Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy

Study Overview
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Brief Summary
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The purpose of this study is to compare operative time, patient reported outcomes, surgical complications, and surgical outcomes between the tunneling versus dissection technique during robotic assisted sacrocolpopexy (RA SCP).

Detailed Description
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Women with symptomatic, stage II to IV POP who plan RA SCP at UTMB Health will be approached to participate. Using the study protocol inclusion and exclusion criteria, patient's eligibility will be determined. All eligible subjects will provide the written informed consent before any research data is collected. All screening assessments will be completed at a preoperative, in-person, clinic visit, and within 60 days of surgery. The subject will then undergo randomization to tunneling versus dissection technique during RA SCP with the total sample size of 40 female subjects (20 per group). Concomitant procedures for POP or urinary incontinence are permitted and will be based upon the operating surgeons' standard clinical practice and best clinical judgement. Subsequently, the subject will have postoperative follow up at 2 weeks, 6 weeks and 3 months

Official Title
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Comparing Retroperitoneal Tunneling Versus Dissection Technique During Robotic Assisted Sacrocolpopexy for Pelvic Organ Prolapse

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Tunneling Technique during RA SCP
* Procedure: Dissection Technique during RA SCP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females at least 18 years of age at the time of consent. Able to understand and read English Able and willing to provide written informed consent Able to comply with the follow-up study protocol, per clinician judgment Symptomatic POP (bulge or pressure) evidenced with vaginal prolapse with POP-Q measurement consistent with Stage II-IV. RA SCP as desired surgical approach to correct apical prolapse Exclusion Criteria: Females who are pregnant, or intend to become pregnant during the study Texas Department of Criminal Justice prisoners A known history of sensitivity to propylene mesh Prior prolapse repair surgery using mesh (abdominal, vaginal or rectal) Active or chronic systemic infection including any pelvic infection, abscess Has had history of primary pelvic organ cancer (uterine, ovarian, endometrial, cervical, bladder) or any cancer that is metastatic to the pelvis Prior or current pelvic radiation, or chemotherapy. Not a candidate for general anesthesia History of systemic connective tissue or musculoskeletal disorders (scleroderma, SLE, Marfan's syndrome, Ehlers Danlos, polymyositis, Lambert Eaton syndrome etc) History of neurologic condition affecting bladder function (multiple sclerosis, spinal cord injury, stroke with neurologic deficit)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Dissection Technique<br>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. | Procedure: Dissection Technique during RA SCP<br>* As described in the intervention arm above<br>|
| Experimental: Tunneling Technique<br>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 | Procedure: Tunneling Technique during RA SCP<br>* As described in the intervention arm above<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time (minutes) | Operating time for dissection technique: includes dissection and suturing time. The dissection time starts when the robotic instruments are used to extend the retroperitoneal incision (created during the presacral space dissection) and ends when the extension reaches the posterior vaginal wall. The suturing time starts when the needle enters the peritoneum at the presacral space and ends when the suture is cut after the presacral space, retroperitoneal space and the peritoneum covering the mesh are completely re-approximated. Operating time for tunneling technique: includes tunneling and suturing time. The tunneling time starts when the robotic instruments are used to undermine the peritoneum and ends when the tunnel is completely created, reaching the posterior vaginal wall. The suturing time starts when the needle enters the peritoneum to close the presacral space and ends when the suture is cut after the peritoneum covering the mesh is completely re-approximated. | Intraoperative time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POP-Q exam | The POP-Q is staged by using the 9 measurements. The stage can range from good support (no organ descent) reported as a POP-Q stage 0 or I to a POP-Q score of IV (complete procidentia or vault eversion) | Baseline, 6 weeks postoperatively and 12 weeks postoperatively | 
| Pelvic Floor Distress Inventory PFDI-20 | The questionnaire is scored from 0-300. Higher scores indicate being worse (more distressing) | Baseline, 6 weeks postoperatively and 12 weeks postoperatively | 
| Pelvic Floor Impact Questionnaire PFIQ-7 | The questionnaire is scored from 0-300. Higher scores indicate being worse (more distressing) | Baseline, 6 weeks postoperatively and 12 weeks postoperatively | 
| Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire PISQ-12 | The total score of the PISQ-12 questionnaire ranges from 0 to 48. The higher the score is, the better the quality of sexual life. | Baseline, 6 weeks postoperatively and 12 weeks postoperatively | 
| Patient Global Impression of Improvement PGI-I | Report the patient's response using the response scale from 1-7 | Baseline, 6 weeks postoperatively and 12 weeks postoperatively | 
| Decision Regret Scale (DRS) | A five-item paper and pencil self-report measure that asks subjects to reflect on a particular decision and then rate each item on a Likert scale from 1 (strongly agree) to 5 (strongly disagree). Higher scores are worse. | 6 weeks postoperatively and 12 weeks postoperatively | 
| Satisfaction with Decision Scale (SDS) | Scoring consists of taking the mean of the 6 items (range 1 to 5) | 6 weeks postoperatively and 12 weeks postoperatively | 
| Clavien-Dindo classification for operative complication | The system is used to grade adverse events related to surgical procedures from 1 to 5. Higher grade indicates worse adverse event | 2 weeks, 6 weeks postoperatively and 12 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic organ prolapse, Sacrocolpopexy