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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two surgical techniques for treating pelvic organ prolapse, a condition where pelvic organs fall out of place, causing discomfort. Researchers will examine the duration of each surgery, patient satisfaction with the results, and any complications that might arise. The study will test the tunneling technique against the dissection technique during robotic-assisted sacrocolpopexy (RA SCP) surgery. Women who have experienced noticeable symptoms like bulging or pressure due to prolapse and are considering robotic surgery as a treatment option might be a good fit for this trial.

As an unphased trial, this study offers participants the chance to contribute to valuable research that could improve surgical outcomes for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these surgical techniques are safe for pelvic organ prolapse?

Earlier studies have shown that the tunneling technique used in robotic-assisted sacrocolpopexy (RA SCP) is well-tolerated by patients. Research suggests that this method might shorten surgery time without increasing the risk of complications. These findings indicate that the technique is generally safe, with no significant reports of serious side effects based on available data.

Specific safety information for the dissection technique is not available in the provided sources. However, its use as a comparison in this study often implies it is a standard approach with a likely known safety record.

Overall, both techniques in this study appear to be safe options for patients undergoing surgery for pelvic organ prolapse. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative surgical techniques for treating pelvic organ prolapse. The Tunneling Technique is unique because it involves creating a retroperitoneal tunnel using robotic tools, allowing for a potentially more precise and less invasive approach. Unlike traditional methods that involve more extensive dissection, this technique might reduce tissue damage and recovery time. By comparing it with the Dissection Technique, which involves a more conventional opening of the peritoneum, researchers hope to find out if these new methods can improve surgical outcomes and patient recovery.

What evidence suggests that these surgical techniques are effective for pelvic organ prolapse?

This trial will compare two surgical techniques for pelvic organ prolapse: the tunneling technique and the dissection technique during robotic-assisted sacrocolpopexy (RA SCP). Studies have shown that both techniques lead to similar improvements in pelvic health and quality of life. However, the tunneling technique, which participants in one arm of this trial may receive, offers one clear advantage: it requires less time to perform than the dissection method. As a result, patients spend less time in surgery. Both methods have similar rates of complications, indicating they are equally safe. While both techniques are effective, the tunneling method may make the surgery quicker. ^{1 2 3 4 6}

Who Is on the Research Team?

Gokhan Kilic, MD

Principal Investigator

UTMB

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41136725/

Tunneling Versus Dissection Technique During Robotics ... During RA SCP, operative time is longer when using retroperitoneal dissection than when using the tunneling technique.

2. link.springer.com link.springer.com/article/10.1007/s00192-025-06354-0

Tunneling Versus Dissection Technique During Robotics ... Both techniques achieved comparable improvements in anatomical outcomes, quality-of-life scores, and overall complication rates at 12 weeks ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12039164/

Comparing Surgical Outcomes in Laparoscopic Sacral ... The tunneling group (n = 14) demonstrated significantly shorter surgical times than the nontunneling (n = 18) group (60.79 ± 22.35 minutes vs ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02856217

Impact of Tunneling During Minimally Invasive ... In this arm of the study which is Peritoneal non-tunneling group in SCP, standard minimal invasive sacrocolpopexy procedure will be performed. Placement of mesh ...

5. researchgate.net researchgate.net/publication/396992680_Commentary_Tunneling_Versus_Dissection_Technique_During_Robotics-Assisted_Sacrocolpopexy_A_Randomized_Clinical_Trial

Tunneling Versus Dissection Technique During Robotics ... The retroperitoneal tunneling technique during sacrocolpopexy (SCP) has been suggested as being associated with a shorter ope rative time, ...

6. trial.medpath.com trial.medpath.com/clinical-trial/8efcfc7942d5644b/comparing-retroperitoneal-tunneling-dissection-technique-robotic-assisted-sacrocolpopexy-pelvic-organ

Retroperitoneal Tunneling Versus Dissection Technique ... The purpose of this study is to compare operative time, patient reported outcomes, surgical complications, and surgical outcomes between the tunneling versus ...