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Completed

NCT Number: NCT05969067

Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Medical Branch Galveston

Galveston, Texas, 77554, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tunneling Technique during RA SCP

Procedure

As described in the intervention arm above

Dissection Technique during RA SCP

Procedure

As described in the intervention arm above

Primary outcomes

  1. Operative Time (minutes)

    Time frame: Intraoperative time

    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.

Secondary outcomes

  1. POP-Q exam

    Time frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively

    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)

  2. Pelvic Floor Distress Inventory PFDI-20

    Time frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively

    The questionnaire is scored from 0-300. Higher scores indicate being worse (more distressing)

  3. Pelvic Floor Impact Questionnaire PFIQ-7

    Time frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively

    The questionnaire is scored from 0-300. Higher scores indicate being worse (more distressing)

  4. Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire PISQ-12

    Time frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively

    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.

  5. Patient Global Impression of Improvement PGI-I

    Time frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively

    Report the patient's response using the response scale from 1-7

  6. Decision Regret Scale (DRS)

    Time frame: 6 weeks postoperatively and 12 weeks postoperatively

    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.

  7. Satisfaction with Decision Scale (SDS)

    Time frame: 6 weeks postoperatively and 12 weeks postoperatively

    Scoring consists of taking the mean of the 6 items (range 1 to 5)

  8. Clavien-Dindo classification for operative complication

    Time frame: 2 weeks, 6 weeks postoperatively and 12 weeks postoperatively

    The system is used to grade adverse events related to surgical procedures from 1 to 5. Higher grade indicates worse adverse event

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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