Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy

• Sponsor: Ain Shams University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04850365
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 34
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The aim of the current study is to compare abdominal sacral cervicopexy with vaginal sacrospinous cervicopexy in women with apical prolapse in terms of operative time, procedures safety and efficacy.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: Hysteropexy	N/A

Detailed Description

According to Cochrane group trials , abdominal approaches centered on sacral colpopexy is associated with lower risk of awareness of prolapse, repeat surgery for prolapse and dyspareunia than a variety of vaginal interventions. However, these trials weren't statistically significant and have focused on the effects in terms of anatomy and lacked the effect on functional outcomes, the quality of life, perioperative complications and the operative duration.

In this study, We hypothesize that prolonged operative duration will be associated with a greater risk of developing complications and so may guide us to a minimally invasive approach with better functional outcomes.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison Between Abdominal Sacral Hysteropexy and Vaginal Sacrospinous Hysteropexy for Management of Women With Apical Uterine Descent : a Randomized Clinical Trial
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Abdominal sacral hysteropexy The approach involves suspending the cervix to the anterior longitudinal ligament on the sacrum using permanent sutures or polypropylene mesh.	Procedure: Hysteropexy; Abdominal Sacral cervicopexy: The approach involves suspending the cervix to the anterior longitudinal ligament on the sacrum using permanent sutures or polypropylene mesh. Vaginal Sacrospinous cervicopexy: This transvaginal extraperitoneal technique involves suspending the sacrospinous ligament to the cervix using either a dissolvable or permanent suture. The suspension is performed in a unilateral fashion.
Other: Vaginal sacrospinous hysteropexy This transvaginal extraperitoneal technique involves suspending the sacrospinous ligament to the cervix using either a dissolvable or permanent suture. The suspension is performed in a unilateral fashion. The outcomes will be obtained as follow;	Procedure: Hysteropexy; Abdominal Sacral cervicopexy: The approach involves suspending the cervix to the anterior longitudinal ligament on the sacrum using permanent sutures or polypropylene mesh. Vaginal Sacrospinous cervicopexy: This transvaginal extraperitoneal technique involves suspending the sacrospinous ligament to the cervix using either a dissolvable or permanent suture. The suspension is performed in a unilateral fashion.

Outcome Measures

Primary Outcome Measures

1. Operative time [intraoperative]

   Operative time will be recorded starting from skin incision.

Secondary Outcome Measures

1. a_clinical effectiveness assessed by the pelvic organ prolapse quantification system (POP_Q). [From 6 months to 1 year follow up]

   The patients will be followed for recurrence of the symptoms and the degree of descent.

2. b_Number of participants with treatment_related adverse events as assessed by CTCAE v4.0 [From 6 months to 1 year follow up]

   It will be used to assess the safety and tolerability to the procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Symptomatic apical descent stage II or more.

2. Eligible for both surgical procedures

3. No uterine or cervical pathology.

4. Able to consent to participate in the trial.

Exclusion Criteria:

1. Women with contraindication to any surgical procedures.

2. Women with previous apical prolapse surgery.

3. One of the two surgical approaches is not feasible.

4. Women with concomitant surgical procedures apart from correction of the prolapse.

5. Women who prefer to have hysterectomy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams university	Cairo		Egypt	11511

Sponsors and Collaborators

• Ain Shams University

Investigators

• Principal Investigator: Asmaa Ragab Mady, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Hassan Mohamed Mostafa, Doctor, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04850365
• Other Study ID Numbers: Abdovagpexy
• First Posted: Apr 20, 2021
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Feb 15, 2022