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Procedure
Surgical Techniques for Pelvic Organ Prolapse
N/A
Recruiting
Led By Gokhan Kilic, MD
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks, 6 weeks postoperatively and 12 weeks postoperatively
Awards & highlights
Study Summary
This trial will compare two methods of robotic-assisted surgery to repair pelvic floor problems. Results will measure time, patient outcomes, complications, and effectiveness.
Who is the study for?
This trial is for women over 18 with symptomatic pelvic organ prolapse (Stage II-IV) who choose robotic assisted sacrocolpopexy as their surgical treatment. Participants must understand English, consent to the study, and follow the protocol. Pregnant women, prisoners, those sensitive to propylene mesh or unfit for general anesthesia are excluded.Check my eligibility
What is being tested?
The study compares two techniques during robotic assisted sacrocolpopexy: tunneling versus dissection. It aims to evaluate differences in operative time, patient satisfaction, surgical complications, and overall success of the surgery between these methods.See study design
What are the potential side effects?
While not explicitly listed in your summary provided here, side effects may include typical risks associated with surgery such as infection risk at incision sites, pain or discomfort post-operation, bleeding complications or reactions to anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intraoperative time
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative time
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Operative Time (minutes)
Secondary outcome measures
Clavien-Dindo classification for operative complication
Decision Regret Scale (DRS)
POP-Q exam
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tunneling TechniqueExperimental Treatment1 Intervention
A retroperitoneal tunnel is created by undermining the peritoneum with the robotic scissors and/or needle driver which is placed in the peritoneal opening over the sacral promontory. The tunnel is created just medial to the right uterosacral ligament and toward the posterior vaginal wall by using forward pressure and a sweeping motion to create a space within the retroperitoneum
Group II: Dissection TechniquePlacebo Group1 Intervention
The peritoneum is incised superficially and opened longitudinally from the sacral promontory, downward to the posterior cul-de-sac and the posterior vaginal wall to create retroperitoneal space for the SCP mesh.
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Who is running the clinical trial?
The University of Texas Medical Branch, GalvestonLead Sponsor
243 Previous Clinical Trials
56,631 Total Patients Enrolled
1 Trials studying Pelvic Organ Prolapse
10 Patients Enrolled for Pelvic Organ Prolapse
Gokhan Kilic, MDPrincipal InvestigatorUTMB
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and do not plan to become pregnant during the study.I do not have any ongoing infections, including in the pelvic area.I have had radiation or chemotherapy targeting the pelvic area.I am choosing surgery to fix pelvic organ dropping.I cannot undergo surgery with general anesthesia.I have had surgery to fix prolapse with mesh before.I have had cancer in my pelvic area or cancer that has spread to my pelvis.I am a woman aged 18 or older.I have a neurological condition that affects my bladder function.I feel a bulge or pressure due to my pelvic organ prolapse, which is moderate to severe.I have a history of disorders like scleroderma or lupus.
Research Study Groups:
This trial has the following groups:- Group 1: Tunneling Technique
- Group 2: Dissection Technique
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor currently open to new participants?
"Clinicialtrials.gov states that this medical research is currently in the recruitment phase, firstly posted on the 1st of July 2023 and last edited on 28th of July that same year."
Answered by AI
How many participants are being recruited for this trial?
"Confirmed. Clinicaltrials.gov states that this research project is actively embracing participants, having initially been posted on July 1st 2023 and revised on July 28th 2023. 40 individuals are sought for enrollment at a single site."
Answered by AI
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