Outcomes and learning curve of laparoscopic lateral suspension versus laparoscopic sacrocervicopexy for pelvic organ prolapse: a Randomized Clinical Trial.

Malanowska E1, Rubilotta E2, Starczewski A1, Balzarro M2

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 59
Prolapse
Scientific Podium Short Oral Session 6
Friday 20th November 2020
11:07 - 11:15
Brasilia 2
Pelvic Organ Prolapse Surgery Female
1. Pomeranian Medical University Department of Gynecology, Endocrinology and Gynecology Oncology, Szczecin, Poland, 2. A.O.U.I. Verona, University of Verona, Dept. of Urology, Verona, Italy
Presenter
E

Ewelina Malanowska

Links

Abstract

Hypothesis / aims of study
Laparoscopic approach for pelvic organ prolapse offer many advantages including better anatomical structures identification, shorter hospitalization, decreased postoperative pain and reduced complication rates. Sacro-colpopexy is considered the gold standard in the treatment of apical prolapse, although dissection of the promontory may be challenging. The purpose of the study was to compare two laparoscopic operative techniques, lateral- versus sacro-cervicopexy, in terms of anatomical and functional effectiveness, complications rates, and learning curve.
Study design, materials and methods
From January 2016 to October 2019, we enrolled patients with uterine Pelvic Organ Prolapse Quantification (POP-Q) > stage 2, randomly located for lateral- or sacro-cervicopexy. Inclusion criteria were: uterine prolapse POP-Q > stage 2. Exclusion criteria were: cervical pathologies, previous urogynecological operations, neurological diseases, associated posterior vaginal wall defect, stress urinary incontinence. Data were prospectively collected in a dedicated database. Data collected consisted of: (i) Demographic details; (ii) pre- and post-operative clinical evaluation measurement by POP-Q assessed by maximum Valsalva effort in the seated semi-lithotomy position; (iii) Subjective pre- and post-operative evaluation by PFDI-20 and POPIQ-7 Quality of Life validated questionnaires; (iiii) surgical data (operating time, blood loss); (iiiii) complications, ranked by Clavien-Dindo scale. Follow-up included an outpatient evaluation and the compilation of questionnaires for subjective evaluation at 12 months. The evaluation was carried out in our center by experienced clinician (E.M). Statistical analysis was performed using the Student t-test. P value less than 0.001 was considered statistically significant. To compare data we used linear regression analysis.
Results
89 patients were treated, 51.7% (46/89) underwent sacro-cervicopexy while 48.3% (43/89) had lateral- cervicopexy. The median follow-up was 12 months (SD ). Laparoscopic sacro-cervicopexy anatomic success rates were 90.7% for the apical compartment and 88.37% for the anterior compartment. Laparoscopic lateral suspension anatomic success rates for the apical compartment and for the anterior compartment were 89.1% and 91.3% respectively. We did not observe any increased prevalence of the posterior compartment prolapse in both groups. Quality of life questionnaires showed highly satisfaction with the outcome in both the procedures. Differences in mean operative time were not statistically significant. However, learning curve after 43 procedures was shorter for laparoscopic lateral suspension than for laparoscopic sacrocervicopexy (figure 1-2). None of patients had mesh exposure. In the lateral suspension group there were two bladder injuries rated grade 1 on the Clavien-Dindo. In the sacro-cervicopexy group there was one complication rated grade 3b on the Clavien-Dindo classification: 1 patient required a second-look laparoscopy due to severe lower back pain in the sacral area due to promontory fixation. All these data are resumed in table 1.
Interpretation of results
Lateral- as well as sacro-colpopexy has proven effective and safe in cervical suspension. However, lateral-cervicopexy required shorter learning curve. Lateral suspension does not need promontory preparation which is at high risk of vascular damage and mesh pathway is far from ureter. Furtheromore, this technique has fewer risks than sacro-colpopexy. Thus, lateral-cervicopexy may be easier to learn than sacro-colpopexy  for a novel surgeon.
Concluding message
The laparoscopic lateral suspension is a good alternative to the laparoscopic sacrocervicopexy. 
Lateral-cervicopexy has a shorter learning curve which make it a good surgical choice for a novel surgeon.
Figure 1
Figure 2
Disclosures
Funding None Clinical Trial No Subjects Human Ethics Committee Department Committee for Ethics Helsinki Yes Informed Consent Yes