PROSPECTIVE ASSESSMENT OF ROBOTICASSISTED SACROCOLPOPEXY FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE; AEUROPEAN BI-CENTRE COHORT (PARSEC).
F. VAN ZANTEN1, O. E.O'SULLIVAN 2, S. SCHRAFFORDT KOOPS 1, B. A.O'REILLY 2;
1Meander Med. Ctr., Amersfoort,Netherlands, 2CUMH, Cork, Ireland.
Introduction: Whilst the use ofrobotics in the management of female pelvic organ prolapse (POP) isincreasing there is a paucity of data concerning efficiency andefficacy. Criticisms of RCT’s include the variance in surgeonexperience resulting in varying outcome measures such as wide rangesin operating time and complication rates.
Objective: Thepurpose of this prospective cohort study is to provide realisticoutcomes measures from different European centres with experiencedrobotic surgeons.
Methods: All consecutive patientsundergoing a Robotic procedure for uterovaginal prolapse from 2008until 2015 in two tertiary referral units in Europe were enrolled(N=501). All surgery was performed with the da Vinci Si-HD® byexperienced robotic laparoscopic urogynaecologists. For thesuspension a polyprolene mesh was used. The primary outcomes of thisstudy were the anatomic cure rates, safety of the procedure andintra-operative variables such as blood loss and operation time. Thesimplified Pelvic Organ Prolapse Quantification (POP-Q)1,was used to describe the anatomical cure after 1 year offollow-up.
Results: In total 501 patients were included.The median follow-up time was 14.0 months [range 8.0-44.4]. 68Patients were lost to follow-up (13.6%). Patient characteristics arelisted in table 1 and the operative data in table 2. Anatomicresults The median simplified POP-Q improved significantlyfor all four anatomic landmarks (table 3; p<0.0005).Intra-operative complications Twenty intra-operativecomplications were identified (4.0%), eight bladder lesions, of whichone resulted in a conversion and one had a concomitant conversion dueto adhesions. There were two small bowel serosa tears, which wererepaired intraoperatively. Eight surgeries were converted; one forbleeding from the presacral venous plexus, one due to ventilationproblems, one after a bladder lesion as above, three due to adhesionsand two for other reasons. One surgery was cancelled because ofventilation problems. The last complication occurred during a surgerywith massive adhesions, mesh placement on the anterior vaginal wallwas impossible; a small anterior wall colpotomy was made.Postoperative complications There were 38 (7.6%) earlypostoperative complications, most being small complications requiringno or a small intervention. Six (1.2%) patients had a severecomplication (Clavien Dindo Classification ≥3; table 4). Atfollow-up nine patients were identified with mesh erosion (1.8%) ofwhich two were exposed sutures (0.4%). Five patients requiredsurgical removal of the mesh or part of the mesh.
Table1. Patient characteristics.
Table2. Operative data
Techniqueused, N (%)
Concomitantsurgery, N (%)
Meanblood loss, millilitres
Totalsurgery time, minutes
Lengthof stay, nights, median
Meanpain score, VAS
Table3. Anatomic results
Table4. Complications and postoperative procedures
Intra-operativecomplications, N (%)
Earlypostoperative complications; Clavien Dindo Classification. N (%)
Postoperativemortality, N (%)
1(0.2; caused by severe pulmonary embolism)
Latepostoperative complications, N (%)
Conclusions: Currently thisis the largest prospective study assessing the robotic approach forprolapse. The results show the robot provides a safe, minimallyinvasive approach to apical prolapse, without increasing morbidity ormortality. The anatomic cure rates at one year show a significantimprovement. Furthermore, there is a reduced mesh erosion ratecompared to the vaginal route
References: 1. Swift S,Morris S, McKinnie V, et al. Validation of a simplified technique forusing the POPQ pelvic organ prolapse classification system. IntUrogynecol J Pelvic Floor Dysfunct. 2006;17(6):615-620.doi:10.1007/s00192-006-0076-z.