Short summary

Approximately 300 Danish women are operated annually due to vaginal vault prolapse (VVP) which is a condition associated with decreased quality of health including impaired sexual function and increased risk of urinary- and bowl distress. Several surgical modalities are currently offered patients in Denmark with VVP. The variety implies a lack of consensus concerning best best practice. The study includes evaluation of register data and patient's perspectives by use of validated questionnaires.

Rationale

Hysterectomy is a frequently performed surgical procedure for gynecological diagnoses as bleeding disorders, leiomyomas and prolapse (1,2). Incidence of vaginal vault prolapse (VVP) after hysterectomy is up to 43% (3,4), and recurrence after VVP surgery is known to be as high as 41% (5). During the recent decades, several surgical procedures for VVP has been introduced. The wide variety of surgical treatments available for VVP indicates a lack of consensus as to have found the optimal surgical procedure. The great heterogeneity between study populations makes comparison of surgical procedures challenging. Furthermore, the selection of procedure depends on the patients symptoms, general health, history and anatomical considerations as well as the surgeon's preference and capabilities. Surgical procedures for the treatment of VVP is performed vaginally or abdominally, with native tissue or with synthetic or biological graft. Abdominal procedures can be performed by laparotomy or using conventional laparoscopic and robotically assisted‐laparoscopic techniques (6,7,8). The sacrocolpopexy (SCP) is today the most widely accepted vault suspension procedure using synthetic mesh and is performed through laparotomy or laparoscopically with suspension of the vaginal apex to sacrum (9,10,11). The procedure has been compared to other abdominal and vaginal procedures, and has been shown to be superior in relation to outcomes regarding sexual function, pain and a minimal recurrence of 2,3% (6,7,8,12-19). However, the procedure of SCP implies a risk of erosion due to the use of synthetic mesh, which may be observed in up to 18%, with a need of surgery as a course of erosion in 9,5% (5,15,20,21). The uterosacral-ligament suspension (USLS) is performed by vaginal or laparoscopic route. The latter with improved visual overview and decreased risk of lesion/obstruction of the ureter (22,23,24,25). The vaginal and laparoscopic approach is similar regarding intraoperative and postoperative complications and with no significant difference in surgical success. There is no record of sexual function or pain at follow up (26,27). The sacrospinous fixation (SSLF) is a vaginal approach where the vaginal apex is suspended to the sacrospinous ligament with a graft unilaterally or bilaterally, or suspended with native tissue using non-absorbable or absorbable sutures. The method has been associated with diversity in re-operation rates from 4,6% to 30,6%, and patients reported postoperative pain twice as often compared to uterosacral-ligament suspension (12,4% vs 6,9%) (22,23,24,25). In Denmark there is approximately 300 operations per year with suspension of VVP. Operations are performed in four centers and surgical procedures varies between centers (28). To our knowledge, no study in one nation has assessed the different procedures used to suspend the VVP in order to evaluate re-operation rates, patient satisfaction and recurrence. AIM The overall objective of the DIVA-study is to provide overview of surgical procedures offered to Danish women with VVP. Information will be evaluated related to the surgical procedure on recurrence, re-operation rate and patient satisfaction through register and questionnaire data, journal reviews and additional involving a single center study comparing laparoscopic USLS to vaginal USLS.

Description of the cohort

Study population: We expect approximately 2600 women to be eligible for inclusion based on the number of women who has undergone one of the operations listed below. However, we assume on basis of literature 30% to decline participation, leaving approximately 1800 women to be included in the final study population.

Inclusion criteria: Patients will be identified by the ICD10 codes for vault prolapse DN993 and surgical procedure: Abdominal apical colpopexy: KLEF 50 Abdominal apical colpopexy with mesh (sacrocoplopexi: KLEF 50a Laparoskopic apical colpopexy (LUSLS): KLEF 51 Laparoskopic apical colpopexy with mesh (sacrocolpopexi): KLEF 51a Vaginal apical colpopexy (VUSLS): KLEF 53 Vaginal apical colpopexy with mesh: KLEF 53a Vaginal apical colpopexy with fixation to the sacrospinous ligament (SSLF): KLEF 53b

Data and biological material

The overall objective of the DIVA-study is to provide overview of surgical procedures offered to Danish women with VVP. Information will be evaluated related to the surgical procedure on recurrence, re-operation rate and patient satisfaction through register and questionnaire data, journal reviews and additional involving a single center study comparing laparoscopic USLS to vaginal USLS.

Specific objective 1 The study will provide overview of surgical procedures used for VVP suspension and compare re-operation rates and complications between procedures.

Specific objective 2 To compare overall satisfaction after surgery for VVP according to surgical procedure obtained by register and questionnaire data concerning recurrent prolapse symptoms, recurrence treatment, urinary- and bowl distress symptoms and ability to obtain normal daily activities.

Specific objective 3 To compare sexual function and satisfaction after surgery for VVP according to surgical procedure.

Specific objective 4 To compare laparoscopic assisted uterosacral ligament suspension (L-USLS) to vaginal uterosacral ligament suspension (V-USLS) regarding overall patient satisfaction related to recurrent prolapse symptoms, urinary- and bowl distress symptoms and postoperative pain perception. Further assessed is objective operative measures as surgical complications, length of surgical procedure and hospitalization. This is a single center study, as L-USLS in Denmark is performed only at the Odense University Hospital.

METHODOLOGY All four studies are cohort studies with the advantages of exposure registered before outcome, so that there is no risk of recall bias. The study population in sub-study 1+2+3 is a historical cohort based on DugaBase register data with the strength of having > 90% data completeness. However, a low response rate may invalidate the generalizability of the data. Sub-study 4 is a combination of register based study and prospectively collected data. Prospective studies have limitations as a cause of long follow-up time with increased costs in time and money.

Sub-study 1+2+3: In sub-study 1, 2 and 3 we aim to determine re-operation rates and complications for each surgical procedure offered to women with VVP in Denmark, and evaluate overall patient satisfaction including the feeling of recurrence and sexual function.

Design Sub-study 1, 2 and 3 are register and questionnaire based historical cohort studies, and as for study 1 with additional journal reviews, including women registered in the DugaBase (The National Danish Urogynaecological Database) having performed surgical repair of VVP from 2010 to 2019.

Collaborating researchers and departments

Department of Obstetriscs and gynecology, Aalborg University Hospital

• Senior Consultant Karin Glavind
• Department og Obstetrics and gynecology, Aarhus University Hospital
• Senior Consultant Marianne Glavind-Kristensen

Department of Obstetrics and Gynecology, Herlev-Gentofte Hospital.

• Professor and Senior Consultant Niels Klarskov