Anke R. Mothes

Long-term risk of fibroid recurrence after laparoscopic myomectomy

OBJECTIVE The use of laparoscopic myomectomy as a surgical treatment for uterine leiomyoma is associated with low intraoperative morbidity and short hospitalization. Limited data about the long-term outcome of this surgical approach are available. The aims of this study were to estimate the risk of uterine fibroid recurrence after laparoscopic myomectomy and to identify factors contributing to the rate of fibroid relapse. STUDY DESIGN Between 1996 and 2003, 331 patients underwent laparoscopic myomectomy to treat uterine leiomyoma in our hospital; 224 of these patients consented to participate in our 2009 follow-up survey. Clinical symptomatic uterine leiomyoma recurrence was defined as relapse. Recurrence rates at 24 and 60 months post-operatively were calculated for the study population. Fishers exact tests were used to examine the impacts of factors previously linked to an increased risk of fibroid recurrence, including (1) patient age at the time of initial surgery, (2) pre-operative body mass index, (3) number and localization of uterine leiomyoma removed, and (4) pregnancy and (5) delivery after laparoscopic myomectomy on fibroid recurrence in our study cohort. RESULTS We observed 75 recurrences in 224 patients. The cumulative risk of recurrence was 4.9% at 24 months and 21.4% at 60 months post-operatively. An age of 30-40 years and the presence of more than one fibroid at the time of initial laparoscopic myomectomy were identified as factors significantly increasing the risk of symptomatic recurrence after laparoscopic myomectomy (31.25% and 38.71%, respectively; both p<0.01). CONCLUSION Patients with multiple uterine leiomyoma and those in the third decade of life should be counselled thoroughly about the risk of recurrence prior to laparoscopic myomectomy. The low observed recurrence rate in peri- and postmenopausal patients in our study may support the use of laparoscopic myomectomy as a uterus-preserving surgical alternative beyond the reproductive period.

Combination of pre-emptive port-site and intraoperative intraperitoneal ropivacaine for reduction of postoperative pain: a prospective cohort study.

OBJECTIVE To evaluate the effectiveness of intraoperatively applied local ropivacaine added to standard analgesic therapy in reducing postoperative pain intensity and opioid requirement under routine hospital conditions. STUDY DESIGN In this prospective controlled cohort study, 303 consecutive patients receiving a gynaecological laparoscopic intervention at the Jena University Hospital were included. The study cohort (n=168) received, in addition to standard pain management, a port-site (PS) infiltration with ropivacaine prior to incision and intraperitoneal (IP) instillation at the end of surgery. On the first postoperative day patients answered a validated questionnaire, and requirement of rescue analgesics was assessed. RESULTS Pain intensity was assessed on an 11-point numeric rating scale (NRS) from 0=no pain to 10=most severe pain. Reported pain intensity for movement-related pain was significantly lower (p=.001) in the study group compared with the control group (4.4 (SD 2.4) vs. 5.3 (SD 2.2) respectively). Minimal pain intensity after operation was also significantly lower in the study cohort (2.6 (SD 1.7) vs. 2.1 (SD 1.8), (p=.007)). Significantly fewer patients required rescue opioids for analgesia in the ropivacaine cohort (p=.001). The requested dose of rescue opioid (piritramide) in this cohort was also lower (p=.035) with 6.5mg (SD 4.9) vs. 8.7mg (SD 6.6), and demanded later (p=.001) with 4.3h after surgery vs. 3.1h. Patients in the study cohort experienced less nausea (p=.046). Higher satisfaction scores with pain management were reported in the ropivacaine group 12.7 (SD 2.5) vs. 11.6 (SD 2.8) (p<.001) (16-point NRS with 0=not at all, 15=completely satisfied). CONCLUSION Addition of pre-emptive port-site plus intraperitoneal ropivacaine to standard postoperative analgesic therapy reduced postoperative pain intensity and opioid consumption in gynaecological laparoscopy.

Laparoscopic myomectomy in peri- and post-menopausal women is safe, efficacious and associated with long-term patient satisfaction

OBJECTIVE Women in the peri- and post-menopause may ask for uterus-preserving therapy options when presenting with benign uterine disorders such as symptomatic fibroids. Laparoscopic myomectomy (LM) for patients in the peri- and post-menopause as a surgical alternative to hysterectomy is widely considered to be non-standard treatment. The aim of this study was to analyze safety and outcome of LM beyond the reproductive period. STUDY DESIGN We evaluated the surgical outcome and patient satisfaction for a total of 451 patients: 85 peri- or post-menopausal women as group A and, for reference, 366 premenopausal women in group B, who received LM from 1998 to 2008 in our department. We analyzed data from our medical records and applied a patient questionnaire in September 2009. RESULTS The average number of fibroids removed and size of the leading fibroid were similar in both groups. Time of surgery was different in group A, at 102.8 min, compared to group B, 128.6 min (p<0.01). Rates of intra- (2.21% overall) and post-operative complications (6.22% overall) were comparable for both groups. Post-surgical hospitalization was shorter in group B (4.4 days) compared to group A (5.0 days) (p<0.01). Evaluation of the questionnaire showed high satisfaction with the results of LM in both subgroups with a significantly lower number of relapses in group A (3.5%) compared to group B (11.2%). CONCLUSION Laparoscopic myomectomy as a surgical treatment option in the peri- and post-menopause was characterized by a low rate of complications and relapses as well as a high degree of patient satisfaction in our analysis.

Bilateral minimal tension sacrospinous fixation in pelvic organ prolapse: an observational study

OBJECTIVE To evaluate the safety and the subjective and objective outcomes of bilateral minimal tension sacrospinous fixation for pelvic organ prolapse. STUDY DESIGN This was a single-centre observational study conducted at the University Hospital, Urogynaecological Unit, with a certified urogynaecological surgeon. A cohort of 110 patients receiving modified bilateral sacrospinous fixation following a diagnosis of grade II-IV pelvic organ prolapse and defects of three pelvic compartments. Non-absorbable sutures were placed on each side of the sacrospinous ligament. The main aim was to achieve a minimal tension situation by intentionally leaving suture bridges on both sides of the suspension. The post-surgical follow-up period was 14±7 months. The three characteristics of cure in functional surgery - anatomy, function, and subjective patients judgement - were evaluated in this study. Primary outcomes were anatomic, functional, and subjective cures, that were measured pre- and postoperatively using the POP-Q system values, a validated pelvic quality-of-life questionnaire (P-QoL/D), and interviews regarding expectations, goal-setting, goal achievement, and satisfaction. Secondary outcome measures included data on surgical complications. Data analysis was performed with descriptive statistics, Wilcoxon tests, and Mann-Whitney U-tests. RESULTS A total of 110 patients underwent anterior and posterior colporrhaphy and minimal tension bilateral sacrospinous fixation. An objective anatomic cure was reported for 94.5% of patients, and significant improvement of all prolapse symptoms was observed following surgery (p<0.001). Full or partial fulfilment of the criteria for a subjective cure was demonstrated in 96% of the patients. Only 5.5% of the patients experienced postoperative urinary tract infections. No other complications requiring medical or surgical interventions were reported. CONCLUSION Bilateral minimal tension sacrospinous fixation was associated with low morbidity, as well as excellent anatomic, functional, and subjective results at follow-up.

Systematic classification of uterine cervical elongation in patients with pelvic organ prolapse

OBJECTIVE To define and classify cervical elongation, to compare uterine measurements after prolapse hysterectomy with a non-prolapse control group, and to associate stage of prolapse and degree of cervical elongation. STUDY DESIGN This was a single-centre retrospective case-control study conducted at the University Hospital, Urogynaecological Unit, with a certified urogynaecological surgeon. Data were collected from patients with and without pelvic organ prolapse (POP) who underwent laparoscopically assisted vaginal hysterectomy. Post-hysterectomy uterine cervical elongation was examined using the corpus/cervix ratio (CCR), calculated from measurements taken on photographs. Cervical elongation was classified as physiological (grade 0, CCR>1.5) grade I (CCR>1 and ≤1.5) grade II (CCR>0.5 and ≤1), and grade III (CCR≤0.5). RESULTS Cervical elongation was detected in 288/295 (97.6%) patients in the prolapse group (grade I, 44/288 [15.2%]; grade II, 212 [73.6%]; grade III, 32 [11.1%]). Mean CCR was greater among those with stage II/III than among those with stage IV prolapse (1.0±0.4 vs. 0.8±0.2; p<0.001). Grades of cervical elongation and prolapse stages were associated (p<0.001). Grade I cervical elongation was detected in 26/69 (37.6%), grade II in 5/69, and grade III in 0/69 patients of the control group. Cervical elongation was found more often in the prolapse group compared to the control group (p<0.001). Mean total uterine length did not differ between the prolapse and control groups (8.0±1.6 vs. 8.2±1.3cm), but mean calculated cervical length was greater in the prolapse group than in the control group (4.4±1.1 vs. 3.1+0.8cm; p<0.001). CONCLUSIONS Uterine cervical elongation is found in patients undergoing hysterectomy for pelvic organ prolapse. Cervical elongation grades and prolapse stages are correlated. Defining uterine cervical elongation based on corpus/cervix ratio with grades I-III could be a valuable basic tool for further research.

Systematic assessment of surgical complications in laparoscopically assisted vaginal hysterectomy for pelvic organ prolapse

OBJECTIVE To assess patient safety and complication rates in native tissue vaginal prolapse repair combined with laparoscopically assisted vaginal hysterectomy and prophylactic salpingectomy/salpingoophorectomy. STUDY DESIGN This was a single-centre retrospective study conducted at the University Hospital, Urogynaecological Unit, with a certified urogynaecological surgeon. A cohort of 321 consecutive patients received laparoscopically assisted vaginal hysterectomy for pelvic organ prolapse grade II-IV combined with defect-specific vaginal native tissue repair. Analysis of the total cohort and subgroups according to prolapse grade and concomitant laparoscopic procedures was performed. Students t-tests and chi-squared tests were used for descriptive statistical analysis. Surgical complications were classified using the Clavien-Dindo (CD) classification system of surgical complications. RESULTS Complications were classified as CD I (1.87%), CD II (13.39%), CD IIIa (0.62%), and CD IIIb (1.87%); no CD IV or CD V complication occurred. One (0.31%) intraoperative bladder lesion, but no rectal lesion, ureter lesion, or intraoperative haemorrhage requiring blood transfusion, was noted. The overall morbidity rate, including the intraoperative bladder lesion and the CD I complication, was 18.06%. All (n=321) patients underwent prophylactic salpingectomy. Additional oophorectomy was performed in 222 post-menopausal patients. Pelvic adhesions were found in 123 (38.31%) patients and 148 (46%) patients presented grade IV prolapse. Operating time was longer for grade IV than for grade II/III prolapse (p<0.01), but CD III complication rates did not differ between these groups. Operating time was longer when laparoscopic adhesiolysis was performed (p=0.025), but this factor did not affect CD III complication rates. CONCLUSIONS The combination of vaginal site-specific prolapse repair with laparoscopically assisted hysterectomy leads to low complication rates. Prophylactic salpingectomy or salpingoophorectomy can be performed safely in combination with hysterectomy for pelvic organ prolapse. In terms of surgical safety laparoscopy seems to be a meaningful addition to vaginal native tissue prolapse surgery.

Endometriosis and Beta-hCG > 775 IU/l Increase the Risk of Non-tube-preserving Surgery for Tubal Pregnancy

Introduction Tubal pregnancy is the most clinically relevant form of ectopic pregnancy. Surgery consisting of laparoscopic salpingotomy is the therapeutic gold standard. This study looked at risk factors for non-tube-preserving surgery. The aim was to determine a cut-off value for beta-hCG levels, which could be used to predict the extent of tubal surgery. Materials and Method 97 patients with tubal pregnancy who underwent primary salpingotomy in the Department of Gynecology and Obstetrics of Jena University Hospital between 2010 and 2016 were retrospectively analyzed. A prior medical history of risk factors such as adnexitis, ectopic pregnancy, tubal surgery, treatment for infertility and intrauterine pessary was included in the analysis. The study population was divided into two subgroups: (1) a group which underwent laparoscopic linear salpingotomy, and (2) a group which had laparoscopic partial tubal resection or salpingectomy. Risk factors for salpingectomy were determined using binary logistic regression analysis. Statistical analysis was done using SPSS, version 24.0, to identify risk factors for non-tube-preserving surgery. Results 68 patients (70.1%) underwent laparoscopic salpingotomy and 29 patients (29.9%) had laparoscopic salpingectomy. The two groups differed with regard to age (p = 0.01) but not with regard to the parameters ‘gestational age’, ‘viability and rupture status of the ectopic pregnancy’ or ‘symptoms at presentation’. Patients who were known to have endometriosis prior to surgery or who were diagnosed with endometriosis intraoperatively were more likely to undergo salpingectomy (OR: 3.28; 95% CI: 0.9 – 10.8; p = 0.05). Calculated mean beta-hCG levels were higher in the salpingectomy group compared to the group who had tube-preserving salpingotomy (3277.8 IU/l vs. 9338.3 IU/l, p = 0.01). A cut-off beta-hCG value of 775 IU/l prior to surgery was predictive for salpingectomy with a true positive rate of 86.2% and increased the probability that salpingectomy would be necessary (OR: 5.23; 95% CI: 0.229 – 0.471; p = 0.005). Conclusion Endometriosis and a beta-hCG value of more than 775 IU/l significantly increased the risk for non-tube-preserving surgery in women with tubal pregnancy.

An innovative dual-phase protocol for pulsed ablative vaginal Erbium:YAG laser treatment of urogynecological symptoms

OBJECTIVES To evaluate a dual-phase protocol for vaginal ablative Erbium:YAG laser treatment in pelvic floor medicine. STUDY DESIGN Data from consecutive patients undergoing vaginal Erbium:YAG laser for first-degree pelvic floor complaints at a certified university urogynecological unit were analyzed. Fractional ablative and thermal treatment with adjustable pulse duration, fluence, and pulse interval was performed in single ten-minute treatment course. Followed up interval was 6 weeks including interviews on expectations, goal setting, goal achievement, and satisfaction (EGGS), vaginal pH, and determination of the Gloria-Bachmann-Index (VHI). Post-procedural complications were classified according to definition and classification of the Clavien-Dindo system. RESULTS Of 84 patients treated, 71 (21% pre-, 79% post-menopausal) were evaluated. 27% had single urogynecological symptoms, 35% had three or more combined symptoms. Minor post-procedural complications occurred in three patients (CD I, n = 1; CD II, n = 3). The ranges of fluence, determined according to the atrophy state, in the first and second phases were 15-35 and 3-12 J/cm2, respectively. In patients with genitourinary syndrome of menopause, pre- and post-treatment VHI and pH differed significantly [15.3 ± 4.5 vs. 19.9 ± 2.8 (p < 0.001, Students t test) and 5.2 ± 0.6 vs. 4.8 ± 0.4 (p =  0.024, respectively]. Overall, 82% (n = 58; mean age, 58 ± 12 years) of patients were satisfied with the treatment, 84% (47/56) post-menopausal patients were satisfied. CONCLUSIONS Vaginal ablative Erbium:YAG laser dual-phase protocol for early urogynecological symptoms was successful and safe, with high patient satisfaction and few, minor complications. Prospective studies are needed to confirm our first data.

Systematische Klassifikation der Elongatio cervicis uteri bei Patientinnen mit Descensus genitalis

Ziel: Definition und Klassifikation der Elongatio cervicis uteri, Vergleich uteriner Mase bei Genitaldeszensus mit einer Kontrollgruppe, Korrelation von Deszensusgrad und Elongatiograd. Material und Methoden: Im Fall-Kontroll-Design erfolgte die Datenanalyse nach Hysterektomie bei Genitaldeszensus oder Endometriumhyperplasie/FIGO I Endometriumkarzinom ohne Deszensusbefund. Nach Vermessung der Uteri auf Operationsfotos wurde die Korpus-Zervix-Ratio (CCR) ermittelt. Die Zervix wurde als physiologisch (Grad 0, CCR > 1,5) oder elongiert (Grad I [CCR > 1 und ≤1,5], II [CCR > 0,5 und ≤1], III [CCR ≤0,5]) klassifiziert. Ergebnisse: Bei 97,62% Patientinnen aus der Deszensus-Gruppe lag eine Elongatio cervicis vor (Grad I, 44/288 [15,27%]; II, 212 [73,61%]; III, 32 [11,11%]). Die mittlere CCR war beim Deszensus II. und III. Grades groser, als beim uterovaginalen Totalprolaps (0,96 ± 0,39 vs. 0,75 ± 0,22; p < 0,001). Grad einer Elongation und Deszensusgrad korrelierten (p < 0,001). Wahrend sich eine elongierte Zervix haufiger in der Deszensusgruppe fand (p < 0,001), unterschieden sich die Mittelwerte der uterinen Gesamtlange zwischen den Gruppen nicht (8,00 ± 1,6 vs. 8,22 ± 1,32 cm), die mittlere errechnete Zervixlange war jedoch in der Deszensus-Gruppe groser, als in der Kontrollgruppe (4,40 ± 1,12 vs. 3,14 + 0,87 cm; p < 0,001). Zusammenfassung: Eine Elongation der uterinen Zervix konnte bei der Mehrzahl der im Rahmen einer Deszensusoperation hysterektomierten Patientinnen gefunden werden. Der uterovaginale Totalprolaps war mit hohergradiger Elongatio korreliert. Die auf der Korpus-Zervix-Ratio basierende Definition und Klassifikation der Elongatio cervicis kann ein wertvoller wissenschaftlicher Beitrag zur weiteren Untersuchung morphologischer Veranderungen des Uterus beim Genitaldeszensus sein.

Akutschmerzanalyse nach gynäkologischen Operationen: Eine unizentrische, prospektive Register-basierte Studie an 3020 Patientinnen

Fragestellung: Die Leitlinien zur postoperativen Schmerzbehandlung stellen eine evidenzbasierte und eingriffsorientierte Zusammenfassung der aktuellen Therapieempfehlungen zur Reduktion postoperativer Schmerzen dar. Die reale Versorgung der Patienten kann dennoch unzureichend sein und fur einzelne Eingriffsarten gezielt signifikant verbessert werden (Cruz et al. Eur J Obstet Gynecol Reprod Biol. 2014). Das Ziel der vorliegenden Untersuchung ist die Evaluation postoperativer Schmerzen in einer Universitatsfrauenklinik mittels des QUIPS-Systems (Qualitatsverbesserung in der postoperativen Schmerztherapie, www.quips-projekt.de). Methodik: Periodenweise erhielten konsekutive Patienten, die von Januar 2011 bis aktuell in der Universitatsfrauenklinik Jena operiert wurden, am ersten postoperativen Tag von einem an der Behandlung nicht beteiligten Mitarbeiter des QUIPS-Projekts einen validierten Schmerzfragebogen. Zeitgleich wurden objektive Daten zur Schmerzbehandlung sowie demographische Daten erhoben und in eine zentrale Datenbank eingespeist. Ergebnis: Evaluiert werden Daten von Patienten, die die Einschlusskriterien des QUIPS-Projekts erfullten. Bis Februar 2016 wurden 3020 Datensatze erhoben. Weniger als 8% der Patienten lehnten die Teilnahme an der Befragung ab. Anhand der Daten wird ein Ranking der schmerzhaftesten Operationen erstellt. Der Einfluss unterschiedlicher Faktoren auf das Auftreten von starken postoperativen Schmerzen (NRS > 5) wird dargestellt. Die Einfluss-Faktoren OP-Dauer, Verwendung von Drainagen, Zeitpunkt des OP-Beginns, Anwendung von innovativen Masnahmen zur Schmerzreduktion (Wundinfiltration, Opiatprophylaxe etc.), Alter der Patienten werden untersucht. Die Daten sollen auf dem DGGG-Kongress vorgestellt werden. Schlussfolgerung: Diese Studie identifiziert besonders schmerzhafte Eingriffe und definiert Risikofaktoren fur die Entwicklung starker postoperativer Schmerzen. Dadurch konnten Risikopatientinnen zukunftig eine individualisiertere, perioperative Schmerzpravention bzw. -behandlung erhalten.