Dataset Information

Subjective and objective results 1 year after robotic sacrocolpopexy using a lightweight Y-mesh.

ABSTRACT:

Introduction and hypothesis

The objective of this study was to assess outcomes following robotic sacrocolpopexy using a lightweight polypropylene Y-mesh.

Methods

During our study period, all patients who underwent robotic sacrocolpopexy were enrolled in this single-arm prospective trial. Endpoints included Pelvic Organ Prolapse Quantification (POP-Q) values; Pelvic Floor Distress Inventory, short form 20 (PFDI-20); Pelvic Floor Impact Questionnaire, short form 7 (PFIQ-7); Surgical Satisfaction scores; and the Sandvik Incontinence Severity Index. All surgeries were performed with a pre-configured monofilament type 1 polypropylene Y-mesh (Alyte©, C.R. Bard, Covington, GA, USA). Cure rates at 12 months were calculated using two separate definitions: (1) "clinical cure": no POP-Q points > 0, point C ≤ -5, no prolapse symptoms on the PFDI-20, and no reoperations for prolapse and (2) "objective anatomic cure": POP-Q stage 0 or 1, point C of ≤ -5, and no reoperations for prolapse.

Results

A total of 150 patients underwent robotic sacrocolpopexy and 143 (95 %) were available for 12-month follow-up. Mean age was 58.6 ± 9.8 and mean body mass index was 26.3 ± 4.5. Mean operative time and blood loss were 148 ± 27.6 min (range 75-250 min) and 51.2 ± 32, respectively. There were no mesh erosions or exposures, and mesh edges were not palpable in any patient. At 12 months the clinical cure rate was 95 %, and the objective anatomic cure rate was 84 %. The PFDI-20 mean score improved from 98 at baseline to 17 at 12 months (p < 0.0001); PFIQ-7 scores improved from 59 to 6.5 (p < 0.0001).

Conclusions

Robotic sacrocolpopexy using this lightweight polypropylene Y-mesh offers excellent subjective and objective results at 1 year.

SUBMITTER: Culligan PJ

PROVIDER: S-EPMC4544463 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Sacrocolpopexy has been dubbed the “gold standard” repair for apical pelvic organ prolapse (POP). This study sought to determine a genetic cause for sacrocolpopexy failure by comparing genotypes from 10 women who suffered from early POP reoccurance after sacrocolpopexy surgery, versus 40 randomly selected women with long term success after the same procedure. We objectively defined early overt failure after robotic-assisted laparoscopic sacrocolpopexy as having a pelvic organ prolapse quantification system examination (POP-Q) of stage III or IV occurring in more than one compartment within six months after surgery. All medical records identified during this process were then reviewed by a panel of urogynecology attendings and fellows to select patients who were truly clinical outliers. By this method we identified 10 patients (cases) who experienced early overt surgical failure. We also randomly selected 40 controls from our research database which includes greater than 500 patients who underwent robotic-assisted laparoscopic sacrocolpopexy during the same time period and had been objectively and subjectively assessed for ≥ 12 months with surgical success at ≥ 12 months that did not undergo prolapse re-operation or re-treatment. Demographics and peri-operative details were compared between cases and controls. Exclusion criteria for controls included use of other graft material besides polypropylene mesh, prior surgery for prolapse involving graft material, and conversion to laparotomy. DNA from the 10 cases and 40 controls was isolated from buccal swabs and genotyped on a single nucleotide polymorphism (SNP) array that contains 250,000 markers (NspI 250K SNP array, Affymetrix, Santa Clara, CA). All women in this study identified as Caucasian. All subjects provided written informed consent to study participation and data release. This was a case-control study approved by the Institutional Review Board at the Atlantic Health System in Morristown New Jersey (R11-10-004).

Project description:Sacrocolpopexy has been dubbed the âgold standardâ repair for apical pelvic organ prolapse (POP). This study sought to determine a genetic cause for sacrocolpopexy failure by comparing genotypes from 10 women who suffered from early POP reoccurance after sacrocolpopexy surgery, versus 40 randomly selected women with long term success after the same procedure. We objectively defined early overt failure after robotic-assisted laparoscopic sacrocolpopexy as having a pelvic organ prolapse quantification system examination (POP-Q) of stage III or IV occurring in more than one compartment within six months after surgery. All medical records identified during this process were then reviewed by a panel of urogynecology attendings and fellows to select patients who were truly clinical outliers. By this method we identified 10 patients (cases) who experienced early overt surgical failure. We also randomly selected 40 controls from our research database which includes greater than 500 patients who underwent robotic-assisted laparoscopic sacrocolpopexy during the same time period and had been objectively and subjectively assessed for â¥ 12 months with surgical success at â¥ 12 months that did not undergo prolapse re-operation or re-treatment. Demographics and peri-operative details were compared between cases and controls. Exclusion criteria for controls included use of other graft material besides polypropylene mesh, prior surgery for prolapse involving graft material, and conversion to laparotomy. DNA from the 10 cases and 40 controls was isolated from buccal swabs and genotyped on a single nucleotide polymorphism (SNP) array that contains 250,000 markers (NspI 250K SNP array, Affymetrix, Santa Clara, CA). All women in this study identified as Caucasian. All subjects provided written informed consent to study participation and data release. This was a case-control study approved by the Institutional Review Board at the Atlantic Health System in Morristown New Jersey (R11-10-004). This case-control study compared single genotypes of 10 cases to 40 controls. All subjects were identified as Caucasian. Cases were women who experienced early overt POP recurrence after robotic sacrocolpopexy, and controls were randomly selected women with long term success after the same procedure.