Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21+
SponsorNational Cheng-Kung University Hospital
About this trial
Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse.
Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, performed with expected safety and simplicity of surgery besides advantages including small wound incision and fast recovery in laparoscopic surgeries. This trial aim to discuss the therapeutic efficacy, long term safety, and adverse events of laparoscopic lateral uterine suspension and compare with the conventional transvaginal sacrospinous ligament fixation with native tissue repair.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
older than 21 years old.
uterine prolapse stage 2 at least, defined by C point distal to -1cm by POP-Q system.
patients willing to receive a uterine-preserving surgery for pelvic organ prolapse, and is suitable for anesthesia after evaluation.
patients who had or had not received conservative treatments for pelvic organ prolapse.
Disqualifiers
patient who had received a previous hysterectomy, or is planning on concomitant hysterectomy in the surgery for pelvic organ prolapse.
patient who had received a previous surgery for pelvic organ prolapse.
patient with history of adverse events following a synthetic mesh.
patients with chronic or acute pelvic pain.
Trial population
Patients with pelvic organ prolapse, predominantly apical prolapse, who had not received a previous surgical correction, and is willing to receive a uterine-preserving surgery for pelvic organ prolapse.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Laparoscopic uterine lateral suspension
Procedure/SurgeryLaparoscopic uterine lateral suspension done with four trocar sites. Fix a 1.5cm\*32cm mesh to uterus at anterior lower segment and bilateral round ligaments by non-absorbable sutures (Surgilon 2-0, Ethicon, Norderstedt, Germany), and to lateral abdominal fascia by non-absorbable sutures (Prolene 1-0, Ethicon, Norderstedt, Germany). Reperitonization done to avoid mesh exposure in peritoneal cavity. Concomitant anterior and posterior colporrhaphy may be performed.
Transvaginal sacrospinous fixation
Procedure/SurgeryTransvaginal sacrospinous fixation done by hand suturing uterus to right sacrospinous ligament with non-absorbable suture (Prolene 1-0, Ethicon, Norderstedt, Germany). Concomitant anterior and posterior colporrhaphy may be performed.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Laparoscopic uterine lateral suspension1 intervention
Group B: Transvaginal sacrospinous fixation1 intervention
Trial outcomes
Primary outcomes
1
Recurrence
Composite outcome of subjective and objective recurrence of uterine prolapse.
Time frame
5 yearsSecondary outcomes
1
Anatomical outcome
Comparison of total vaginal length (TVL), Ba, Bp points defined by POP-Q system.
Time frame
5 years2
Functional outcome
Comparison of urination and defecation functions by Pelvic floor disability index-20 (PFDI-20).
Time frame
5 years3
Sexual function outcome
Comparison of sexual function by Female Sexual Function Index (FSFI).
Time frame
5 years4
Urodynamic outcome
Comparison of post residual urine amount, uroflowmetry, and 1-hour pad test.
Time frame
6 monthsOther outcomes
1
Safety outcome
Surgery-related complications and mesh-related long term complications.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov