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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
As described in the intervention arm above
As described in the intervention arm above
University of Texas Medical Branch Galveston
Galveston, Texas, United States
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.
Time frame: Intraoperative time
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)
Time frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
Pelvic Floor Distress Inventory PFDI-20
The questionnaire is scored from 0-300. Higher scores indicate being worse (more distressing)
Time frame: 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)
Time frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire PISQ-12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Patient Global Impression of Improvement PGI-I
Report the patient's response using the response scale from 1-7
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 2 weeks, 6 weeks postoperatively and 12 weeks postoperatively