or grade 2 or greater Baden-Walker half way system) undergoing laparoscopic sacral colpopexy

And/Or

• Symptomatic cystocele (stage 2 or greater, point Aa or Ba > -1 POP-Q or grade 2 or greater Baden-Walker half way system) undergoing laparoscopic paravaginal repair

Exclusion Criteria:

• Age less than 18 years

• Inability to comprehend questionnaires

• Inability to give informed consent or to return for review

• Vaginal vault prolapse < stage 2

• Unable to undergo general anesthesia

• More than 5 previous laparotomies

• Prior sacral colpopexy or vaginal mesh prolapse procedure

• Prior surgery involving the retropubic space

• Vaginal length less than 6 cm

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beverly Hills Sunset Surgery Center	Los Angeles	California	United States	90069
2	Northside Hospital	Atlanta	Georgia	United States	30342

Sponsors and Collaborators

• Olympus Corporation of the Americas
• International Urogynecology Associates

Investigators

• Principal Investigator: Robert D Moore, DO, International Urogynecology Associates

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• International Urogynecology Associates' website

Publications

None provided.

• Responsible Party: Olympus Corporation of the Americas
• ClinicalTrials.gov Identifier: NCT02258230
• Other Study ID Numbers: 4859
• First Posted: Oct 7, 2014
• Last Update Posted: Apr 4, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Cystocele; Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Apr 4, 2018