Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension

National Cheng-Kung University Hospital90 enrolled

Overview

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.

Pelvic organ prolapse can be treated either conservatively or surgically. Patients who are unsatisfied with conservative treatment or with severe symptoms often seek for surgical intervention. Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse. Laparoscopic sacrohysteropexy is the current trend for laparoscopic surgery, with small incisional wound, fast recovery, and low recurrence rate as advantages. However, laparoscopic sacrohysteropexy is often regarded as time consuming and ous sometimes hazard given the complexity of surgical technique and the anatomy of the presacral region. Few cases with severe complications such as vascular injuries, sacral nerve root injuries, and diskitis had been reported with laparoscopic sacrohysteropexy in previous studies. Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, is therefore proposed in our study. The most significant benefits of this novel approach include 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 of laparoscopic lateral uterine suspension and compare with the transvaginal sacrospinous ligament fixation with native tissue repair. Other results include safety and adverse events of laparoscopic lateral uterine suspension in long term follow up.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pelvic Organ Prolapse

Interventions

Laparoscopic uterine lateral suspensionPROCEDURE

Laparoscopic 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 fixationPROCEDURE

Transvaginal 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.

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. * patients able and willing to finish the questionnaire evaluation. Exclusion Criteria: * 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. * patients who had received abdominal or pelvic irradiation. * patients who cannot receive either surgery due to comorbidity. * patients pregnant or with future plan of pregnancy. * patients with vaginal length less than 5cm.

Outcomes

Primary Outcomes

Recurrence

Composite outcome of subjective and objective recurrence of uterine prolapse.

Time frame: 5 years

Secondary Outcomes

Anatomical outcome

Comparison of total vaginal length (TVL), Ba, Bp points defined by POP-Q system.

Time frame: 5 years

Functional outcome

Comparison of urination and defecation functions by Pelvic floor disability index-20 (PFDI-20).

Time frame: 5 years

Sexual function outcome

Comparison of sexual function by Female Sexual Function Index (FSFI).

Time frame: 5 years

Urodynamic outcome

Comparison of post residual urine amount, uroflowmetry, and 1-hour pad test.

Time frame: 6 months

Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts