PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFECT OF TOTAL VS SUBTOTAL HYSTERECTOMY ASSOCIATED WITH LAPAROSCOPIC COLPOSACROPEXY

Natale F1, Illiano E2, Agostini M1, Costantini E2

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 12
Urogynaecology 1 - Pelvic Organ Prolapse
Scientific Podium Short Oral Session 2
Wednesday 4th September 2019
09:37 - 09:45
Hall H2
Pelvic Organ Prolapse Prospective Study Quality of Life (QoL) Surgery Female
1.San Carlo di Nancy Hospital, Rome, Italy, 2.University of Perugia, Perugia, Italy
Presenter
E

Ester Illiano

Links

Abstract

Hypothesis / aims of study
The primary objective of this study is to compare the anatomical efficacy and the safety of laparoscopic colposacropexy (L-CSP) associated with total or subtotal hysterectomy. The secondary objective is to evaluate the effects of these two procedures on symptoms and to define their impact on Quality of Life (QoL).
Study design, materials and methods
This is a prospective randomised study on women who underwent L-CSP for symptomatic stage >2 POP in our tertiary urogynaecological centre. Exclusion criteria were previous POP or anti-incontinence surgery, and comorbidities such as diabetes or neurological disease.
Before surgery, all patients underwent urogynaecological work-up including: medical and urogynecological history, pelvic examination under straining in the gynaecological position using POP-Q classification; supine stress test with the prolapse reduced; conventional urodynamic study with and without prolapse reduction using a pessary; questionnaires: the short forms of Incontinence Impact Questionnaire (IIQ-7) and Urinary Distress Inventory (UDI-6) [13] for urinary symptoms, and the Prolapse-Quality of Life Questionnaire (P-QoL) for QoL.
Patients were randomised to undergo L-CSP with total hysterectomy (Group 1) or with subtotal hysterectomy (Group 2)
Randomization was done using a computer-generated list. To ensure adequate concealment we use a one-site computer system combined with allocations kept in a locked, unreadable computer file that investigators can access only after the characteristics of an enrolled participant are entered. 
Patients were followed up at 3, 6 and 12 months and thereafter annually, using the preoperative protocol, with the exception of urodynamic testing. Patients also completed the Patient Global Impression of Improvement (PGI-I) scale, a seven-point scale with a range of responses from 1 (very much improved) to 7 (very much worse) and the Visual Analog Scale (VAS).
The primary outcomes were: (i) anatomical results: objective cure was defined: as ‘good’ when points Ba, C and Bp (anterior, apical and posterior vaginal wall respectively) were at stage 0 at POP-Q; as ‘satisfactory’ at stage 1; as ‘failure’ at stage 2; (ii) safety: complications were evaluated according to the Clavien–Dindo classification. The grade III-a complications on the Clavien scale were evaluated further using the ICS/IUGA classification of mesh complications. 
Secondary outcomes were: (ii) symptoms: presence or absence of storage, voiding, post-micturition and POP-related symptoms; (iii) QoL: score of 0–100 on P-QoL. 
Assuming a two-sided hypothesis test with a 5% type 1error and 80% power, 45 patients in each group would be required to detect an absolute difference of 15% in reduction of complications. We sought to enrol 110 women in this clinical trial in order to allow for a 10% drop-out rate.
Institutional Review Board Committees approved this study (CEAS n. 1635). All participants gave informed consent. Patients with a minimum 24 months follow-up were included in this report.
Statistical analysis: McNemar Chi-square test, T-test, Mann–Whitney test. We considered p<0.05 to be statistically significant.
Results
From September 2010 to September 2016, a total of 119 patients with symptomatic POP> stage 2 were enrolled. Of those, 100 patients were found to be eligible for our study: 50 were randomized in Group 1 and 50 were randomized in Group 2. At the last follow-up we lost to follow-up 4 patients in group 1 e 6 patients in group 2
No significant difference was found between groups in demographic data, degree of POP, and clinical or urodynamic findings.
We had a statistically significant anatomical correction in all vaginal segments in both groups. In particular in Group 1 we had a correction of anterior vaginal prolapse in 91.3% of patients, of central descensus in 93.5% and of posterior vaginal prolapse in 95.7%; in Group 2 we had a correction of anterior vaginal prolapse in 90.9% of patients, of central descensus in 93.2% and of posterior vaginal prolapse in 93.2%.
No intra-operative complications occurred in both groups. Vaginal mesh extrusion was observed in 5 patients in group 1. All 5 were treated with local therapy for three weeks: 3 had complete resolution, and 2 underwent surgical partial removal of the mesh and closure of the defect with complete resolution. No complications were observed in group 2.
Pre and post-operative symptoms of both groups are reported in Table 1.
Comparing post-operative data between the two groups, we found no differences between anatomical or symptomatic results (Table 2). In group 1 we had de novo UUI in 3 patients and de novo constipation in 2 patients. In group 2 we had de novo UUI in 4 patients, de novo dry OAB in 3 patients and de novo constipation in 2 patients
Quality of life was significantly improved in all domains in both groups, according to the King’s Health Questionnaire.
We observed a statistically significant differences between the two groups in the VAS score (mean value 8.84 in group 1 vs 9,45 in group 2 – p=.0263) and in PGI-I score (mean value 1.56 in group 1 vd 1.20 in group 2 – p=0046).
Interpretation of results
Both procedures provide significant anatomical correction of all vaginal segments, with a statistically significant improvement of the urinary symptoms and a good impact on QoL. The patients’ satisfaction was higher in group 2, and this is probably related with the absence of complications in this group.
Concluding message
This study demonstrates that both techniques are equivalent regarding anatomy, function and QoL. L-CSP associated with total hysterectomy has a higher incidence of post-operative complications than the association with a subtotal hysterectomy which, in our opinion, is a factor to consider when selecting the appropriate surgical procedure.
Figure 1 Table 1- Pre and post-operative symptoms in both groups
Figure 2 Table 2- Comparison of post-op results between the two groups
Disclosures
Funding No Clinical Trial Yes Public Registry No RCT Yes Subjects Human Ethics Committee CEAS Umbria Helsinki Yes Informed Consent Yes