Anchor placement and subsequent movement in a mesh kit with self‐fixating tips: 6‐month follow‐up of a prospective cohort
Bibliographic record
Abstract
OBJECTIVE: To describe the initial placement of Elevate single-incision mesh kit device tips relative to the sacrospinous ligament, and to measure tip movement over a 6-month period from initial placement. DESIGN: Prospective cohort. SETTING: Tertiary care urogynaecology centre in Calgary, Canada. POPULATION: Women electing for surgical management of anterior vaginal wall prolapse. METHODS: Ten women underwent anterior prolapse repair using the Elevate single-incision mesh kit with a metallic fiducial marker attached to the tips of the surgical device. Women were imaged by magnetic resonance imaging (MRI) within 48 hours of surgery, and again 6 months later to investigate the position of the device tips and change ≥4 mm over the 6-month postoperative period. MAIN OUTCOME MEASURE(S): Position of self-fixating tips within 48 hours of surgery, and at six months post-operative. RESULTS: Anchor insertion was directly into the sacrospinous ligament in 10 of 20 insertion points (50%, 95% CI 27-73%). Movement was most often noted in the cranial-caudal direction: a change in location of ≥4 mm was observed for 8/20 anchors (40%, 95% CI 19-64%). Cranial-caudal movement was observed less frequently among sacrospinous anchors than among anchors inserted into other pelvic structures (1/10 versus 7/10, P = 0.020, difference in proportion -60%, 95% CI -94 to -26%). PFDI-20 scores improved statistically significantly by 6 months (P = 0.008, mean change -62.9%, 95% CI -105.1 to -20.7%), but PFIQ-7 scores did not change statistically significantly over the same time period (P = 0.523, mean change -12.4%, 95% CI -54.5 to 29.8%). CONCLUSIONS: The novel self-fixating anchoring tips of this single-incision mesh kit do not reliably anchor into the sacrospinous ligament. The tips have been shown to move with time, although not all cases of anchor movement were associated with recurrent prolapse.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.001 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".