Effectiveness of Laparoscopic Sacropexy. 2 year follow-up of a population-based FINPOP-cohort.

Karjalainen P1, Mattsson N2, Nieminen K3, Tolppanen A4, Jalkanen J1

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 14
Urogynaecology 1 - Pelvic Organ Prolapse
Scientific Podium Short Oral Session 2
Wednesday 4th September 2019
09:52 - 10:00
Hall H2
Pelvic Organ Prolapse Prospective Study Prolapse Symptoms Quality of Life (QoL)
1.Central Finland Central Hospital, Finland, 2.Kanta-Häme Central Hospital, Finland, 3.Tampere University Hospital, Finland, 4.University of Eastern Finland, Finland
Presenter
P

Päivi Kristiina Karjalainen

Links

Abstract

Hypothesis / aims of study
Robust evidence supports the efficacy of sacrocolpopexy in treating apical pelvic organ prolapse (POP).  It is considered to be the most durable option in treating vault prolapse after hysterectomy [1] and used increasingly for uterine prolapse. Also, it can be combined with ventral rectopexy when treating multicompartment prolapse with involvement of rectal prolapse / intussusception. 

The aim of this study was to assess the effectiveness of laparoscopic sacrocolpopexy and sacrocolporectopexy in a population-based cohort. We also aimed to describe the annual rate of laparoscopic sacropexies in Finland.
Study design, materials and methods
We used data from FINPOP study, a nationwide longitudinal cohort study including 3535 POP surgeries performed during one year in Finland. All hospitals performing POP surgery were invited to recruit women undergoing POP surgery during 2015. 41 of 45 hospitals participated and the operations included 83 % of the operations done for POP in the whole country during the study period. The surgeons decided the method of surgery according to their normal practice. For the present analysis, we included women who had laparoscopic sacropexy.

The surgeons filled in questionnaires on baseline characteristics including patients’ previous surgical history, degree of prolapse (using simplified Pelvic Organ Prolapse Quantification system, POP-Q) and details of the surgery. Participants filled in questionnaires at baseline, and at six and 24 months after the surgery. Complication data was retrieved from surgeon questionnaires and discharge register of the National Institute for Health and Welfare.

Symptom severity was assed using validated Pelvic Floor Distress Inventory questionnaire (PFDI-20). PFDI-20 consists of three scales: six questions about inconvenience of the prolapse (POPDI-6), eight questions concerning defecation (CRADI-8) and six questions about bladder function (UDI-6). Patients also rated perceived global improvement with a 7-point Likert scale (Patient Global Impression of Improvement Scale, PGI-I).

Continuous outcomes within groups were compared using paired T-test and between groups using T-test. Binary outcomes were compared using Fisher’s Exact test. P>0.05 is reported as non-significant (NS).
Results
We identified 226 (6.4% of all 3535 operations) laparoscopic sacropexies. 154 (68%) were sacrocolpopexies (without rectopexy) and 72 (32%) were sacrocolporectopexies. Of the 154 sacrocolpopexies, 132 (86%) were performed for vault prolapse and 22 (14%) for uterine prolapse. Operations were performed in 18/45 hospitals, the rate varying between 1-43 cases / hospital.

The baseline characteristics and concomitant surgeries are shown in table 1. Participants undergoing sacrocolpopexy had more often history of previous POP surgery and hysterectomy and had more often advanced apical prolapse compared with participants undergoing sacrocolporectopexy. Participants undergoing sacrocolporectopexy had more often advanced posterior wall prolapse. Concomitant anterior and posterior repair were rare. No concomitant anti-incontinence procedures were performed.

Perioperative complication rate was comparable among sacrocolpopexy and sacrocolporectopexy participants. Among patients undergoing sacrocolpopexy, there was 1 (0.6%) conversion, 3 (1.9%) bladder injuries, 1 (0.6%) ureteric injury and 3 (1.9%) bowel injuries. Among patients undergoing sacrocolporectopexy, there were no conversions, and one bladder, one ureteric and one bowel injury (1.4%). Twelve participants (7%) reported having had repeat surgery for recurrent prolapse (any site) by 2-year follow-up.

PFDI-20 and PGI-I data was available for 184/226 (81%) participants both pre- and postoperatively (either 6 month or 24 month). PFDI-20 data is given in table 2. The mean PFDI-20 total score and its subscales improved significantly from baseline to 6 and 24 months among sacrocolpopexy and sacrocolporectopexy patients. The mean improvement in PFDI-20 score was approximately two times greater than the minimal important difference (MID = 23 points). [2]

Of sacrocolpopexy participants, 95% assessed their condition improved at six months (very much better 53%, much better 32%, a little better 9%) and 96% at 24 months (very much better 40%, much better 46%, a little better 10%). Of sacrocolporectopexy participants, 92 % assessed their condition improved at six months (very much better 33%, much better 33%, a little better 27%) and 90% at 24 months (very much better 33%, much better 25%, a little better 33%).
Interpretation of results
Laparoscopic sacrocolpopexy and sacrocolporectopexy reduce POP related symptoms effectively in a population-based cohort. Improvement measured by PFDI-20 is clearly higher than is considered clinically meaningful.  Most of the patients experience subjective global improvement.
Concluding message
Laparoscopic sacrocolpopexy and sacrocolporectopexy are viable options in treating patients with pelvic organ prolapse; morbidity is low, and they offer clinically meaningful symptom improvement.
Figure 1 Table 1
Figure 2 Table 2
References
  1. Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with apical vaginal prolapse. Cochrane Database Syst Rev. 2016;10:CD012376.
  2. Utomo E, Blok BF, Steensma AB, Korfage IJ. Validation of the Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7) in a Dutch population. Int Urogynecol J (2014) 25:531-544.
Disclosures
Funding Financial support for this project was provided by Finnish Society for Gynecological Surgery, a non-profit organization. Dr Karjalainen has received grants from Finnish Cultural Foundation, The Finnish Medical Foundation and State Research Funding/Hospital District of Northern Savo. Funding sources did not have involvement with analysis or interpretation of the data. No funding from medical industry was received. Clinical Trial Yes Registration Number ClinicalTrial.gov NCT02716506 RCT No Subjects Human Ethics Committee The Research Ethics Committee of the Northern Savo Hospital District approved the study on 20th of May 2014 (Reference number 5//2014) and each participating hospital granted an approval for conducting the study Helsinki Yes Informed Consent Yes