From thigh to pelvis: female genital prolapse repair with an autologous semitendinosus tendon transplant : Data of the German multicenter trial.

INTRODUCTION AND HYPOTHESIS: The use of synthetic mesh for prolapse and incontinence surgery is discussed controversially and in several countries is either no longer used or permissible. Previous approaches with autologous tissue did not show from a patient´s perspective convincing long-term results. As there have been repeatedly significant complications with synthetic mesh, a new approach is urgently needed. During orthopedics and trauma surgeries, tendons from the thigh have been used for decades to replace cruciate ligament. The procedure of tendon removal from the thigh is fast, easy to learn and morbidity is low. In addition, a long-term durability of the transplant ought to be expected. The objective of this investigation was to show our experience with a semitendinosus tendon instead of a mesh for genital prolapse repair. METHOD: After the first successful attempts using such tendons in cervicosacropexy and pectopexy in patients with genital prolapse, we initiated a national multicenter study in 2020. Five German hospitals participated in order to determine the feasibility of cervicosacropexy with tendon tissue instead of mesh. RESULT: Up until now, we have operated and observed 113 patients for at least 6 months and have seen stable results in terms of fixation of the apical compartment. The expected low morbidity at the donor site was also confirmed through subjective assessment of the patients (Knee and Osteoarthritis Outcome Score). Improvement of quality of life was confirmed after the procedure with the Short Form Health Survey 12, Version 2.0. The results of this multicenter study showed that the desired elevation of the apical compartment with tendon tissue can be achieved with low morbidity and without a synthetic mesh. CONCLUSION: Women with uterine prolapse can be treated minimally invasively and with very low morbidity by using the semitendinosus tendon. The involvement of multiple (five) medical centers confirms that the technique is easy to learn and be transferred to other clinical centers.

The hysterectomy: influence of the surgical method in benign disease on convalescence and quality of life.

PURPOSE: The aim of this study was to evaluate the postoperative course after different methods of hysterectomy for benign diseases with special emphasis on time to recovery and patient-centred aspects such as postoperative quality of life and satisfaction. METHODS: A collective of 242 women who had undergone vaginal hysterectomy (VH), laparoscopic supracervical hysterectomy (LASH) or total laparoscopic hysterectomy (TLH) for various benign conditions was studied in this retrospective investigation. Patients completed a standardised questionnaire addressing quality of life, recovery and sick leave as well as general questions on their postoperative course after hysterectomy. RESULTS: A total of 242 cases were analysed (82 VH, 92 LASH and 68 TLH). The data demonstrate significant differences in regard to age between groups. The present study shows shorter hospitalisation with laparoscopy, with LASH patients returning to work at least one week earlier on average. There were no relevant differences in the overall postoperative course during the index hospital stay. In the long run, laparoscopic patients were not more satisfied with their choice than VH patients. CONCLUSION: No significant long-term differences could be observed in terms of quality of life and overall postoperative satisfaction between VH and LH groups. In regard to socioeconomic aspects, laparoscopic approaches were associated with shorter hospitalisation and LASH patients returning to work at least one week earlier on average. Contrary to these data on objective recovery; however, a laparoscopic approach did not lead to patient-perceived, i.e. subjective improvement of time to full recovery.

Tendon incontinence repair - First experience with an autologous semitendinosus tendon transplant for urinary stress incontinence treatment.

In a 40-year-old caucasian patient with stress incontinence was a TVT operation performed with an autologous semitendinosus tendon transplant. The operation was done with spinal anesthesia. The tendon of the right musculus semitendinosus was stripped from the popliteal fossa and used instead of a synthetic tape as midurethral sling, as it is done in a classical retropubic TVT procedure. The operation was performed successfully. On the first day after the operation the transurethral catheter was removed, continence was reached, and no urinary retention was seen. Mobility and power of the affected leg did not change.

Tendon Descensus Repair (TENDER) - A prospective clinical feasibility study of tendon transplantation for pelvic organ prolapse repair.

OBJECTIVE: To show the feasibility of tendon transplantation for minimally invasive pectopexy in pelvic organ prolapse repair. STUDY DESIGN: Patients with uterine or vaginal vault prolapse (POP-Q point C Stage 2-4) were offered laparoscopic pectopexy by means of autologous semitendinosus tendon transplantation. This paper presents a case series and describes the technique regarding the first 10 patients who underwent surgery. After preparing the vagina or cervix for laparoscopic pectopexy a tendon of the patient's semitendinosus muscle was stripped and brought intraabdominally through the 10 mm trocar. The tendon was fixed between the cervix or vagina and to the pectineal ligaments on both sides of the pelvis. RESULTS: All operations were performed successfully without complications. Vaginal examination demonstrated the intended elevation of the middle compartment. Mobility and power of the affected leg did not change. Recovery was fast, and discharge was possible between the second and third postoperative day. CONCLUSION: Our approach demonstrates the feasibility and safety of a laparoscopic pectopexy with a semitendinosus autograft instead of a synthetic mesh. The experience from orthopedic surgery shows that a semitendinosus tendon autograft is long-lasting and stable. In addition, the morbidity on the operated leg is low.

Hemodynamic effects of intramyometrial epinephrine injection for blood loss reduction in laparoscopic myomectomy.

PURPOSE: To evaluate changes in hemodynamic effects of intramyometrial epinephrine injection for blood loss reduction in laparoscopic myomectomy. METHODS: A total of 185 women with symptomatic uterine fibroids who underwent laparoscopic myomectomy were enrolled in this study. Eighty-six women (study collective) received an intramyometrial injection of epinephrine and were compared to ninety-nine women (control collective) who underwent laparoscopic myomectomy without an intramyometrial epinephrine injection. Demographic parameters, change of hemodynamic parameters during surgery as well as hemoglobin drop after surgery were analyzed. RESULTS: In the study collective maximum systolic blood pressure (p < 0.001), maximum increase of the systolic blood pressure within 5 min (p = 0.003), duration of hypertension (p = 0.012), maximal (p < 0.001) and mean heart rate (p = 0.005), maximal increase of heart rate within 5 min (p = 0.003) and difference of mean to maximal heart rate (p < 0.001) were higher compared to the control collective. There was no difference in pre- and postoperative hemoglobin levels in both collectives and no intraoperative clinically relevant complication occurred due to intramyometrial epinephrine injection. CONCLUSION: The intramyometrial application of epinephrine seems to be safe but leads to significant alterations of hemodynamic parameters without a significant change in postoperative hemoglobin levels.

Sexual functioning after total versus subtotal laparoscopic hysterectomy.

AIM: To evaluate postoperative sexual functioning and the influence of patients' expectations on the change in sexuality following laparoscopic total (TLH) versus subtotal hysterectomy (LASH). METHODS: A total of 120 women undergoing laparoscopic hysterectomy were preoperatively enrolled in this bicentric prospective study. Sexual functioning (SF) was evaluated using the female sexual function index (FSFI). Additionally, participants filled in a standardised questionnaire concerning expected changes in SF after surgery. At 3, 6 and 12 months following surgery, women were asked again to assess their level of SF (FSFI). Data of women who participated in at least one FSFI follow-up assessment were analysed (n = 92). We compared the change in SF after surgery between patients with TLH (n = 46) and LASH (n = 46). Additionally, we calculated regression analyses with the patients' expectations as a predictor for change in FSFI scores. RESULTS: Comparing the change of FSFI scores after surgery in both collectives revealed differences only 3 months after surgery, as improvement was stronger for the LASH collective compared to the THL group (p = 0.006). There were no changes comparing collectives after 6 (p = 0.663) and 12 (p = 0.326) months. Concerning patients' expectations, for the LASH group baseline SF (p < 0.001), but not expectations (p = 0.567) predicted the strength of change at each of the follow ups: a lower level of baseline SF was linked to a stronger improvement after surgery. For the THL collective, both baseline SF (p < 0.001) as well as patients' expectations (3 months: p = 0.077, 6 months: p = 0.37, 12 months: p = 0.024) predicted the strength of change: both, a lower level of baseline SF and higher expectations towards an improvement predicted a stronger improvement. CONCLUSION: The preservation of the cervix does not show an advantage in improving SF after surgery. Both methods induce a comparable improvement in long-time SF, especially in patients with an impaired sexuality pre-surgery. Furthermore, patients' expectations concerning this matter seem to have an impact on the postoperative outcome; therefore, this circumstance should be considered in future projects.

Changes in sexuality during ulipristal acetate treatment in women with symptomatic uterine fibroids.

OBJECTIVE: To evaluate changes in sexuality in women treated with Ulipristal acetate (UPA) due to symptomatic uterine fibroids. STUDY DESIGN: A total of 102 women with symptomatic uterine fibroids undergoing conservative therapy with UPA were enrolled in this observational study. Sexuality was evaluated before and after a three month UPA treatment using the Female Sexual Functioning Index (FSFI) as well as the Sexual Activity Questionnaire (SAQ). Before treatment was initiated, participants additionally filled in a standardised questionnaire addressing the expected changes in sexuality due to UPA. Demographic parameters, expectations concerning changes in sexuality, and FSFI- and SAQ-scores were analysed. RESULTS: The average age of the study collective was 42.3 years. For the majority of the included women (n = 70; 71.4%) sexuality was rated as an important issue and 86 women (87.8%) did not think that UPA would have an impact on the frequency of sexual intercourse, the quality (n = 91; 92.9%) or frequency of orgasms (n = 87; 88.8%) neither sexual receptivity (n = 88; 89.8%). Full data sets were available for 73 patients (71.6%). The FSFI showed significantly higher sub scores regarding desire (3.6 ±â€¯1.2 vs. 3.9 ±â€¯1.2; p = 0.0012) and arousal (4.2 ±â€¯1.7 vs. 4.4 ±â€¯1.9; p = 0.0151) as well as a higher total score (26.6 ±â€¯9.0 vs. 27.4 ±â€¯9.5; p = 0.0008) after UPA treatment. Regarding the SAQ a statistically significant difference regarding the subscore "habit" was found (p < 0.0001) comparing pre with post interventional scores. CONCLUSION: Sexuality in general seems to be important for women with symptomatic uterine fibroids. As the treatment with UPA appears to improve sexuality, this circumstance can be mentioned in a pre-therapeutic counselling.

Per-oral endoscopic salpingo-oophorectomy (POESY) in humans: a prospective clinical feasibility study.

BACKGROUND AND AIMS: Natural orifice translumenal endoscopic surgery (NOTES) procedure describes a surgical approach using natural orifices. We describe a prospective non-comparative clinical study on transgastric salpingo-oophorectomy in humans. METHODS: Patients with indication for salpingo-oophorectomy were offered the transgastric approach. This paper presents the data of the first 6 patients, in whom the procedure was performed. After gastroscopic incision in the anterior corpus wall we advanced the flexible gastroscope into the abdominal cavity. With the help of a transvaginally introduced 10 mm trocar and, if the uterus was present, an intrauterine manipulator, the salpingo-oophorectomy was performed. The colpotomy was dilated and the specimens were extracted in a bag. The gastrotomy was closed with an over-the-scope-clip and the colpotomy with a running suture. RESULTS: The planned salpingo-oophorectomy was performed successfully in all patients. All patients recovered quickly and were discharged between the third and fifth day. In one patient a gastric bleeding was seen on the first postoperative day. The bleeding was clipped gastroscopically, all other follow ups were uneventful. CONCLUSION: Our study demonstrates the feasibility of the transgastric access to the pelvis. The gastroscope provided excellent optical control and good tissue preparation. Therefore, we conclude that pure NOTES procedures using the transgastric access to the adnexa are feasible. An increasing role of transgastric procedures for diseases in the pelvic region can be expected in particular if new endoscopic platforms with better means of instrumentation and tissue management become available.

Postoperative sexual functioning in total versus subtotal laparoscopic hysterectomy: what do women expect?

PURPOSE: To evaluate sexual functioning and expected changes in sexual functioning in women with planned total versus subtotal laparoscopic hysterectomy. METHODS: A total of 120 women undergoing laparoscopic hysterectomy were preoperatively enrolled in this study with a cross-sectional design. Full data sets were available for 112 patients, so that 56 patients with planned total laparoscopic hysterectomy (TLH) and 56 women with planned laparoscopic supracervical hysterectomy (LASH) were preoperatively assessed. Sexual functioning was evaluated using the female sexual function index (FSFI). Additionally, participants filled in a standardised questionnaire concerning expected changes on sexual function after the procedure. Demographic parameters, expectations concerning postoperative sexuality and FSFI scores were analysed and compared in women undergoing TLH and LASH. RESULTS: There were no significant differences concerning demographic parameters and FSFI scores comparing collectives. Sexuality in general was considered more important in women undergoing LASH (2.88 ± 0.83 vs. 2.48 ± 0.89; p = 0.011). Also, in 29 patients (52%) opting for LASH and 8 (14%) patients undergoing TLH a potential change in postoperative sexuality had an impact on their choice for a subtotal/total hysterectomy, respectively (p < 0.001). CONCLUSION: Patients' expectations concerning preservation of the cervix and postoperative sexuality appear to have the potential to bias investigations comparing total with subtotal hysterectomy. Hence, future research focusing on this issue should be accomplished incorporating patients' expectations stratified by mode of intervention.

Laparoscopic hysterectomy in the overweight and obese: does 3D imaging make a change?

PURPOSE: To evaluate the influence of three-dimensional (3D) high-definition (HD) visualisation in laparoscopic hysterectomy in normal weight, overweight and obese women. METHODS: A retrospective analysis of 180 patients undergoing total laparoscopic hysterectomy (TLH: n = 90) or laparoscopic supracervical hysterectomy (LASH: n = 90) was performed. The study collective consisted of 90 women (TLH: n = 45, LASH: n = 45), who underwent laparoscopic hysterectomy with a 3D HD laparoscopic system. Ninety matched (uterine weight, previous surgeries) women with hysterectomy (TLH: n = 45, LASH: n = 45) performed by the same surgeon with conventional two-dimensional laparoscopy formed the control group. Statistical analysis was accomplished stratifying patients according to body mass index (BMI) (≤24.9, 25-29.9, ≥30.0 kg/m2). In each BMI, collective subtypes of surgery (TLH, LASH) as well as hysterectomies as a whole were analysed. Demographic data and surgical parameters were evaluated. RESULTS: In all BMI subgroups, there were no significant differences concerning demographic parameters. Number of trocar site incisions needed was significantly less in women undergoing 3D compared to 2D laparoscopy independent of BMI. Furthermore, a significantly lower blood loss was revealed using 3D visualisation in LASH subgroups of the normal and overweight collectives. Three-dimensional laparoscopy was additionally associated with a significantly shorter duration of surgery in the TLH subgroup in overweight patients and a lower haemoglobin drop in the LASH subgroup of the obese. CONCLUSION: The need of less trocar site incisions concerning all weight groups as well.

Topical anaesthetic patches for postoperative wound pain in laparoscopic gynaecological surgery: a prospective, blinded and randomised trial.

PURPOSE: Aim of this prospective study was to investigate the effectiveness of eutectic mixture of local anaesthetic (EMLA) patches on every abdominal incision for pain relief after gynaecologic laparoscopic surgery. METHODS: A total of 121 women were prospectively randomised to receive either placebo (control group) or EMLA (study group) patches on all abdominal incisions. Postoperative pain was assessed 24 and 48 h after surgery using the short form of the McGill Pain Questionnaire (SF-MPQ). The amount of analgesic pain medication on demand was assessed in both groups. RESULTS: Sixty women were allocated to the study group and 61 patients to the control group before laparoscopic surgery. There were no statistically significant differences regarding age, body mass index (BMI), duration of surgery and blood loss comparing both groups. There were no statistically significant differences between both groups with regard to postoperative total pain scores 24 h (McGill total score: 31.77 ± 27.95 vs. 36.80 ± 31.39, p = 0.3535) and 48 h (McGill total score: 19.18 ± 20.09 vs. 26.61 ± 27.70, p = 0.0942) after surgery. Time to mobilisation after surgery (hours) was significantly shorter in the study group (5.01 ± 3.72 vs. 5.78 ± 3.04, p = 0.0423). CONCLUSION: Despite of a significant reduction of time for mobilisation transdermal anaesthetic patches after gynaecologic laparoscopic surgery did not lead to decreased postoperative pain scores.

Does maternal underweight prior to conception influence pregnancy risks and outcome?

AIM: Data analyzing risks during pregnancy and neonatal outcome in Caucasian women with pre-conceptional underweight are scarce. PATIENTS AND METHODS: We conducted a retrospective cohort study in Northern Germany comparing pregnancy risks and neonatal outcomes in nulliparous women with either pre-conceptional underweight or normal weight. RESULTS: The data of 3,854 nulliparous women with either underweight (n = 243; BMI ≤ 18.5 kg/m(2)) or normal weight (n = 3611; BMI 18.5-24.9 kg/m(2)) were screened. The risks for preterm birth (23.3 vs. 18.6%; p = 0.004) and neonatal underweight were significantly higher in women with underweight prior to conception (p < 0.0001). The risk for secondary caesarean sections was significantly lower in underweight patients. CONCLUSION: To our knowledge, the present retrospective cohort study constitutes the largest sub-group analysis on delivery and maternal and neonatal outcome in pre-conceptionally underweight mothers. There are significantly more preterm deliveries in underweight mothers, while maternal outcome and birth-associated trauma (lacerations, caesarean section) is not disadvantageously influenced by maternal underweight. Further investigations are required in order to specify nutritional deficits in underweight pregnant women and to optimize medication in cases where nutritional balance cannot be achieved in order to improve the neonatal status at birth.

Influence of a robotic camera holder on postoperative pain in women undergoing gynaecological laparoscopy.

AIM: To investigate the influence of a robotic camera holder on postoperative pain in women undergoing gynaecological laparoscopy. PATIENTS AND METHODS: Sixty-one women were prospectively enrolled in the study and underwent either conventional laparoscopy or laparoscopy using an active camera holder. Twenty-four and 48 h after surgery abdominal pain was assessed using the short form of the McGill Pain Questionnaire. Demographic data, and clinical and surgical parameters were evaluated. RESULTS: Twenty-seven women underwent laparoscopy with an active camera holder (study group) and 34 women underwent laparoscopy with human camera assistance (control group). Women in the study group were older (43.5±8.6 vs. 37.4±10.4 years; p=0.018) while the duration of surgery was shorter in women who underwent conventional laparoscopy (97±37 vs. 71±33 min; p=0.005). Total pain scores 24 h (28.3±24.2 vs. 44.0±35.0; p=0.049643) as well as 48 h (18.0±20.0 vs. 33.8±31.0; p=0.016) after surgery were significantly less in the study group. CONCLUSION: The usage of a robotic camera holder results in less postoperative pain in women undergoing gynaecological laparoscopy.

Feasibility and perioperative morbidity of minilaparoscopic hysterectomy.

AIM: To analyze the feasibility and perioperative morbidity of minilaparoscopy compared to conventional laparoscopy (CL) in patients undergoing laparoscopic hysterectomy. PATIENTS AND METHODS: Between 04/2012 and 04/2013, 31 patients were prospectively enrolled to undergo hysterectomy via minilaparoscopy with 3.5-mm instruments. A cohort of 108 matched patients who underwent hysterectomy via CL performed by the same surgeon between 08/2011 and 12/2012 served as the control group. RESULTS: There were no statistically significant differences concerning duration of surgery, overall hospital stay and perioperative haemoglobin drop between groups. However, in the study group, the registered blood loss via suction tube was higher (p-value=0.0216) and in two women, intraoperative complications occurred in the form of thermal damage of the ureter via bipolar coagulation. CONCLUSION: Hysterectomy via minilaparoscopy is a feasible laparoscopic approach. Nevertheless, the use of minilaparoscopy should be considered carefully as the reduced diameter of the instruments might impede certain surgical procedures, such as vessel sealing.

Solo surgery--early results of robot-assisted three-dimensional laparoscopic hysterectomy.

OBJECTIVE: Report of our initial experience in laparoscopic hysterectomy by a solo surgeon using a robotic camera system with three-dimensional visualisation. MATERIAL AND METHODS: This novel device (Einstein Vision®, B. Braun, Aesculap AG, Tuttlingen, Germany) (EV) was used for laparoscopic supracervical hysterectomy (LASH) performed by one surgeon. Demographic data, clinical and surgical parameters were evaluated. Our first 22 cases, performed between June and November 2012, were compared with a cohort of 22 age-matched controls who underwent two-dimensional LASH performed by the same surgeon with a second surgeon assisting. RESULTS: Compared to standard two-dimensional laparoscopic hysterectomy, there were no significant differences regarding duration of surgery, hospital stay, blood loss or incidence of complications. The number of trocars used was significantly higher in the control group (p <.0001). All hysterectomies in the treatment group were performed without assistance of a second physician. CONCLUSION: Robot-assisted solo surgery laparoscopic hysterectomy is a feasible and safe procedure. Duration of surgery, hospital stay, blood loss, and complication rates are comparable to a conventional laparoscopic hysterectomy.

Full High-definition three-dimensional gynaecological laparoscopy--clinical assessment of a new robot-assisted device.

AIM: To investigate the clinical assessment of a full high-definition (HD) three-dimensional robot-assisted laparoscopic device in gynaecological surgery. PATIENTS AND METHODS: This study included 70 women who underwent gynaecological laparoscopic procedures. Demographic parameters, type and duration of surgery and perioperative complications were analyzed. Fifteen surgeons were postoperatively interviewed regarding their assessment of this new system with a standardized questionnaire. RESULTS: The clinical assessment revealed that three-dimensional full-HD visualisation is comfortable and improves spatial orientation and hand-to-eye coordination. The majority of the surgeons stated they would prefer a three-dimensional system to a conventional two-dimensional device and stated that the robotic camera arm led to more relaxed working conditions. CONCLUSION: Three-dimensional laparoscopy is feasible, comfortable and well-accepted in daily routine. The three-dimensional visualisation improves surgeons' hand-to-eye coordination, intracorporeal suturing and fine dissection. The combination of full-HD three-dimensional visualisation with the robotic camera arm results in very high image quality and stability.

Pure natural orifice transluminal endoscopic surgery (NOTES) involving peroral endoscopic salpingo-oophorectomy (POESY).

OBJECTIVE: Natural orifice transluminal endoscopic surgery (NOTES) is a surgical approach that uses natural orifices to gain access to areas of the body. In the present article, we describe the first transgastric pure NOTES salpingo-oophorectomy, which we call peroral endoscopic salpingo-oophorectomy (POESY). METHODS: A woman with BRCA1 mutation presented for prophylactic bilateral salpingo-oophorectomy. We offered her the transgastric approach, having performed more than 25 transgastric appendectomies. After gastroscopic incision in the corpus wall, we advanced the gastroscope into the abdominal cavity. Salpingo-oophorectomy was performed with the help of an intrauterine manipulator and a transvaginally introduced 5-mm trocar. The posterior colpotomy was dilated and the specimens were extracted. The gastrotomy was closed with an over-the-scope clip, and the colpotomy with a running suture. RESULTS: The gastroscope provided excellent optical control and good tissue preparation. Prophylactic bilateral salpingo-oophorectomy was performed successfully via POESY. The patient recovered quickly and was discharged on the third day, with an uneventful follow-up. CONCLUSION: The present case demonstrates the feasibility of transgastric access. The gastroscope provided excellent optical control and good tissue preparation. Therefore, we expect an increasing role of transgastric procedures for diseases in the pelvic region, particularly if new endoscopic platforms with better means of instrumentation and tissue management become available.

Whole-body bioelectrical impedance analysis in assessing upper-limb lymphedema after breast cancer therapy.

AIM: The purpose of this prospective study was to evaluate single-frequency whole-body bioelectrical impedance analysis (BIA) as a predictor for the onset of edema of the upper limb in patients undergoing treatment for breast cancer. MATERIALS AND METHODS: Whole-body BIA was performed before surgery, as well as at two days, and one, three, six and twelve months after surgery. RESULTS: Sixty women undergoing breast cancer surgery were examined, with loss of follow-up of 18 patients. Seven patients (14.3%) developed an edema of the upper limb within the first 12 months after surgery. Resistance (R) using whole-body BIA showed a fairly good performance in terms of sensitivity (85.71%) and specificity (97.4%) at predicting edema. The positive predictive value of 54.6% was unsatisfactory, whereas the negative predictive value was 97.4%. CONCLUSION: Resistance in whole-body BIA can be used to rule-out a developing edema of the upper limb.