pRophylactic utErosacral suspension AT Total lAparoscopiC Hysterectomy and the risk of prolapse occurrence – a randomised controlled trial (REATTACH)

Not Applicable

• Conditions: terovaginal prolapse; Uterovaginal prolapse; Surgery - Other surgery; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12622000947707
• Lead Sponsor: Townsville University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-05
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

•Patients must be 18 years of age or older
•Patients must be able to provide informed consent
•Preoperative inclusion criteria include: C point not past the hymenal remnant, i.e. C point at point 0 at Valsalva
•Patients with no prolapse symptoms
•A Pelvic ultrasound scan (USS) in the last 6 months from booking of procedure to show that size of uterus is less than or equal to 300cc

Exclusion Criteria

•Women undergoing a total laparoscopic hysterectomy for malignancy
•Women with a history of pre-existing pelvic organ prolapse, patients with cervical apical descent past the hymen, grade 2 uterocervical pelvic organ prolapse will be excluded
•Women with serious medical conditions who are unable to perform a Valsalva manoeuvre
•Non-English-speaking patients (unless access to a qualified interpreter is available during the full duration of the study)
•Size of uterus on ultrasound scan greater than 300cc
•Age greater than 75 years old
•BMI greater than 45
•Pathology obliterating the pouch of Douglas
•Stage 4 endometriosis
•Anticipated geographic relocation within the first 12 months following surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Quantitative C point; <br>(C point is part of POP Q (pelvic organ prolapse quantification) assessment, which is the distance the cervix (or vault in a post hysterectomy setting) from the hymenal remnant). Data collected at different time points will be stored on a data collection spreadsheet stored on REDCap at Townsville University Hospital. REDCap (Research Electronic Data capture) is a secure, web-based software platform about the study.<br>[post surgery, 6 and 12 months (primary endpoint)];- Change in sexual function assessed using the PISQ-12 questionnaire;<br><br>[Baseline (pre-surgery) and 3 months post surgery];- Change in symptom distress from pelvic floor dysfunction assessed using the PFDI - 20;<br><br>[Baseline (pre-surgery) and 3 months post surgery]

Secondary Outcome Measures

Name	Time	Method
length of operative time through an audit of operative notes by obtaining surgery start and end times<br><br>[immediately post-surgery];presence of complications such as rates of urinary retention, urinary tract infection, bladder injury, paraesthesia. This data will be obtained through an audit of operative notes and will be asked to patients in the phonemail for their routine 3 months followup in going through their questionnaire[3 months post surgery]