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

Investigating pRophylactic utErosacral suspension AT Total lAparoscopiC Hysterectomy for patient outcomes and risk of prolapse occurrence - a randomised controlled trial (REATTACH)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000947707
Acronym
REATTACH
Enrollment
66
Registered
2022-07-05
Start date
2022-08-01
Completion date
2023-08-01
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

As per the recommendations from American Association of Gynaecologic Laparoscopists (AAGL) practice report, uterosacral ligament suspension may be performed during laparoscopic hysterectomy to reduce the risk of post-hysterectomy vaginal vault prolapse. Hence, ongoing research into the most effective method of preventing prolapse is warranted, this study aims to evaluate the effect of prophylactic uterosacral suspension at time of laparoscopic hysterectomy on reducing the risk of developing prolapse in the future.

Interventions

Consistent with our standard technique of hysterectomy, gynaecological surgeons commence the exposure of the uterosacrals by developing the medial pararectal space of Okabayashi. By this stage the lateral pararectal space of Latzko already has already been developed, ureters identified and lysed if necessary, and uterine vessels secured at the origin of the internal iliacs. The ureter is identified separating these two potential spaces, with the medial dissection carried to expose the uterosacra

Consistent with our standard technique of hysterectomy, gynaecological surgeons commence the exposure of the uterosacrals by developing the medial pararectal space of Okabayashi. By this stage the lateral pararectal space of Latzko already has already been developed, ureters identified and lysed if necessary, and uterine vessels secured at the origin of the internal iliacs. The ureter is identified separating these two potential spaces, with the medial dissection carried to expose the uterosacral through its entire extent, especially the junction of the upper and middle thirds. The inferior hypogastric nerve is identified and preserved whenever possible. If excision of deep infiltrating endometriotic deposits make the preservation of parts of the uterosacrals untenable, a proximal anchor towards the upper third of the ligament is chosen. A marking stitch may be appropriate in such cases for easy identification. The hysterectomy will then proceed per usual methods, including possible removal of associated adnexae. Uniformity of surgery will be ensured by a single surgical team performing all surgeries. For patients that are randomised to the high uterosacral suspension arm, following the hysterectomy ensuring adequate “pedicalisation” of the uterine vessels, the assistant places the uterosacral ligament ligament under stretch by lifting the vaginal angle. A 0 Prolene D7580 on a 26 mm CT2 needle is cut to 30 cm length (shorter if 2 separate suture packs used). The uterosacral ligament is plicated in an inside-out, outside-in fashion, always commencing within the medial rectal space with the ureter coursing laterally in view. This suture is then driven through the bulky attachment of the uterosacral to the peri-cervical ring. The next bite is taken lateral to the vaginal edge and medial to the uterine pedicle ensuring that the Prolene does not enter the vaginal mucosa throughout its entire course. This also prevents bunching or infolding of the vault edges which can make vault closure tricky. The suture carried anteriorly is then robustly anchored to the pubovesical fascia and then makes it way posteriorly past the anchor point to the uterosacral at the pericervical ring to incorporate a robust bite through the rectovaginal fascial attachment to this structure. Following this, the suture is tied intracorporeally with 5 squared knots. The procedure is then repeated on the other side. This will then be followed by vaginal closure of the vault is carried out using V-Loc 90 suture (Covidien, Dublin, Ireland) in 2 layers taking care to incorporate the pubovesical fascia and the rectovaginal fascia which is contiguous with the vaginal vault. The whole hysterectomy will take about 2 hours, the uterosacral suspension procedure will take approximately 10 more minutes. Technique will be documented in the operative notes recorded on electronic medical records (EMR)

Sponsors

Townsville University Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026