Back to resultsRetroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy
Primary Purpose
Pelvic Organ Prolapse
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tunneling Technique during RA SCP
Dissection Technique during RA SCP
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic organ prolapse, Sacrocolpopexy
Eligibility Criteria
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)
Sites / Locations
- University of Texas Medical Branch GalvestonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Dissection Technique
Tunneling Technique
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Pelvic Floor Distress Inventory PFDI-20
The questionnaire is scored from 0-300. Higher scores indicate being worse (more distressing)
Pelvic Floor Impact Questionnaire PFIQ-7
The questionnaire is scored from 0-300. Higher scores indicate being worse (more distressing)
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.
Patient Global Impression of Improvement PGI-I
Report the patient's response using the response scale from 1-7
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.
Satisfaction with Decision Scale (SDS)
Scoring consists of taking the mean of the 6 items (range 1 to 5)
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
Full Information
NCT ID
NCT05969067
First Posted
July 7, 2023
Last Updated
August 17, 2023
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT05969067
Brief Title
Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy
Official Title
Comparing Retroperitoneal Tunneling Versus Dissection Technique During Robotic Assisted Sacrocolpopexy for Pelvic Organ Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2023 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Pelvic organ prolapse, Sacrocolpopexy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dissection Technique
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Tunneling Technique
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Tunneling Technique during RA SCP
Intervention Description
As described in the intervention arm above
Intervention Type
Procedure
Intervention Name(s)
Dissection Technique during RA SCP
Intervention Description
As described in the intervention arm above
Primary Outcome Measure Information:
Title
Operative Time (minutes)
Description
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.
Time Frame
Intraoperative time
Secondary Outcome Measure Information:
Title
POP-Q exam
Description
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)
Time Frame
Baseline, 6 weeks postoperatively and 12 weeks postoperatively
Title
Pelvic Floor Distress Inventory PFDI-20
Description
The questionnaire is scored from 0-300. Higher scores indicate being worse (more distressing)
Time Frame
Baseline, 6 weeks postoperatively and 12 weeks postoperatively
Title
Pelvic Floor Impact Questionnaire PFIQ-7
Description
The questionnaire is scored from 0-300. Higher scores indicate being worse (more distressing)
Time Frame
Baseline, 6 weeks postoperatively and 12 weeks postoperatively
Title
Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire PISQ-12
Description
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.
Time Frame
Baseline, 6 weeks postoperatively and 12 weeks postoperatively
Title
Patient Global Impression of Improvement PGI-I
Description
Report the patient's response using the response scale from 1-7
Time Frame
Baseline, 6 weeks postoperatively and 12 weeks postoperatively
Title
Decision Regret Scale (DRS)
Description
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.
Time Frame
6 weeks postoperatively and 12 weeks postoperatively
Title
Satisfaction with Decision Scale (SDS)
Description
Scoring consists of taking the mean of the 6 items (range 1 to 5)
Time Frame
6 weeks postoperatively and 12 weeks postoperatively
Title
Clavien-Dindo classification for operative complication
Description
The system is used to grade adverse events related to surgical procedures from 1 to 5. Higher grade indicates worse adverse event
Time Frame
2 weeks, 6 weeks postoperatively and 12 weeks postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trieu H Do, MD
Phone
8326327965
Email
trhdo@utmb.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tayseer Ishag, MD
Phone
8326327965
Email
tgishag@utmb.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gokhan Kilic, MD
Organizational Affiliation
UTMB
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77554
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trieu H Do, MD
Phone
832-632-7965
Email
trhdo@utmb.edu
First Name & Middle Initial & Last Name & Degree
Tayseer Ishag, MD
Phone
8326327965
Email
tgishag@utmb.edu
First Name & Middle Initial & Last Name & Degree
Gokhan Kilic, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD with other researchers
Citations:
PubMed Identifier
24807341
Citation
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Results Reference
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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.
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PubMed Identifier
27696355
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.
Results Reference
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PubMed Identifier
21979458
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.
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21934441
Citation
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.
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Citation
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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.
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Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy
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