Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05969067
• Other study ID #: 23-0124
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Females at least 18 years of age at the time of consent.

2. Able to understand and read English

3. Able and willing to provide written informed consent

4. Able to comply with the follow-up study protocol, per clinician judgment

5. Symptomatic POP (bulge or pressure) evidenced with vaginal prolapse with POP-Q measurement consistent with Stage II-IV.

6. RA SCP as desired surgical approach to correct apical prolapse

Exclusion Criteria:

1. Females who are pregnant, or intend to become pregnant during the study

2. Texas Department of Criminal Justice prisoners

3. A known history of sensitivity to propylene mesh

4. Prior prolapse repair surgery using mesh (abdominal, vaginal or rectal)

5. Active or chronic systemic infection including any pelvic infection, abscess

6. Has had history of primary pelvic organ cancer (uterine, ovarian, endometrial, cervical, bladder) or any cancer that is metastatic to the pelvis

7. Prior or current pelvic radiation, or chemotherapy.

8. Not a candidate for general anesthesia

9. History of systemic connective tissue or musculoskeletal disorders (scleroderma, SLE, Marfan's syndrome, Ehlers Danlos, polymyositis, Lambert Eaton syndrome etc)

10. History of neurologic condition affecting bladder function (multiple sclerosis, spinal cord injury, stroke with neurologic deficit)

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Tunneling Technique during RA SCP
As described in the intervention arm above
• Dissection Technique during RA SCP
As described in the intervention arm above

Locations

Country	Name	City	State
United States	University of Texas Medical Branch Galveston	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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