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Comparison of Sacrospinous Ligament Fixation and Uterosacral Ligament Suspension for Apical Prolapse Surgery: A Randomized Clinical Trial

NCT05668130 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2023-01-04

No results posted yet for this study

Summary

the main aim of this study is to study the anatomical and functional outcomes of two vaginal apical fixation procedures; sacrospinous ligament fixation and uterosacral ligament suspension, for pelvic organ prolapse surgery.

The participants will be randomized to either of the surgical procedure and will be followed up for one year to study the outcome.

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

Sacrospinous ligament fixation

Women with stage II or higher pelvic organ prolapse with apical compartment involvement planned for surgical management will be randomised to either sacrospinous ligament fixation arm or uterosacral ligament suspension arm. those raandomized to sacrospinous ligament fixation arm will undergo unilateral (right) sided sacrospinous ligament fixation of apex as a part of pelvic organ prolapse surgery.

PROCEDURE

Uterosacral Ligament Suspension

Similarly women randomised to uterosacral ligament suspension arm will undergo modified high uterosacral ligament suspension of apex. Both arms will be followed up in 6 months and 12 months for anatomical and functional outcome.

Sponsors & Collaborators

  • B.P. Koirala Institute of Health Sciences

    lead OTHER

Principal Investigators

  • Tulasa Basnet, MD · B.P. Koirala Institute of Health Sciences

  • Mohan Chandra Regmi, MD · B.P. Koirala Institute of Health Sciences

  • Baburam Dixit Thapa, MD · B.P. Koirala Institute of Health Sciences

  • Aparna Hegde, MD · Grant Medical College, Mumbai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2024-07-31
Completion
2025-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05668130 on ClinicalTrials.gov