Surgical Techniques for Pelvic Organ Prolapse

Overseen By Tayseer Ishag, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Disqualifiers: Pregnancy, Cancer, Infection, others

Compensation: Varies

Number of Visits: 4

Duration: Intraoperative time

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two surgical methods, tunneling and dissection, used in robot-assisted surgery to fix a condition where pelvic organs drop from their normal position. It targets women with significant issues who need this surgery. The robot helps the surgeon perform the operation more accurately. The study aims to find out which method is better in terms of surgery time, recovery, and complications. Robot-assisted surgery for this condition has become increasingly popular due to its advantages in precision and ease of performing complex tasks compared to traditional methods.

Research Team

Gokhan Kilic, MD

Principal Investigator

UTMB

Eligibility Criteria

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.

Inclusion Criteria

I am choosing surgery to fix pelvic organ dropping.

Able to comply with the follow-up study protocol, per clinician judgment

I am a woman aged 18 or older.

Exclusion Criteria

I am not pregnant and do not plan to become pregnant during the study.

Texas Department of Criminal Justice prisoners

A known history of sensitivity to propylene mesh

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 8 weeks

1 visit (in-person)

Treatment

Participants undergo randomization to tunneling versus dissection technique during robotic assisted sacrocolpopexy

Intraoperative time

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

3 visits (in-person) at 2 weeks, 6 weeks, and 3 months postoperatively

Treatment Details

Interventions

• Dissection Technique during RA SCP
• Tunneling Technique during RA SCP

Trial Overview 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.

Participant Groups

Group I: Tunneling Technique Experimental Treatment 1 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 Technique Placebo Group 1 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.

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+