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NCT Number: NCT05586984

Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension

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.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

National Cheng Kung University Hospital

Tainan, Taiwan

Location status: Recruiting

Location contact

Yu Fang Huang, MD

CONTACT

[email protected]

886-6-2353535 ext. 3104

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic uterine lateral suspension

Procedure

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 fixation

Procedure

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.

Primary outcomes

  1. Recurrence

    Time frame: 5 years

    Composite outcome of subjective and objective recurrence of uterine prolapse.

Secondary outcomes

  1. Anatomical outcome

    Time frame: 5 years

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

  2. Functional outcome

    Time frame: 5 years

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

  3. Sexual function outcome

    Time frame: 5 years

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

  4. Urodynamic outcome

    Time frame: 6 months

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

Other outcomes

  1. Safety outcome

    Time frame: 5 years

    Surgery-related complications and mesh-related long term complications.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Fang Huang, MD

CONTACT

[email protected]

886-6-2353535 ext. 3104

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

A Prospective, Observational Trial of Transvaginal Uterine Suspension With the New Minimally Invasive Uterine Suspension

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Oct 19, 2022
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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