Outcomes:
In accordance with the design of the registry, the surgeons reported
complications and reoperations on a specific form during follow-up. To
ensure the completeness of the surgeon’s reports (for complications and
reoperations), we checked the data collected by each hospital’s data
department to link and monitor medical events after the index surgery
and surveyed the participating women.9 We analysed the
medical data collection as they were received. Queries to surgeons asked
them to confirm and detail any serious complications or reoperations
when data for these appeared to be missing.
We used the Clavien-Dindo classification to define serious
complications: cancellation of planned mesh repair due to intraoperative
injury or subsequent surgical intervention related to complication
(Grade III), life-threatening complication (Grade IV), or woman’s death
(Grade V).11Dindo D,
Demartines N, Clavien PA. Classification of surgical complications.
Ann Surg 2004;240:205-13. Minor adaptations of the classification
designated to describe specific POP-surgery complications were those
previously used in the PROSPERE
trial.22Lucot JP, Cosson
M, Bader G, Debodinance P, Akladios C, Salet-Lizée D, Delporte P,
Savary D, Ferry P, Deffieux X, Campagne-Loiseau S, de Tayrac R, Blanc
S, Fournet S, Wattiez A, Villet R, Ravit M, Jacquetin B, Fritel X,
Fauconnier A. Safety of Vaginal Mesh Surgery Versus Laparoscopic Mesh
Sacropexy for Cystocele Repair: Results of the Prosthetic Pelvic Floor
Repair Randomized Controlled Trial. Eur Urol 2018;74:167-76.
Conversion (for example, from laparoscopy to the vaginal route) due to
operative difficulties, such as adhesions, was not considered a
complication.33Twijnstra AR, Blikkendaal MD, van Zwet EW, Jansen
FW. Clinical relevance of conversion rate and its evaluation in
laparoscopic hysterectomy. J Minim Invasive Gynecol 2013;20:64-72.
Reoperation for prolapse recurrence was considered a failure but not a
complication. For each complication, the operative files of the index
surgery and subsequent procedures were reviewed by two of the authors
(XF and AC).