Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy

NCT05969067 | Completed

• 1 other identifier: 23-0124
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapse; Sacrocolpopexy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• POP-Q exam

  Baseline, 6 weeks postoperatively and 12 weeks postoperatively

• Pelvic Floor Distress Inventory PFDI-20

  Baseline, 6 weeks postoperatively and 12 weeks postoperatively

• Pelvic Floor Impact Questionnaire PFIQ-7

  Baseline, 6 weeks postoperatively and 12 weeks postoperatively

• Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire PISQ-12

  Baseline, 6 weeks postoperatively and 12 weeks postoperatively

• Patient Global Impression of Improvement PGI-I

  Baseline, 6 weeks postoperatively and 12 weeks postoperatively

Study Arms (2)

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.

Procedure: Dissection Technique during RA SCP

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

Procedure: Tunneling Technique during RA SCP

Interventions

Tunneling Technique during RA SCP PROCEDURE

As described in the intervention arm above

Tunneling Technique

Dissection Technique during RA SCP PROCEDURE

As described in the intervention arm above

Dissection Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch Galveston

Galveston, Texas, 77554, United States

Location

Related Publications (12)

• 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.

  PMID: 24807341 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.

  PMID: 20966694 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.

  PMID: 27696355 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.

  PMID: 21979458 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.

  PMID: 21934441 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.

  PMID: 36418567 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.

  PMID: 30254863 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.

  PMID: 27344033 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.

  PMID: 30356342 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.

  PMID: 34506336 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.

  PMID: 31589864 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.

  PMID: 34028575 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gokhan Kilic, MD

  UTMB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 1, 2023
• Study Start: August 10, 2023
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)