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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dissection Technique | Placebo Comparator | 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. |
|
| Tunneling Technique | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tunneling Technique during RA SCP | Procedure | As described in the intervention arm above |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gokhan Kilic, MD | UTMB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch Galveston | Galveston | Texas | 77554 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24807341 | Background | Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286. | |
| 20966694 | Background | Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729. |
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There is no plan to share IPD with other researchers
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2023 | Jul 28, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Dissection Technique during RA SCP | Procedure | As described in the intervention arm above |
|
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 |
| 27696355 | Background | Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with apical vaginal prolapse. Cochrane Database Syst Rev. 2016 Oct 1;10(10):CD012376. doi: 10.1002/14651858.CD012376. |
| 21979458 | Background | Paraiso MFR, Jelovsek JE, Frick A, Chen CCG, Barber MD. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Nov;118(5):1005-1013. doi: 10.1097/AOG.0b013e318231537c. |
| 21934441 | Background | Erekson EA, Yip SO, Ciarleglio MM, Fried TR. Postoperative complications after gynecologic surgery. Obstet Gynecol. 2011 Oct;118(4):785-93. doi: 10.1097/AOG.0b013e31822dac5d. |
| 36418567 | Background | Kim EK, Applebaum JC, Kravitz ES, Hinkle SN, Koelper NC, Andy UU, Harvie HS. "Every minute counts": association between operative time and post-operative complications for patients undergoing minimally invasive sacrocolpopexy. Int Urogynecol J. 2023 Jan;34(1):263-270. doi: 10.1007/s00192-022-05412-1. Epub 2022 Nov 23. |
| 30254863 | Background | Hoshino K, Yoshimura K, Nishimura K, Hachisuga T. How to reduce the operative time of laparoscopic sacrocolpopexy? Gynecol Minim Invasive Ther. 2017 Jan-Mar;6(1):17-19. doi: 10.1016/j.gmit.2016.05.005. Epub 2016 Jul 5. |
| 27344033 | Background | Guan X, Ma Y, Gisseman J, Kleithermes C, Liu J. Robotic Single-Site Sacrocolpopexy Using Barbed Suture Anchoring and Peritoneal Tunneling Technique: Tips and Tricks. J Minim Invasive Gynecol. 2017 Jan 1;24(1):12-13. doi: 10.1016/j.jmig.2016.06.012. Epub 2016 Jun 23. |
| 30356342 | Background | Liu J, Bardawil E, Zurawin RK, Wu J, Fu H, Orejuela F, Guan X. Robotic Single-Site Sacrocolpopexy with Retroperitoneal Tunneling. JSLS. 2018 Jul-Sep;22(3):e2018.00009. doi: 10.4293/JSLS.2018.00009. |
| 34506336 | Background | Pushkar DY, Kasyan GR, Popov AA. Robotic sacrocolpopexy in pelvic organ prolapse: a review of current literature. Curr Opin Urol. 2021 Nov 1;31(6):531-536. doi: 10.1097/MOU.0000000000000932. |
| 31589864 | Background | Matanes E, Boulus S, Lauterbach R, Amit A, Weiner Z, Lowenstein L. Robotic laparoendoscopic single-site compared with robotic multi-port sacrocolpopexy for apical compartment prolapse. Am J Obstet Gynecol. 2020 Apr;222(4):358.e1-358.e11. doi: 10.1016/j.ajog.2019.09.048. Epub 2019 Oct 4. |
| 34028575 | Background | Halder GE, White AB, Brown HW, Caldwell L, Wright ML, Giles DL, Heisler CA, Bilagi D, Rogers RG. A telehealth intervention to increase patient preparedness for surgery: a randomized trial. Int Urogynecol J. 2022 Jan;33(1):85-93. doi: 10.1007/s00192-021-04831-w. Epub 2021 May 24. |
| 41136725 | Derived | Do T, Halder G, Jackson E, Yaklic J, Kilic G. Tunneling Versus Dissection Technique During Robotics-Assisted Sacrocolpopexy: A Randomized Clinical Trial. Int Urogynecol J. 2026 Jan;37(1):235-242. doi: 10.1007/s00192-025-06316-6. Epub 2025 Oct 24. |