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1.
Int Urogynecol J ; 35(1): 227-236, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38165443

ABSTRACT

INTRODUCTION AND HYPOTHESIS: Women with central sensitisation syndrome (CSS) experience poorer subjective post-operative outcomes even after successful pelvic floor reconstruction. This study tests the hypothesis that women with pelvic floor symptoms (PFS) without relevant pelvic organ prolapse (POP), are more likely to have CSS. METHODS: A questionnaire was sent to women who participated in the POP-UP study in 2017. The POP-UP study evaluated POP in 247 women 16 years after laparoscopic or vaginal hysterectomy. POP-Q data and Pelvic Floor Distress Inventory (PFDI-20) results were used and supplemented with CSS-specific questionnaires. A Central Sensitisation Inventory (CSI) score above 40 implicates CSS. Women were divided into groups based on POP beyond the hymen in relation to the PFDI-20 score. Outcomes of women with PFS and without POP (called 'group 1') were compared with the rest of the cohort (groups 2-4; women without PFS and/or with POP). RESULTS: A total of 136 women were included in the analysis. A CSI score above 40 was present in 16 out of 42 women of group 1 (37%) versus 11 out of 93 women of groups 2-4 (12%), p < 0.0001. Passive coping was more prevalent in group 1 (p = 0.039), and more deviations in somatisation, depression, anxiety and distress were found in group 1 (p values of < 0.0001, 0.018, 0.003 and 0.002 respectively). CONCLUSIONS: This study suggests that CSS might be more prevalent in women with PFS without relevant POP. More awareness of CSS and valid individual counselling may overcome unnecessary surgery for POP and help in setting realistic expectations.


Subject(s)
Pelvic Floor , Pelvic Organ Prolapse , Female , Humans , Pelvic Floor/surgery , Central Nervous System Sensitization , Pelvic Organ Prolapse/complications , Pelvic Organ Prolapse/surgery , Pelvic Organ Prolapse/diagnosis , Surveys and Questionnaires , Hysterectomy, Vaginal , Quality of Life
2.
BJOG ; 130(13): 1568-1578, 2023 12.
Article in English | MEDLINE | ID: mdl-37271736

ABSTRACT

BACKGROUND: Laparoscopic uterosacral ligament suspension (LUSLS) is a technique to correct apical pelvic organ prolapse (POP) by shortening the uterosacral ligaments with sutures. OBJECTIVE: A systematic review with meta-analysis of the effectiveness and safety of LUSLS as treatment for apical POP. SEARCH STRATEGY: PubMed and Cochrane search using 'pelvic organ prolapse', 'laparoscopy' and 'uterosacral', including synonyms. SELECTION CRITERIA: All articles in English presenting outcome of an original series of women with LUSLS as treatment of apical POP. Case reports were excluded. DATA COLLECTION AND ANALYSIS: Study enrollment was performed by two reviewers. Our primary outcome measures were objective and subjective effectiveness of the procedure. Secondary outcome measures regarded complications and recurrence. Bias was assessed with the Newcastle Ottawa Scale. MAIN RESULTS: Of 138 hits, 13 studies were included with 933 LUSLS patients. The average follow-up was 22 months. All were nonrandomised cohort studies. The pooled anatomic success rate is 90% for all LUSLS procedures (95% confidence interval [CI] 83.3-95.5). LUSLS with hysterectomy resulted in an anatomic success rate of 96.6% (95% CI 87.5-100) and LUSLS with uterus preservation 83.4% (95% CI 67.7-94.6). The pooled subjective cure rate was 90.5% (95% CI 81.9-96.5). The rate of major complications was 1%. CONCLUSIONS: Laparoscopic uterosacral ligament suspension (with or without uterus preservation) seems to be an effective and safe treatment for women with apical POP, but long-term prospective trials and randomised controlled trials are necessary to confirm these findings.


Subject(s)
Laparoscopy , Pelvic Organ Prolapse , Female , Humans , Treatment Outcome , Prospective Studies , Uterus/surgery , Pelvic Organ Prolapse/surgery , Ligaments/surgery , Laparoscopy/adverse effects , Laparoscopy/methods , Gynecologic Surgical Procedures/adverse effects , Gynecologic Surgical Procedures/methods
3.
BJOG ; 130(12): 1542-1551, 2023 11.
Article in English | MEDLINE | ID: mdl-37132094

ABSTRACT

OBJECTIVE: To determine whether laparoscopic sacrocolpopexy (LSC) or vaginal sacrospinous fixation (VSF) is the most optimal surgical treatment in patients with POP-Q stage ≥2 vaginal vault prolapse (VVP). DESIGN: Multicentre randomised controlled trial (RCT) and prospective cohort study alongside. SETTING: Seven non-university teaching hospitals and two university hospitals in the Netherlands. POPULATION: Patients with symptomatic post-hysterectomy vaginal vault prolapse, requiring surgical treatment. METHODS: Randomisation in a 1:1 ratio to LSC or VSF. Evaluation of prolapse was done using the pelvic organ prolapse quantification (POP-Q). All participants were asked to fill in various Dutch validated questionnaires 12 months postoperatively. MAIN OUTCOME MEASURES: Primary outcome was disease-specific quality of life. Secondary outcomes included composite outcome of success and anatomical failure. Furthermore, we examined peri-operative data, complications and sexual function. RESULTS: A total of 179 women, 64 women randomised and 115 women, participated in a prospective cohort. Disease-specific quality of life did not differ after 12 months between the LSC and VSF group in the RCT and the cohort (RCT: P = 0.887; cohort: P = 0.704). The composite outcomes of success for the apical compartment, in the RCT and cohort, were 89.3% and 90.3% in the LSC group and 86.2% and 87.8% in the VSF group, respectively (RCT: P = 0.810; cohort: P = 0.905). There were no differences in number of reinterventions and complications between both groups (reinterventions RCT: P = 0.934; cohort: P = 0.120; complications RCT: P = 0.395; cohort: P = 0.129). CONCLUSIONS: LSC and VSF are both effective treatments for vaginal vault prolapse, after a follow-up period of 12 months.


Subject(s)
Laparoscopy , Pelvic Organ Prolapse , Female , Humans , Gynecologic Surgical Procedures/adverse effects , Vagina/surgery , Pelvic Organ Prolapse/surgery , Pelvic Organ Prolapse/etiology , Hysterectomy/adverse effects , Treatment Outcome , Surgical Mesh/adverse effects , Laparoscopy/adverse effects
4.
BMC Womens Health ; 23(1): 115, 2023 03 21.
Article in English | MEDLINE | ID: mdl-36944980

ABSTRACT

BACKGROUND: The aim of this study was to describe the natural course of pelvic floor symptoms and pelvic floor anatomy for women long-term after hysterectomy. METHODS: Women who underwent hysterectomy between 1996-2004 carried out the PFDI-20 questionnaire and POP-Q examination. We collected data on the presence and type of pelvic floor symptoms and its relation to the degree of pelvic organ prolapse (POP) per compartment (≥ stage 2). RESULTS: We obtained data from 247 women on average sixteen years after hysterectomy, with no prolapse (n = 94), anterior prolapse (n = 76), posterior prolapse (n = 38), both anterior- and posterior prolapse (n = 20), and a prolapse involving the vaginal vault (n = 19). Of all 153 women with ≥ stage 2 prolapse, 80 (52%) experienced moderate and/or severe symptoms of the PFDI-20. Most frequently reported symptoms by women with POP were uncontrollable flatus, urinary frequency and urge incontinence. Bulging was associated with a prolapse beyond the hymen. 39% Of women without prolapse experienced bothersome pelvic floor symptoms as well. Most often these were stress incontinence, straining to pass stool and incomplete bowel emptying. Women with a history of hysterectomy for prolapse have more pelvic floor symptoms than women who underwent hysterectomy for other indications, regardless of the current presence of POP (57% versus 40%, p = 0.009). CONCLUSION: In a group of post-hysterectomy women who did not actively seek help, 47% experienced problematic pelvic floor symptoms, independent of the presence or absence of an anatomic POP. Creating more knowledge and awareness of the impact of hysterectomy on the pelvic floor can help women in the future. TRIAL REGISTRATION: The study was registered in the Dutch Trial Registry; Trial NL5967 (NTR6333, 2017-02-01) and approved by the Medical Research Ethics Committee of the Máxima Medical Center (NL60096.015.16, 2017-02-24).


Subject(s)
Pelvic Organ Prolapse , Urinary Incontinence, Stress , Female , Humans , Hysterectomy/adverse effects , Pelvic Floor , Pelvic Organ Prolapse/surgery , Surveys and Questionnaires , Urinary Incontinence, Stress/etiology , Vagina
5.
Int Urogynecol J ; 34(1): 211-223, 2023 01.
Article in English | MEDLINE | ID: mdl-35482083

ABSTRACT

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) is a frequent occurring health issue, especially concerning elderly women. The objective of this study is to examine the long-term outcomes of laparoscopic sacrohysteropexy (LSH) and vaginal sacrospinous hysteropexy (SSHP) for treatment of uterine prolapse. METHODS: A retrospective study of patients who underwent a LSH or SSHP. Validated questionnaires and an outpatient examination visit were used to investigate the effects of both surgical treatments. The primary outcome was the composite outcome of success for the apical compartment, defined as no recurrence of uterine prolapse (POP-Q measurement C ≤ 0), no subjective recurrence of POP, and/or not requiring therapy for recurrent prolapse. Secondary outcomes were peri- and postoperative data, anatomical failure, prolapse beyond hymen, subjective outcomes, and disease-specific quality of life. RESULTS: We included 105 patients, 53 in the LSH group and 52 in the SSHP group. The overall response rate of the questionnaires was 83% (n = 87) after a mean follow-up time of 4.5 years (54.2 months; 95% CI 44.8-64.2 months) in the LSH group and 2.5 years (30.1 months; 95% CI 29.3-31.5 months) in the SSHP group. There were no clinically relevant differences between the study groups in composite outcome of success (p = 0.073), anatomical failure of the apical compartment (p = 0.711), vaginal bulge symptoms for which patients consulted professionals (p = 0.126), and patient satisfaction (p = 0.741). The operative time was longer in the LSH group (117 min; interquartile range (IQR) 110-123) compared to the SSHP group (67 minutes; IQR 60-73) (p < 0.001). The duration of hospital stay was also longer in the LSH group (4 days) than in the SSHP group (3 days) (p = 0.006). CONCLUSIONS: LSH and SSHP seem to be equally effective after long-term follow-up in treating uterine prolapse in terms of objective and subjective recurrence.


Subject(s)
Laparoscopy , Pelvic Organ Prolapse , Uterine Prolapse , Female , Humans , Aged , Uterine Prolapse/surgery , Retrospective Studies , Quality of Life , Treatment Outcome , Gynecologic Surgical Procedures , Pelvic Organ Prolapse/surgery
6.
Int Urogynecol J ; 34(1): 93-104, 2023 01.
Article in English | MEDLINE | ID: mdl-36112182

ABSTRACT

INTRODUCTION AND HYPOTHESIS: The objective of this study was to evaluate long-term outcomes of laparoscopic sacrocolpopexy (LSC) versus abdominal sacrocolpopexy (ASC) for vaginal vault prolapse (VVP). METHODS: Long-term follow-up of a multicenter randomized controlled trial (SALTO trial). A total of 74 women were randomly assigned to LSC (n=37) or ASC (n=37). Primary outcome was disease-specific quality of life, measured with validated questionnaires. Secondary outcomes included anatomical outcome, composite outcome of success, complications, and retreatment. RESULTS: We analyzed 22 patients in the LSC group and 19 patients in the ASC group for long-term follow-up, with a median follow-up of 109 months (9.1 years). Disease-specific quality of life did not differ after long-term follow-up with median scores of 0.0 (LSC: IQR 0-17; ASC: IQR 0-0) on the "genital prolapse" domain of the Urogenital Distress Inventory in both groups (p = 0.175). Anatomical outcomes were the same for both groups on all points of the POP-Q. The composite outcome of success for the apical compartment is 78.6% (n = 11) in the LSC group and 84.6% (n = 11) in the ASC group (p = 0.686). Mesh exposures occurred in 2 patients (12.5%) in the LSC group and 1 patient (7.7%) in the ASC group. There were 5 surgical reinterventions in both groups (LSC: 22.7%; ASC: 26.3%, p = 0.729). CONCLUSIONS: At long-term follow-up no substantial differences in quality of life, anatomical results, complications, or reinterventions between LSC and ASC were observed. Therefore, the laparoscopic approach is preferable, considering the short-term advantages. TRIAL REGISTRATION: Dutch Trial Register NTR6330, 18 January 2017, https://www.trialregister.nl/trial/5964.


Subject(s)
Laparoscopy , Pelvic Organ Prolapse , Female , Humans , Follow-Up Studies , Gynecologic Surgical Procedures/methods , Treatment Outcome , Laparoscopy/adverse effects , Laparoscopy/methods , Quality of Life , Pelvic Organ Prolapse/surgery , Pelvic Organ Prolapse/etiology , Surgical Mesh/adverse effects
7.
Int Urogynecol J ; 32(4): 841-850, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33170314

ABSTRACT

INTRODUCTION AND HYPOTHESIS: The objective was to review the long-term prevalence of pelvic organ prolapse (POP) after laparoscopic hysterectomy (LH) compared with vaginal hysterectomy (VH). METHODS: An observational cohort study was conducted amongst women who underwent an LH or a VH for benign indications during the period 1996-2004: the POP-UP study. The prevalence of POP was inventoried by a questionnaire involving the Pelvic Floor Distress Inventory (PFDI-20) and a pelvic floor examination (POP-Q). Women were divided into groups based on route and indication of hysterectomy: LH, VH-1 (for nonprolapse), and VH-2 (prolapse). RESULTS: Four hundred and six of the 706 eligible patients (58%) returned the questionnaire and 247 underwent POP-Q examination. Sixty-eight patients (17%) received treatment for prolapse; 8% LH, 10% VH-1, and 29% VH-2 (Chi-squared test, p < 0.001). The prevalence of vaginal vault prolapse (apical surgery or ≥ stage 2 at POP-Q) was 4.4% for LH and 5.8% for VH-1 (p = 0.707); and 23% for VH-2 (VH-2 versus others, p < 0.0001). The prevalence of prolapse ≥ stage 2 in any compartment was 62% (n = 153) in total and in 42% of the LH group, 51% of the VH-1 group, and 84% of the VH-2 group (Chi-squared test, p < 0.001). A symptomatic POP (anatomical POP ≥ stage 2 with bulging) was present in 11% of the population. CONCLUSIONS: No difference was found in the prevalence of POP between LH and VH for nonprolapse indications. However, POP after VH for prolapse occurs more frequently than after hysterectomy for other indications.


Subject(s)
Laparoscopy , Pelvic Organ Prolapse , Female , Humans , Hysterectomy/adverse effects , Hysterectomy, Vaginal/adverse effects , Laparoscopy/adverse effects , Pelvic Floor , Pelvic Organ Prolapse/surgery , Treatment Outcome
8.
Int Urogynecol J ; 30(4): 581-587, 2019 04.
Article in English | MEDLINE | ID: mdl-30515540

ABSTRACT

INTRODUCTION AND HYPOTHESIS: A great variety of conservative and surgical procedures to correct vaginal vault prolapse have been reported. The aim of this study was to describe practice pattern variation-the difference in care that cannot be explained by the underlying medical condition-among Dutch gynecologists regarding treatment of vaginal vault prolapse. METHODS: A clinical practice survey was conducted from March to April 2017. The questionnaire was developed to evaluate treatment of vaginal vault prolapse. All members of the Dutch Society for Urogynaecology were invited to participate in a web-based survey. RESULTS: One hundred four Dutch gynecologists with special interest in urogynecology responded to the survey (response rate, 44%). As first-choice therapy for vaginal vault prolapse, 78% of the respondents chose pessary treatment, whereas sacrospinous fixation was the second most common therapy choice according to 64% of the respondents. Preferences on how to approach vaginal vault prolapse surgically are conflicting. Overall, the most performed surgery for vaginal vault prolapse is sacrospinous fixation, followed by laparoscopic and robotic sacrocolpopexy. CONCLUSIONS: Gynecologists in The Netherlands manage vaginal vault prolapse very differently. No standardized method could be determined for the treatment of vaginal vault prolapse in The Netherlands, and we observed practice pattern variations.


Subject(s)
Gynecologic Surgical Procedures/statistics & numerical data , Pessaries/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Uterine Prolapse/therapy , Female , Gynecologic Surgical Procedures/methods , Humans , Netherlands , Surveys and Questionnaires
9.
Int Urogynecol J ; 29(1): 99-107, 2018 Jan.
Article in English | MEDLINE | ID: mdl-28600758

ABSTRACT

INTRODUCTION AND HYPOTHESIS: The objective of this study was to compare the functional outcomes after pessary treatment and after prolapse surgery as primary treatments for pelvic organ prolapse (POP). METHODS: This was a prospective cohort study performed in a Dutch teaching hospital in women with symptomatic POP of stage II or higher requiring treatment. Patients were treated according to their preference with a pessary or prolapse surgery. The primary endpoint was disease-specific quality of life at 12 months follow-up according to the prolapse domain of the Urogenital Distress Inventory (UDI) questionnaire. Secondary outcomes included adverse events and additional interventions. To show a difference of ten points in the primary outcome, we needed to randomize 80 women (power 80%, α 0.05, taking 10% attrition into account). RESULTS: We included 113 women (74 in the pessary group, 39 in the surgery group). After 12 months, the median prolapse domain score was 0 (10th to 90th percentile 0-33) in the pessary group and 0 (10th to 90th percentile 0-0) in the surgery group (p < 0.01). Differences in other domain scores were not statistically significant. In the pessary group, 28% (21/74) of the women had a surgical intervention versus 3% (1/39) reoperations in the surgery group (p = 0.01). CONCLUSIONS: In women with POP of stage II or higher undergoing surgery, prolapse symptoms were less severe than in those who were treated with a pessary, but 72% of women who were treated with a pessary did not opt for surgery. TRIAL REGISTRATION NUMBER: Dutch trial register NTR2856.


Subject(s)
Gynecologic Surgical Procedures , Patient Preference , Pelvic Organ Prolapse/therapy , Pessaries , Aged , Female , Gynecologic Surgical Procedures/adverse effects , Humans , Middle Aged , Patient Satisfaction , Pelvic Organ Prolapse/classification , Pessaries/adverse effects , Prospective Studies , Quality of Life , Randomized Controlled Trials as Topic , Treatment Outcome
10.
Int Urogynecol J ; 28(12): 1767-1783, 2017 Dec.
Article in English | MEDLINE | ID: mdl-29038834

ABSTRACT

INTRODUCTION AND HYPOTHESIS: The treatment of post-hysterectomy vaginal vault prolapse (VVP) has been investigated in several randomized clinical trials (RCTs), but a systematic review of the topic is still lacking. The aim of this study is to compare the effectiveness of treatments for VVP. METHODS: We performed a systematic review and meta-analysis of the literature on the treatment of VVP found in PubMed and Embase. Reference lists of identified relevant articles were checked for additional articles. A network plot was constructed to illustrate the geometry of the network of the treatments included. Only RCTs reporting on the treatment of VVP were eligible, conditional on a minimum of 30 participants with VVP and a follow-up of at least 6 months. RESULTS: Nine RCTs reporting 846 women (ranging from 95 to 168 women) met the inclusion criteria. All surgical techniques were associated with good subjective results, and without differences between the compared technique, with the exception of the comparison of vaginal mesh (VM) vs laparoscopic sacrocolpopexy (LSC). LSC is associated with a higher satisfaction rate. The anatomical results of the sacrocolpopexy (laparoscopic, robotic [RSC]. and abdominal [ASC]) are the best (62-91%), followed by the VM. However, the ranges of the anatomical outcome of VM were wide (43-97%). The poorest results are described for the sacrospinal fixation (SSF; 35-81%), which also correlates with the higher reoperation rate for pelvic organ prolapse (POP; 5-9%). The highest percentage of complications were reported after ASC (2-19%), VM (6-29%), and RSC (54%). Mesh exposure was seen most often after VM (8-21%). The rate of reoperations carried out because of complications, recurrence prolapse, and incontinence of VM was 13-22%. Overall, sacrocolpopexy reported the best results at follow-up, with an outlier of one trial reporting the highest reoperation rate for POP (11%). The results of the RSC are too small to make any conclusion, but LSC seems to be preferable to ASC. CONCLUSIONS: A comparison of techniques was difficult because of heterogeneity; therefore, a network meta-analysis was not possible. All techniques have proved to be effective. The reported differences between the techniques were negligible. Therefore, a standard treatment for VVP could not be given according to this review.


Subject(s)
Gynecologic Surgical Procedures/methods , Hysterectomy/adverse effects , Pelvic Organ Prolapse/surgery , Postoperative Complications/surgery , Female , Humans , Laparoscopy/methods , Pelvic Organ Prolapse/etiology , Postoperative Complications/etiology , Sacrum/surgery , Surgical Mesh , Treatment Outcome , Vagina/surgery
11.
BMC Womens Health ; 17(1): 52, 2017 07 26.
Article in English | MEDLINE | ID: mdl-28747206

ABSTRACT

BACKGROUND: Hysterectomy is one of the most performed surgical procedures during lifetime. Almost 10 % of women who have had a hysterectomy because of prolapse symptoms, will visit a gynaecologist for a surgical correction of a vaginal vault prolapse thereafter. Vaginal vault prolapse can be corrected by many different surgical procedures. A Cochrane review comparing abdominal sacrocolpopexy to vaginal sacrospinous fixation considered the open abdominal procedure as the treatment of first choice for prolapse of the vaginal vault, although operation time and hospital stay is longer. Literature also shows that hospital stay and blood loss are less after a laparoscopic sacrocolpopexy compared to the abdominal technique. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Prospective trials comparing vaginal sacrospinous fixation and laparoscopic sacrocolpopexy are lacking. The aim of this randomized trial is to compare the disease specific quality of life of the vaginal sacrospinous fixation and laparoscopic sacrocolpopexy as the treatment of vaginal vault prolapse. METHODS: We will perform a multicentre prospective randomized controlled trial. Women with a post-hysterectomy symptomatic, POP-Q stage ≥2, vaginal vault prolapse will be included. Participants will be randomized to the vaginal sacrospinous fixation group or the laparoscopic sacrocolpopexy group. Primary outcome is disease specific quality of life at 12 months follow-up. Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, sexual functioning, procedure related morbidity, hospital stay, post-operative recovery, anatomical results using the POP-Q classification after one and 5 years follow-up, type and number of re-interventions, costs and cost-effectiveness. Analysis will be performed according to the intention to treat principle and not as a per protocol analysis. With a power of 90% and a level of 0.05, the calculated sample size necessary is 96 patients. Taking into account 10% attrition, a number of 106 patients (53 in each arm) will be included. DISCUSSION: The SALTO-2 trial is a randomized controlled multicentre trial to evaluate whether the laparoscopic sacrocolpopexy or vaginal sacrospinous fixation is the first-choice surgical treatment in patients with a stage ≥2 vault prolapse. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR3977 ; Registered 28 April 2013.


Subject(s)
Colposcopy/methods , Gynecologic Surgical Procedures/methods , Hysterectomy/adverse effects , Laparoscopy/methods , Pelvic Organ Prolapse/surgery , Postoperative Complications/surgery , Adult , Clinical Protocols , Female , Humans , Length of Stay , Middle Aged , Netherlands , Paraspinal Muscles/surgery , Pelvic Organ Prolapse/etiology , Postoperative Complications/etiology , Prospective Studies , Sacrococcygeal Region/surgery , Treatment Outcome , Vagina/surgery
12.
Int Urogynecol J ; 28(10): 1469-1479, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28417153

ABSTRACT

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the functional outcome after laparoscopic sacrocolpopexy versus open sacrocolpopexy in women with vault prolapse. METHODS: A multicentre randomised controlled trial was carried out at four teaching and two university hospitals in the Netherlands in women with symptomatic vault prolapse requiring surgical treatment. Participants were randomised for laparoscopic or open sacrocolpopexy. Primary outcome was disease-specific quality of life measured using the Urinary Distress Inventory (UDI) questionnaire at 12 months' follow-up. Secondary outcomes included anatomical outcome and perioperative data. We needed 74 participants to show a difference of 10 points on the prolapse domain of the UDI 12 months after surgery (power of 80%, α error 0.05). RESULTS: Between 2007 and 2012, a total of 74 women were randomised. Follow-up after 12 months showed no significant differences in domain scores of the UDI between the two groups. After 12 months, both groups reported a UDI score of 0.0 (IQR: 0-0) for the domain "genital prolapse", which was the primary outcome. There were no significant differences between the two groups (p = 0.93). The number of severe complications was 4 in the laparoscopic group versus 7 in the open abdominal group (RR 0.57; 95% CI 0.50-2.27). There was less blood loss and a shorter hospital stay after laparoscopy; 2 (IQR 2-3) versus 4 (IQR 3-5) days, which was statistically different. There was no significant difference in anatomical outcome at 12 months. CONCLUSION: Our trial provides evidence to support a laparoscopic approach when performing sacrocolpopexy, as there was less blood loss and hospital stay was shorter, whereas functional and anatomical outcome were not statistically different.


Subject(s)
Gynecologic Surgical Procedures/statistics & numerical data , Pelvic Organ Prolapse/surgery , Aged , Female , Humans , Middle Aged , Quality of Life , Treatment Outcome
13.
BMC Womens Health ; 14: 112, 2014 Sep 17.
Article in English | MEDLINE | ID: mdl-25231240

ABSTRACT

BACKGROUND: Pelvic organ prolapse is a common health problem: the lifetime risk of undergoing surgery for pelvic organ prolapse by the age of 85 years is 19%. Pelvic organ prolapse has significant negative effects on a woman's quality of life. Worldwide, vaginal hysterectomy is the leading treatment method for patients with symptomatic uterovaginal prolapse. Several studies have shown that vaginal sacrospinous hysteropexy and laparoscopic sacrohysteropexy are safe and effective alternatives in treating uterine descent. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Therefore, we conducted the LAVA trial. METHODS: The LAVA trial is a randomized controlled multicenter non-inferiority trial. The study compares laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy in women with uterine prolapse stage 2 or higher. The primary outcome of this study is surgical success of the apical compartment at 1 and 5 years follow-up. Secondary outcomes are subjective improvement on urogenital symptoms and quality of life (assessed by disease-specific and general quality of life questionnaires), complications following surgery, hospital stay, post-operative recovery, sexual functioning and costs-effectiveness. Evaluation will take place pre-operatively, and 6 weeks, 6 months, 12 months and annually till 60 months after surgery. Validated questionnaires will be used.Analysis will be performed according to the intention to treat principle. Based on comparable recurrence rates of 3% and a non-inferiority margin of 10%, 62 patients are needed in each arm to prove the hypothesis with a 95% confidence interval. DISCUSSION: The LAVA trial is a randomized controlled multicenter non-inferiority trial that will provide evidence whether the efficacy of laparoscopic sacrohysteropexy is non-inferior to vaginal sacrospinous hysteropexy in women with symptomatic uterine prolapse stage 2 or higher. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR4029.


Subject(s)
Gynecologic Surgical Procedures/methods , Ligaments/surgery , Uterine Prolapse/surgery , Uterus/surgery , Vagina/surgery , Female , Humans , Laparoscopy/methods , Netherlands , Quality of Life , Severity of Illness Index , Treatment Outcome
14.
Obstet Gynecol Int ; 2013: 528636, 2013.
Article in English | MEDLINE | ID: mdl-24191158

ABSTRACT

Introduction. Sacrocolpopexy is a generally applied treatment for vault prolapse which can be performed laparoscopically or by open laparotomy. Methods. Between October 2007 and December 2012, we performed a multicenter prospective cohort study in 2 university and 4 teaching hospitals in the Netherlands. We included patients with symptomatic posthysterectomy vaginal vault prolapse requiring surgical treatment, who either had abdominal or laparoscopic sacrocolpopexy. We studied surgery related morbidity, which was divided in pre-, peri-, and postoperative characteristics. Results. We studied 85 patients, of whom 42 had open abdominal and 43 laparoscopic sacrocolpopexy. In the laparoscopic sacrocolpopexy group, estimated blood loss was significantly less compared to the abdominal group: 192 mL (±126) versus 77 mL (±182), respectively (P ≤ .001). Furthermore, hospital stay was significantly shorter in the laparoscopic group (4.2 days) as compared to the abdominal group (2.4 days) (P ≤ .001). The overall complication rate was not significantly different (P = .121). However there was a significant difference in favor of the laparoscopic group in peri- and postoperative complications requiring complementary (conservative) treatment and/or extended admittance (RR 0.24 (95%-CI 0.07-0.80), P = .009). Conclusion. Laparoscopic sacrocolpopexy reduces blood loss and hospital stay as compared to abdominal sacrocolpopexy and generates less procedure related morbidity.

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