What side effects are associated with this type of intervention?

The most common treatments for Pelvic Organ Prolapse (POP) include surgical methods like sacrocolpopexy and native tissue transvaginal repair, as well as non-surgical options like pessaries. Sacrocolpopexy, particularly when performed robotically, is associated with a lower risk of acute postoperative urinary retention, fewer urinary tract infections, and fewer emergency department visits compared to native tissue transvaginal repair. However, both surgical methods can lead to complications such as voiding dysfunction and the need for repeat surgeries. Pessaries, while less invasive, may cause vaginal irritation, discharge, and ulceration. Each treatment option has its own risk profile, and the choice of treatment should be tailored to the patient's specific condition and needs.

What prior FDA approvals exist?

The FDA has approved several surgical mesh products for the treatment of Pelvic Organ Prolapse (POP), which are often used in procedures like sacrocolpopexy. These mesh products are designed to provide additional support to the weakened pelvic floor structures. However, due to complications such as mesh erosion and pain, the FDA has re-evaluated the safety and efficacy of these products. In 2019, the FDA ordered the halt of sales of transvaginal mesh products for POP repair. For robotic-assisted sacrocolpopexy (RA SCP), which involves either tunneling or dissection techniques, the use of synthetic mesh is still a common practice, but it is performed abdominally rather than transvaginally, which has shown to have fewer complications.

What other types of research exist?

Promising, novel alternatives to the Tunneling vs. Dissection Technique in RA SCP for pelvic organ prolapse patients include: 1) Enhanced robotic-assisted techniques with improved tactile feedback and precision, 2) Use of advanced imaging technologies for better visualization and accuracy during surgery, and 3) Implementation of enhanced recovery after surgery (ERAS) protocols to improve postoperative outcomes and reduce recovery time.

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Procedure

Surgical Techniques for Pelvic Organ Prolapse

N/A

Waitlist Available

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

Summary

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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative time for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Operative Time (minutes)

Secondary study objectives

Clavien-Dindo classification for operative complication

Decision Regret Scale (DRS)

POP-Q exam

+5 more

Trial 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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pelvic Organ Prolapse (POP) is commonly treated with surgical interventions aimed at restoring the normal anatomical position of the pelvic organs. Robotic Assisted Sacrocolpopexy (RA SCP) is a minimally invasive surgical technique that uses a mesh to support the vaginal vault or cervix by attaching it to the sacrum. The Tunneling and Dissection techniques are two methods used during RA SCP to create a pathway for the mesh. The Tunneling technique involves creating a tunnel through the retroperitoneal space to place the mesh, while the Dissection technique involves dissecting the tissue layers to achieve the same goal. These methods are crucial for POP patients as they aim to provide durable support, reduce recurrence rates, and minimize complications, thereby improving the quality of life and functional outcomes.