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Does examination with traction on the cervix pre-operatively increase the reproducibility of the degree of uterine prolapse intra-operatively

Does examination with traction on the cervix pre-operatively increase the reproducibility of the degree of uterine prolapse intra-operatively

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12611000141943
Enrollment
40
Registered
2011-02-07
Start date
2010-06-10
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Studies have shown that different conditions in which the POP-Q examination was performed and, variations in examination techniques eg. patient position, use of vaginal specula, retractors or tractors used, the type of straining used to develop the prolapse maximally, fullness of bladder and rectum, can affect the reproducibility of the measurements. Recent evidence suggests that intra-operative examination of prolapse under anaesthesia could be significantly different from pre-operative examination even if POP-Q system is used. Many pelvic surgeons use the moment directly before the start of the surgery, when the patient is already under anaesthesia to perform a final examination using traction and plan the exact operation. We propose that using the same examination technique ie. traction on the cervix, pre-operatively and intra-operatively under anaesthesia will increase the reproducibility of the POP-Q measurements obtained pre-operatively for uterine prolapse. The aims of the study are 2 fold. 1. To determine whether or not using traction on the cervix with an instrument pre-operatively to determine the severity of uterine prolapse reduces the difference between pre-operative and intra-operative POP-Q measurements of Point C 2. To determine the patient’s acceptability of using a traction instrument to assess uterine descent without anaesthetic

Interventions

- Prospective randomised observational study - Patients presenting for vaginal repair +/- vaginal hysterectomy will be asked to consent to the study (written consent) - Patients will be randomised to 2 arms 1. Pre-operative assessment in the pre-operative waiting bay with traction on the cervix (duration - 5 minutes) 2. Pre-operative assessment in the pre-operative waiting bay without traction on the cervix (duration 2 minutes) 3. Both groups of patients will have intra-operative assessment with

- Prospective randomised observational study - Patients presenting for vaginal repair +/- vaginal hysterectomy will be asked to consent to the study (written consent) - Patients will be randomised to 2 arms 1. Pre-operative assessment in the pre-operative waiting bay with traction on the cervix (duration - 5 minutes) 2. Pre-operative assessment in the pre-operative waiting bay without traction on the cervix (duration 2 minutes) 3. Both groups of patients will have intra-operative assessment with traction (duration 2 minutes of the entire operating time) - Instrument used to provide traction is a Vulsellum - Pain score will be collected in both groups of patients - In the group that are assessed with traction – 2 pain scores will be recorded (examination with and without traction) - Duration of observational study - 6 months

Sponsors

Fay CHAO
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

All patients presenting for vaginal repair +/- vaginal hysterectomy and are able to give consent

Exclusion criteria

Patients who have had a previous hysterectomy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026