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

NCT05668130 | Unknown DMC

• 1 other identifier: 394/079/080-IRC
• Study Type: interventional
• Target: 194
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Pelvic organ prolapse; Sacrospinous ligament fixation; Uterosacral ligament suspension

Outcome Measures

Primary Outcomes (2)

• Success rate of SSLF and USLS for apical suspension

  Success will be defined as absence of any of the following 1. Stage II or greater apical compartment prolapse 2. Awareness of bulge symptoms confirmed by affirmative response to question number 3 of PFDI-20. 3. Need of additional treatment for prolapse (ring pessary, repeat surgery)

  6 months after surgery

• Success rate of SSLF and USLS for apical suspension

  Success will be defined as absence of any of the following 1. Stage II or greater apical compartment prolapse 2. Awareness of bulge symptoms confirmed by affirmative response to question number 3 of PFDI-20. 3. Need of additional treatment for prolapse (ring pessary, repeat surgery)

  12 months after surgery

Secondary Outcomes (3)

• Perioperative outcomes

  1 week of surgery

• Complications

  during surgery, follow up at 6 month and 12 month

• postoperative PFDI- 20 score

  6 months and 12 months post surgery

Study Arms (2)

Sacrospinous Ligament Fixation Arm

EXPERIMENTAL

Women randomized to this arm will undergo sacrospinous ligament fixation for apical suspension procedure during pelvic organ prolapse surgery.

Procedure: Sacrospinous ligament fixation

Uterosacral Liganemt Suspension Arm

EXPERIMENTAL

Women randomized to this arm will undergo uterosacral ligament suspension for apical suspension procedure during pelvic organ prolapse surgery.

Procedure: Uterosacral Ligament Suspension

Interventions

Sacrospinous ligament fixation PROCEDURE

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.

Also known as: SSLF

Sacrospinous Ligament Fixation Arm

Uterosacral Ligament Suspension PROCEDURE

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.

Also known as: USLS

Uterosacral Liganemt Suspension Arm

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with stage 2-4 pelvic organ prolapse with or without uterus planned for vaginal surgery
• Women requiring concomitant surgical procedure for incontinence as needed

You may not qualify if:

• Women with pelvic organ prolapse planned for abdominal surgery
• Women undergoing uterus preserving surgery for pelvic organ prolapse
• Women undergoing Fothergill's repair/ Obliterative procedures
• Pregnant or postpartum women with prolapse
• Women refusing consent to participate in the study

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Tulasa Basnet, MD

  B.P. Koirala Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

• Mohan Chandra Regmi, MD

  B.P. Koirala Institute of Health Sciences

  STUDY CHAIR

• Baburam Dixit Thapa, MD

  B.P. Koirala Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

• Aparna Hegde, MD

  Grant Medical College, Mumbai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tulasa Basnet, MD

CONTACT

9779842158761; tulasabasnet29@gmail.com

Baburam Dixit Thapa, MD

CONTACT

9779842352481; baburamdixit@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 29, 2022
• Study Start: January 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share