Serious complications and reoperations for recurrence after anterior sacropexy and double mesh sacropexy in the absence of rectocele: analysis of 1966 patients in the French VIGI-MESH register

Armengaud C1, Drioueche H1, Campagne Loiseau S2, Wagner L3, Bosset P4, Boisrame T5, Cosson M6, Deffieux X7, Panel L8, Ferry P9, Bresson L10, Thubert T11, Pizzoferrato A12, Coret M13, Lucot J14, Lamblin G15, Bautrant E16, Salet-Lizee D17, Ramanah R18, Koebele A19, Benabida S20, Carlier-Guérin C21, Fauconnier A22, Fritel X23

Research Type

Clinical

Abstract Category

Female Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction

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Abstract 11
Female Stress Urinary Incontinence
Scientific Podium Short Oral Session 1
Wednesday 23rd October 2024
09:45 - 09:52
N104
Female Pelvic Organ Prolapse Pelvic Floor Surgery Prospective Study
1. Centre Hospitalier Intercommunal Poissy-Saint Germain, 2. Service de Gynécologie-Obstétrique, CHU Estaing, Clermont-Ferrand, 3. Service de Gynécologie-Obstétrique, CHU de Nîmes, 4. Service d'urologie, Hôpital Foch, Suresnes, 5. Service de Gynécologie-Obstétrique, CHU de Strasbourg, 6. Service de Gynécologie-Obstétrique, CHU de Lille, 7. Service de Gynécologie-Obstétrique, APHP Antoine-Béclère, 8. Service de Gynécologie, Clinique Beau-Soleil, Montpellier, 9. Service de Gynécologie-Obstétrique, CH de La Rochelle, 10. Service d'urologie, Polyclinique d'Hénin Beaumont, 11. Service de Gynécologie, CHU de Nantes, 12. Service de Gynécologie-Obstétrique et Médecine de la Reproduction, CHU de Poitiers, 13. Service de Gynécologie-Obstétrique, CHU de Bordeaux, 14. Service de Gynécologie-Obstétrique, Hôpital Saint-Vincent-de-Paul, Lille, 15. Service de Gynécologie-Obstétrique, Hôpital Femme-Mère-Enfant, Hospices civils de Lyon, 16. Centre Gynécologique l'Avancée, Aix en Provence, 17. Groupe Hospitalier Diaconesses-Croix-Saint-Simon, Service de gynécologie, 18. Pôle mère-femme, CHRU de Besançon, 19. Service de Gynécologie, Maternité régionale universitaire, Nancy, 20. Centre d'urologie UROVAR, Hyères, Toulon, 21. Service de Gynécologie, CH de Châtellerault, 22. Service de Gynécologie-Obstétrique, CHI Poissy St Germain, 23. Service de Gynécologie-Obstétrique et Médecine de la Reproduction, CHU de Poitiers
Presenter
C

Camille Armengaud

Links

Abstract

Hypothesis / aims of study
Sacral colpohysteropexy (hereafter sacropexy) has become the gold standard for the surgical treatment of pelvic organ prolapse (POP). It allows the treatment of multicomportimental POP by placing an anterior vesico-vaginal and vaginal apex (or uterine isthmus) synthetic non-absorbable mesh attached to the anterior vertebral common ligament at the level of the sacral promontory. and a posterior recto-vaginal mesh. Based on historical habits, a prerectal mesh has been systematically placed in the rectovaginal space, in addition to the anterior and apical mesh, in order to prevent de-novo posterior prolapse. Indeed, retrospective comparative studies have not shown a higher risk of recurrence of POP especially rectocele with anterior salcropexy. However, the addition of posterior mesh may increase the risk of surgical complications and de-novo obstructed defecation. Current guidelines do not support systematic prophylactic posterior mesh placement in the absence of rectocele due to the lack of high-level evidence. The aim of is study is to compare reoperations for recurrence and serious complications after anterior sacropexy (ASP) versus double mesh sacropexy (DSP) for anterior and/or apical POP.
Study design, materials and methods
This analysis included patients enrolled in the French, multicenter, prospective VIGI-MESH register since February 2017 who received ASP or DSP for apical and/or anterior POP, excluding patients with rectocele or rectal prolapse or who received concomitant posterior vaginal repair. Follow-up continued until November 2022. All surgeons described each surgical procedure performed on a specific case report form. We checked the data collection by reviewing mesh deliveries from the hospital pharmacies and surgical procedure codes recorded by each hospital's medical data department. We defined serious complications using Clavien-Dindo classification: mesh placement cancelled due to peroperative injury (Grade III), subsequent surgical intervention related to a complication (Grade III), life-threatening complication (Grade IV), woman's death (Grade V). We collected also surgical revisions for prolapse recurrence. We used several sources to identify complications and revisions: the monitoring of surgical procedures by the data departments, surgeons' spontaneous reports, and a questionnaire sent to the women a year later. Serious complications and reoperations for recurrence were compared using Cox proportional hazard models including any associated surgery (hysterectomy or stress urinary incontinence surgery) and a frailty term to consider the center effect.
Results
Between February 2017 and November 2022, 1966 women underwent a sacropexy in 30 centers and agreed to participate: 1313 underwent ASP and 653 DSP. Baseline characteristics did not differ between groups except for the history of hysterectomy, which was more common in patients undergoing DSP (Table). Concomitant hysterectomy (especially sub-total hysterectomy) and concomitant MUS surgery were more common during DSP (Table). The median follow up time was 26 months, IQR: 13 – 46.
Thirty-four patients (1.7%) underwent re-operation for recurrent POP (Figure 1). Of 25 women (1.9%) who required new surgery for POP recurrence after ASP, 20 had anterior and/or apical prolapse, 11 had rectocele and/or elytrocele, and one had rectal prolapse. In the DSP group, nine (1.4%) women required new surgery for POP recurrence: nine had anterior and/or apical prolapse, one had elytrocele, one had rectal prolapse. The route of reoperation was the laparoscopic in six patients, vaginal in 21 patients, both vaginal and laparoscopic in three patients, transanal in one patient and unknown in 3 patients. After adjusting for center effect and the associated surgery (hysterectomy or SUI surgery), the difference between the groups was not significanlty different (adjusted HR, 1.7; 95%CI 0.75, 3.8, p = 0.20). 
We observed twenty-eight (1.4%) serious complications (Figure 2) attributable to the sacropexy: 22 (1.7%) after ASP and 6 (0.9%) after DSP. Sacrocolpopexy was aborted in five women because of adhesions (one woman), vesical wound (one woman), or inaccessible promontory (3 women who benefited from pectopexy instead). Four patients had serious hemorrhage-related complications. Three patients underwent reoperation for gastrointestinal complications (one for appendicitis, one for ileal wound and one for bowel obstruction, all in the ASP group). Three women had serious urologic complications (two vesical wounds diagnosed postoperatively and one ureteral obstruction). Five patients had parietal eventration requiring surgery. One patient was reoperated for a pelvic abscess. One woman underwent pudendal nerve infiltration for painful vaginal granuloma. Seven women underwent reoperation for vaginal exposure of the mesh (five in the ASP group and two in the DSP group). At reoperation, six patients had partial or complete removal of the mesh (four after ASP and two after DSP).
After adjusting for center effect and the associated surgery, the difference between the groups was not significantly different (adjusted HR, 2.1; 95%CI 0.77, 6.0, p = 0.14).
Interpretation of results
Analysis of the results in our registry shows that the addition of a prophylactic posterior mesh is not associated with a higher risk of serious complications. The risk of reoperation for POP recurrence seems higher after ASP without reaching a statistically significant difference. One limitation of our study is that it only recorded recurrences requiring revision with a medium term follow up and may underestimate a potential benefit of DSP.
Concluding message
Serious complications and reoperation for POP recurrence after ASP and DSP are not significantly different. However, our results do not allow us to conclude that there is no inferiority with regard to the risk of recurrence. The risk of reoperation, either for recurrence or complication were reassuring and may help surgeons and patients in shared decision making regarding the addition of a prophylactic posterior mesh in the absence of rectocele.
Figure 1 Figure 1/ Cumulated incidence of reoperation for POP recurrence
Figure 2 Figure 2: Cumulative incidence of serious complications (Clavien Dindo III and more)
Figure 3 Table: The baseline characteristics of patients at the index surgery of sacropexy and intraoperative characteristics
References
  1. Huguier J, Scali P. [Posterior suspension of the genital axis on the lumbosacral disk in the treatment of uterine prolapse]. Presse Med 1958;66(35):781-4
  2. Ganatra AM, Rozet F, Sanchez-Salas R, et al. The current status of laparoscopic sacrocolpopexy: a review. Eur Urol 2009;55(5):1089-103. doi: 10.1016/j.eururo.2009.01.048
  3. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205–13.
Disclosures
Funding Agence Nationale de Sécurité du Médicament et des produits de santé (National Medicines Agency) Clinical Trial No Subjects Human Ethics Committee Comité de Protection des Personnes Ouest III (institutional review board) (IDRBC 2017-A000308-45) Helsinki Yes Informed Consent Yes
15/07/2024 09:34:23