Evaluation of complications, conversion rate, malignancy rate, and, surgeon's experience in laparoscopic assisted supracervical hysterectomy (LASH) of 1274 large uteri: A retrospective study.

INTRODUCTION: Hysterectomy now belongs to standard gynecological procedures. Moreover, a shift towards laparoscopic techniques is ever more apparent as they provide many advantages such as less traumatization and shorter convalescence. Large uteri are still mentioned as contraindications for laparoscopic hysterectomy even though those patients might benefit from the lower morbidity associated with minimal invasive techniques. In this study, the largest reported so far, we analyzed intraoperative and postoperative complications as well as the surgeon's experience of laparoscopic assisted supracervical hysterectomy (LASH) in patients with a uterus weight over 500 g. MATERIAL AND METHODS: The present retrospective study, between June 27, 1998 and August 31, 2019, evaluates 1274 patients with a uterus weight over 500 g who were treated with LASH for benign uterine diseases at the Clinic for Minimal Invasive Surgery (Berlin, Germany). All surgeries were performed by one of four in-house surgeons with experience in LASH: they had performed at least 500 LASH procedures before the study. Patients receiving surgical treatment for malignant tumors were not included in the study. Major and minor intraoperative and postoperative complications were recorded and evaluated. Additionally, medical files were evaluated for demographic data, American Society of Anesthesiologists score (I-IV), name of the surgeon, duration and indication for surgery, history of previous gynecological procedures and concomitant surgical interventions, weight of removed uterine tissue, duration of postoperative hospitalization in patients with complications, intraoperative conversion from laparoscopy to laparotomy, and malignancy rate. RESULTS: The mean age was 47.0 ± 7.3 years and mean body mass index was 25.6 ± 7.1 kg/m2 . Average parity was 1.04 ± 1.57. Average uterus weight was 761.8 ± 317.9 g (500-4065 g). The mean duration of surgery was 96.9 ± 49.5 min; 54% of all patients were treated without concomitant intervention, conversion rate was 2.12%. The malignancy rate was 0.4% and the complication rate was 6.81% with 1.36% intraoperative complications and 5.45% postoperative complications. CONCLUSIONS: The overall low complication and malignancy rates observed in this study allow us to present LASH as a safe and efficient alternative laparoscopic approach to remove uteri of any size in the hands of experienced surgeons.

The Laparoscopic-Assisted Combined Hysterectomy: A New Surgical Concept Compared to the Classical Laparoscopic-Assisted Vaginal Hysterectomy by a Prospective Study.

BACKGROUND AND AIMS: This controlled trial with II-1 evidence compared the safety and efficacy of the new laparoscopic-assisted combined hysterectomy (LACH) with the standard surgical technique laparoscopic-assisted vaginal hysterectomy (LAVH) in general and in patients displaying risk factors (large uterus, vaginal nulliparity, prior caesarean section). METHODS: From June 2007 to September 2008, 101 patients underwent a hysterectomy at the Clinic of Gynaecology, Obstetrics and Gynaecological Oncology at the Pius Hospital, University Hospital for Gynaecology in Oldenburg. The main outcome measures were feasibility, postoperative analgesia, postoperative inflammatory reaction, and duration of surgery. Statistical analyses were performed using SPSS for Windows (p < 0.05). RESULTS: We observed no significant differences between LACH and LAVH regarding outcome parameters or when risk factors were considered. Within the LACH group, the duration of surgery was significantly shorter for patients with UW <400 g. Still within the normal range, caesarean sections from both groups revealed significant differences in the number of leucocytes on the 2nd post-operative day. No urinary tract injuries, no unplanned conversion to laparotomy, no severe perioperative complications occurred in either group. CONCLUSION: In terms of technical feasibility, LACH represents a safe alternative for abdominal HE when LAVH is contraindicated.

Malignancy rate of 10,731 uteri morcellated during laparoscopic supracervical hysterectomy (LASH).

PURPOSE: This study aims to evaluate the number of cases of occult uterine malignancies in all LASH surgeries at the MIC clinic (Berlin) and to verify how the operative technique affects the prognosis of the disease. METHODS: Data of 10,731 patients who underwent a standardized LASH surgery with electric power morcellation between 1998 and April 30, 2014 were retrospectively analyzed. Main indication for LASH was symptomatic uterine myomas (81.3 %). RESULTS: No intra-operative complication was caused by use of a morcellator. In total, six sarcomas (0.06 %), including four endometrial stromal sarcomas (0.04 %) two leiomyosarcomas (0.02 %), and eight endometrial cancers (0.07 %) were documented. This amounts to a very low uterine malignancy rate of 0.13 %. Median follow-up period for all six patients with sarcoma and seven patients with endometrial cancer was 65.58 months (13-169). No recurrence was reported for the patients with endometrial cancer and five sarcoma patients in the comprehensible follow-up period. One patient died 13 months after LASH surgery due to the diagnosed leiomyosarcoma with peritoneal carcinomatosis and bone metastases. CONCLUSION: In 10,731 morcellated uteri during LASH only 0.06 % sarcoma and 0.07 % endometrial carcinoma were detected. All patients should be informed about the rare possibility of a malignant disease during pre-operative counseling. With a timely follow-up surgery according to the oncologic guidelines, our data suggest a very good prognosis in terms of survival after LASH with morcellation of malignant tumors in the uterus.

Evaluation of SprayShield™ Adhesion Barrier in a single center: randomized controlled study in 15 women undergoing reconstructive surgery after laparoscopic myomectomy.

OBJECTIVE: The objective of this study was to evaluate the safety and efficacy of SprayShield™ Adhesion Barrier in preventing and/or reducing postoperative adhesion during gynecological surgery. DESIGN: This was a prospective, controlled, blinded, and randomized study. Patient blinding was performed intraoperatively. Subjects were randomly assigned to the SprayShield™ or the control group in a 2:1 ratio. SETTING: The study was conducted at the Clinic of Gynaecology and Obstetrics, at the University Hospital for Gynecology in Germany. PATIENTS: Fifteen patients participated in this study; nine patients were assigned to the SprayShield™ and six patients to the control group. INTERVENTIONS: During first operation (FLL) in the SprayShield™ group, the agent was applied to all myomectomy suture lines. Patients in the control group did not receive any anti-adhesion treatment, only good surgical practice. A second-look laparoscopy (SLL) was performed 8-12 weeks after myomectomy to evaluate adhesion formation. MAIN OUTCOME MEASURES: Main outcome measures were incidence, severity, and extent of uterine adhesions. RESULTS: No significant differences were found between the two study groups. CONCLUSIONS: SprayShield™ is easy to use. No serious adverse event related to SprayShield™ was observed. Efficacy data are inconclusive regarding the performance of SprayShield™. Further studies are needed to better understand this performance.

Reducing trocar movement in operative laparoscopy through use of a fixator.

STUDY OBJECTIVE: To evaluate trocar stability using a fixation device to control trocar insertion depth and in particular to provide greater stability during laparoscopic procedures, and to evaluate the effects of using a fixator to control mobility of trocars. DESIGN: Non-blinded prospective study (Canadian Task Force classification II-2). SETTING: University hospital department of gynecology, obstetrics, and gynecological oncology. PATIENTS: Forty-three patients scheduled to undergo gynecologic laparoscopic intervention with planned operative time >10 minutes. INTERVENTIONS: In all procedures, 5-mm working trocars bearing a plain (smooth) sleeve were used. The fixator device, consecutively either on the left or right side, was attached to 1 of 2 side trocars before insertion. In 18 patients, an unsutured fixator was used (FX-US subgroup). In the remaining 25 patients, the device was sutured to the skin via specially designed suturing ports (FX-S subgroup). The position of both trocars in the groups with a fixator (FX group) and without a fixator (NFX group) in the abdominal wall was evaluated at the start of the procedure and every 10 minutes intraoperatively. MEASUREMENTS AND MAIN RESULTS: In the FX group, there was significantly decreased trocar movement compared with the NFX group (mean [SD] 0.02 [0.6] cm vs 0.84 [4.4] cm). In addition, in the NFX group, the trocar tended to slip into the abdomen during the operation, whereas in the FX group, trocars tended to slip out. Of 43 ports, 11 (25.6%) had to be either reinserted or readjusted at some point during the operation. In 2 procedures, reinsertion of the trocar at exactly the same location was impossible. In the FX-US subgroup, there was 1 incidence of trocar dislocation, whereas there were no dislocations in the FX-S subgroup. The difference in the effect between the 2 study arms, fixator unsutured and fixator sutured, was expected to produce only a small benefit in the sutured fixator arm; however, the benefit was greater than anticipated. CONCLUSION: Use of a fixator significantly reduces plain (smooth) sleeve trocar movement and prohibits complete dislocation or slippage of the port, and suturing the device to the skin further minimizes trocar movement. Trocar stabilization via a fixation device may lead to shorter operative time and reduce problems associated with trocar slippage or dislocation.

Postoperative patient satisfaction after laparoscopic supracervical hysterectomy.

BACKGROUND AND OBJECTIVES: The aim of this study was to evaluate postoperative patient satisfaction in women after laparoscopic supracervical hysterectomy (LASH). METHODS: A retrospective study by a mailed questionnaire among 2334 women who underwent hysterectomy via LASH at the MIC-Klinik, Berlin, between 1998 and 2004 was conducted. Indications for LASH were uterus myomatosus, adenomyosis uteri, disorders of bleeding, and genital descensus. The LASH operation technique was standardized and remained consistent throughout the observation period. Pearson's test for metric variables, Spearman's rank correlation test for ordinal data, Mann-Whitney U test, and Kruskal-Wallis test were used. RESULTS: Of the 2334 questionnaires mailed, 1553 were returned and 1431 (61.3%) of those could be analyzed. Almost 94% (93.9%) of the women were highly satisfied with the outcome, 5.6% reported medium satisfaction, and 0.5% were not satisfied. There was no significant difference in patient satisfaction with regard to the different indication for LASH. CONCLUSION: This study demonstrates high postoperative patient satisfaction after LASH. The rate of highly satisfied women might be increased by carefully choosing the right indications for LASH and improving operation techniques. This is important for widening acceptance of this innovative new operation standard.

A review of the problematic adhesion prophylaxis in gynaecological surgery.

BACKGROUND: Adhesions lead to considerable patient morbidity and are a mounting burden on surgeons and the health care system alike. Although adhesion formation is the most frequent complication in abdominal and pelvic surgery, many surgeons are still not aware of the extent of the problem. To provide the best care for their patients, surgeons should consistently inform themselves of anti-adhesion strategies and include these methods in their daily routine. METHODS: Searches were conducted in PubMed and The Cochrane Library to identify relevant literature. FINDINGS: Various complications are associated with adhesion formation, including small bowel obstruction, infertility and chronic pelvic pain. Increasingly, an understanding of adhesion formation as a complex process influenced by many different factors has led to various conceivable anti-adhesion strategies. At present, a number of different anti-adhesion agents are available. Although some agents have proved effective in reducing adhesion formation in randomised controlled trials, none of them can completely prevent adhesion formation. CONCLUSION: To fulfil our duty to provide best possible care for our patients, it is now time to regard adhesions as the most common complication in surgery. Further research is needed to fully understand adhesion formation and to develop new strategies for adhesion prevention. Large clinical efficacy trials of anti-adhesion agents will make it easier for surgeons to decide which agent to use in daily routine.

Laparoscopic sacropexy: a retrospective analysis of perioperative complications and anatomical outcomes.

BACKGROUND AND OBJECTIVE: The aim of this study was to evaluate the surgical outcomes and complications of laparoscopic sacropexy with regard to 3 varying mesh attachment points: the vaginal stump, the cervical stump, and the posterior side of the cervix in the case of uterus preservation. METHOD: A retrospective study was conducted among 310 women treated for descensus with laparoscopic sacropexy between January 2000 and December 2007. Information was obtained from medical files and follow-up examinations. RESULTS: Sacropexies with mesh attachment to the cervical stump, to the vaginal stump, and with uterus preservation were performed in 213, 67, and 30 cases, respectively. In 40 cases, no concomitant interventions were necessary. One perioperative conversion and 2 terminations occurred. Short-term complications included fever in 15 cases and urinary incontinence in 7 cases. Average follow-up was 7.9 mo with 211 patients completing followup. Prolapse recurrence rate was 10.4%; the reoperation rate was 4%. No significant differences between groups were detected for cystocele recurrence. Rectocele recurrence was significantly higher (P < .05) for sacropexy with vaginal mesh attachment. A reduction of incontinence was observed, which was significant (P < .05) for those patients treated with simultaneous or previous hysterectomy. CONCLUSION: Laparoscopic sacropexy shows good short-term results with low reprolapse and complication rates.

Prophylactic Salpingectomy during Hysterectomy for Benign Disease: A Prospective Study to Evaluate High-Grade Serous Ovarian Carcinoma Precursors.

Recent findings suggest that high-grade serous ovarian cancer can originate in the fallopian tube. Not only has that made the identification of precursor lesions pivotal in early detection and prevention of these cancers, prophylactic salpingectomy alongside hysterectomy for benign indications has been increasingly proposed as well. The present prospective single-center study included 273 women who underwent opportunistic salpingectomy alongside laparoscopic supracervical hysterectomy. Uterine and tubal histopathological results as well as intra- and postoperative complications were evaluated. The complication rate was 3.3%, of which none were caused by salpingectomy. Uterine histopathology diagnosed 181 patients (66.8%) with uterine myomas, 60 patients (22.1%) with adenomyosis, 29 patients (10.7%) with adenomyomatosis, and, 1 patient (0.4%) without pathological abnormality. p53 signatures were detected in 221 right fallopian tubes (80.9%) and in 229 left tubes (83.9%). In total, 8 patients showed bilateral STIL (2.9%), whereas in 1 patient (0.4%) STIL was detected in the left tube only. No STIC were detected. Laparoscopic opportunistic salpingectomy is demonstrated to be both safe and feasible. It appears to be promising to reduce the risk for ovarian cancer, yet more studies are needed to undoubtedly confirm this.

Laparoscopic myomectomy in patients with uterine myomas associated with infertility.

Although myomectomy is widely accepted in women of childbearing age who wish to retain their fertility, the extent to which myomas affect fertility and whether their removal improves this remain unclear. This study aimed to elucidate the favourable surgical approach in women with uterine myomas and infertility. This retrospective, follow-up study was carried out in three centres in Germany. Data on women who had undergone myomectomy via laparoscopy, laparotomy or conversion to laparotomy in 2000-04 were collected and analysed. Fertility outcome after myomectomy was assessed by follow-up postal questionnaire in a subgroup of women with myoma-associated infertility. Data on 159 women with otherwise unexplained infertility were included (mean age 35 years (range 17-47), mean number of myomas 2.4 (range 1-8) and mean myoma size 6.1 cm (range 0.5-20)). Women who underwent laparoscopy had fewer complications. 39.6% (63/159) of women completed the questionnaire, which showed that the pregnancy rate after myomectomy was 46% in this group. No uterine rupture occurred. Laparoscopy is associated with fewer postoperative complications and since no preoperative or intraoperative factors seem to influence the fertility outcome in women with uterine myomas, it is the treatment of choice in these patients.

Saving time during laparoscopy using a new, wall anchoring trocar device.

OBJECTIVE: Safe and reliable access systems are crucial in laparoscopy, and trocar dislodgement is still a common and frustrating problem. Wall emphysema can occur besides the risky prolongation of the surgical procedure. Wall-anchoring components provide a better hold of the device. This comparative analysis assesses the frequency of dislodgement and a time-sparing effect on the intervention of 3 different trocar systems, including an innovation in the field of access-providing systems. METHODS: Patients who underwent laparoscopy for various gynecological indications were included and randomized consecutively into 3 groups according to the access system used in the intervention: (A) trocar fitted with a spiral thread on the sleeve, (B) trocar with plain sleeve, (C) trocar as in B together with a fixator. This novelty is installed on the trocar before insertion and then sutured to the abdominal wall. Intervention time, frequency of trocar corrections, and the time loss through correction were registered. Standard statistical analyses were performed. RESULTS: The cohort comprised 131 patients; 51 patients were consecutively randomized into group A, 38 into group B, and 42 into group C. Mean intervention time was different, shortest in C and highest in B. Frequency of interruption of the intervention due to adjustment of the device and time loss through adjustment was lowest in group C (fixator + plain sleeve) and highest in group B (plain-sleeve) (0.47 vs 0.29, P<0.05 and 2.13 minutes vs 0.69 minutes, P<0.05). CONCLUSION: Wall-anchoring components lead to higher stability of ports and have a time-sparing effect. Comparing the 2 trocar groups with wall-anchoring properties (trocar with thread-fitted sleeve vs fixator + trocar with plain sleeve), the mean operation time was lowest in the fixator group, and the time-saving effect was higher.

DNA damage induced by cis- and carboplatin as indicator for in vitro sensitivity of ovarian carcinoma cells.

BACKGROUND: The DNA damage by platinum cytostatics is thought to be the main cause of their cytotoxicity. Therefore the measurement of the DNA damage induced by cis- and carboplatin should reflect the sensitivity of cancer cells toward the platinum chemotherapeutics. METHODS: DNA damage induced by cis- and carboplatin in primary cells of ovarian carcinomas was determined by the alkaline comet assay. In parallel, the reduction of cell viability was measured by the fluorescein diacetate (FDA) hydrolysis assay. RESULTS: While in the comet assay the isolated cells showed a high degree of DNA damage after a 24 h treatment, cell viability revealed no cytotoxicity after that incubation time. The individual sensitivities to DNA damage of 12 tumour biopsies differed up to a factor of about 3. DNA damage after a one day treatment with cis- or carboplatin correlated well with the cytotoxic effects after a 7 day treatment (r = 0,942 for cisplatin r = 0.971 for carboplatin). In contrast to the platinum compounds the correlation of DNA damage and cytotoxicity induced by adriamycin was low (r = 0,692), or did not exist for gemcitabine. CONCLUSION: The measurement of DNA damage induced by cis- and carboplatin is an accurate method to determine the in vitro chemosensitivity of ovarian cancer cells towards these cytostatics, because of its quickness, sensitivity, and low cell number needed.

Laparoscopic supracervical hysterectomy: a retrospective analysis of 1000 cases.

OBJECTIVE: Laparoscopic supracervical hysterectomy (LASH) was analyzed with regard to surgical indications and outcomes. METHODS: This is a retrospective analysis of the first 1,000 consecutive laparoscopic supracervical hysterectomies performed by one gynecologist from September 1, 2002 to April 30, 2006. The objective of the study was to find out to what extent the indication and the outcome of surgery changed with the increase in experience of the surgeon and whether a learning curve could be established based on the results. The demographic patient data, indication for surgery, patient history with regard to previous surgery, duration of surgery, intraoperative complications, uterus weight, and length of in-patient stay were collected from the medical records. RESULTS: The main indication in 80.4% of cases was uterus myomatosis. The median duration of surgery was 70.9+/-26.3 minutes (95% CI, 69.2 to 72.5) with an average uterus weight of 212.5+/-177.0g (95% CI, 201 to 223.6). This was reduced from 85.4+/-25.9 minutes (95% CI, 78.5 to 92.3) in 2002 to 72.4+/-30.1 minutes (95% CI, 66.7 to 78.2) in 2006, in conjunction with an increase in average uterus weight from 192.3+/-145.4g (95% CI, 153.8 to 230.9) to 228.7+/-160.3g (95% CI, 198.1 to 259.3). Overall, one intraoperative lesion of the bladder (0.1%) occurred, and in 4 cases the surgeon had to convert to laparotomy instead, due to the size and immobility of the uterus. Sixty-eight patients had a uterus weight of more than 500 g. In 67% of the cases, surgery was performed on patients with at least one previous laparotomy, and 51.4% of the patients required further interventions. CONCLUSION: An experienced surgeon can rapidly learn the technique of laparoscopic supracervical hysterectomy and can safely perform it. In patients with symptomatic uterine myomatosis, previous laparotomy and/or with a uterine weight of more than 500g, laparoscopic supracervical hysterectomy is a useful alternative to total hysterectomy. There are few complications if preservation of the cervix is not contraindicated.

Occult Malignancy Rate of 1498 Hysterectomies or Myomectomies with Morcellation: A Retrospective Single-Arm Study.

BACKGROUND AND PURPOSE: Since April 2014, the FDA warns against the use of morcellation during minimally invasive uterine surgery because of the risk of occult malignant spreading in the abdominal cavity. It is clear, however, that more studies are needed to define the incidence of occult uterine cancers, its risk factors, preoperative identification and postoperative follow-up. The present retrospective single-arm study defines the prevalence of occult uterine malignancies in a large group of patients treated with hysterectomy or myomectomy for benign indications. METHODS: In the year of 2014, 1498 women admitted for a myomectomy or hysterectomy in benign conditions at the clinic of minimally invasive surgery (Minimal Invasive Chirurgie or MIC) in Berlin (Germany) were included in this study. The morcellated uterine specimens of operated patients were histologically analyzed for the presence of cancerous tissue. RESULTS: We detected malignancies in three of the 1498 women (0.2%): two patients had endometrial cancer, while we observed cervical cancer in situ in the third patient. No sarcoma was found. CONCLUSION: We detected a very low prevalence of occult uterine malignancy which is in line with several other recent studies. To define a clear policy on the use of morcellation, more studies are required. In the meantime, patients should be informed about the risks of morcellation in case of undetected cancer prior to surgery.

LASH in Severely Enlarged Uterine Leiomyoma: Removal of a Uterus of 4065 g.

Today, even though minimally invasive approaches have become standard worldwide, large uteri are still mainly removed by means of open abdominal approaches. The present case describes the successful removal of the largest uterus ever reported (4065 g) by means of laparoscopy-assisted supracervical hysterectomy (LASH). We combined LASH with the changeover technique which allows a better access and view. We further explain how this approach allows for the safe minimally invasive removal of uteri of any size.

Laparoscopic Ureteral Reimplantation in Endometriosis: A Severe Case.

In aggressive cases, endometriosis can perturb the urogenital tract, in particular the ureter, which can potentially result in ureteral compression or stenosis. Even though this is rare, consequences are dramatic, such as hydronephrosis or organ failure. The present standard intervention comprises the resection of affected tissues and endometriosis foci combined with adjuvant hormonal therapy. When the ureter does not recover, ureteral reimplantation is required. The present case describes the successful laparoscopic approach of the reimplantation of the ureter with simultaneous cystoscopy.

Long term follow-up concerning safety and efficacy of novel adhesion prophylactic agent for laparoscopic myomectomy in the prospective randomized ADBEE study.

We conducted a prospective randomized single blind - subject study in the University Clinic of Gynecology of Pius-Hospital Oldenburg. The primary objective of the ADBEE study was to assess the safety and manageability of ADBLOCK when used as an adjunct to laparoscopic surgery for the primary of myomas in women wishing to improve pregnancy outcomes. The study population included 32 women aged between 18-45 years, in good general health condition, who have not completed their family planning and who are undergoing primary ('virgin') laparoscopic myomectomy with an aim to improve pregnancy outcomes. The patients were randomized in 2 groups, ADBLOCK arm with 21 patients and surgery only arm with 11 patients. The study was single blind - subject and the investigators were blinded to treatment group assignment until completion of uterine suturing and prior to removal of the endoscope. A vigorous follow-up of subjects was organized, focusing on its two critical characteristics: completeness and duration. Completeness represented the percentage of subjects who returned to every planed follow - up appointments. The patients were evaluated in a specific period of time, which defined the duration of follow-up. Safety of the ADBLOCK was estimated after analyzing and documentation of any adverse events occurred, clinical and physical examination of patients as well as evaluation of laboratory measures. There were 25 adverse events reported in ADBLOCK treatment group and 12 events in NO-ADBLOCK group over the 24-months treatment. All adverse events in both treatment arms were not anticipated, with all events in the ADBLOCK group being resolved. At 28 days, there was no significant difference in proportion of events between the two treatments (p = 0.440). Overall, the number of events reported was low and the severity of events was generally mild with an unlikely or no relationship to treatment. There were no unanticipated device related adverse events seen in both treatment groups over the immediate post-operative period or during the 24 months follow up period. By 12 weeks all patients reported their wound as healing well or healed and at 6 months all wounds were reported as healed. There were no differences between both treatment groups regarding the use of painkillers over 24 months follow up period. This clinical first - in - human study, sustained by a rigorous follow-up of the subjects has demonstrated that ADBLOCK is a safe product, presenting no additional safety risk or burden to the patients over surgery alone. The device was relatively easy to use, with a low device failure rate that had no impact on the surgical procedures.

How to avoid risks for patients in minimal-access trials: Avoiding complications in clinical first-in-human studies by example of the ADBEE study.

A clinical trial is a prospective study designed to establish the safety and efficacy of investigational devices in humans, in accordance with the strict guidelines of the Food and Drug Administration (FDA; USA) or European Medicines Agency (EMA; Europe). Before a clinical first-in-human study is initiated, preclinical studies of the investigational product are mandatory, and the results should be sufficient to indicate that the investigational device is acceptably safe for the proposed evaluation in human subjects. The present paper describes an experience of clinical trials, highlighting ways of avoiding possible complications in clinical first-in-human studies. For a better approach to our aim, we exemplified a prospective, randomized, single-blind study, ADBEE. The primary objective was to assess the safety of the ADBLOCK system when used as an adjunct to laparoscopic primary removal of myomas in women wishing to improve pregnancy outcomes.

Reconstructive laparoscopic prolapse surgery to avoid mesh erosions.

INTRODUCTION: The objective of the study is to examine the efficacy of the purely laparoscopic reconstructive management of cystocele and rectocele with mesh, to avoid the risk of erosion by the graft material, a well known complication in vaginal mesh surgery. MATERIAL AND METHODS: We performed a prospective, single-case, non-randomized study in 325 patients who received laparoscopic reconstructive management of pelvic organe prolaps with mesh. The study was conducted between January 2004 and December 2012 in a private clinic in India. The most common prolapse symptoms were reducible vaginal lump, urinary stress incontinence, constipation and flatus incontinence, sexual dysfunction and dypareunia. The degree e of the prolaps was staged according to POPQ system. The approach was purely laparoscopic and involved the use of polypropylene (Prolene) or polyurethane with activated regenerated cellulose coating (Parietex) mesh. RESULTS: The mean age was 55 (30-80) years and the most of the patients were multiparous (272/325). The patients received a plastic correction of the rectocele only (138 cases), a cystocele and rectocele (187 cases) with mesh. 132 patients had a concomitant total hysterectomy; in 2 cases a laparoscopic supracervical hysterectomy was performed and 190 patients had a laparoscopic colposuspension. The mean operation time was 82.2 (60-210) minutes. The mean follow up was 3.4 (3-5) years. Urinary retention developed in 1 case, which required a new laparoscopical intervention. Bladder injury, observed in the same case was in one session closed with absorbable suture. There were four recurrences of the rectocele, receiving a posterior vaginal colporrhaphy. Erosions of the mesh were not reported or documented. CONCLUSION: The pure laparoscopic reconstructive management of the cystocele and rectocele with mesh seems to be a safe and effective surgical procedure potentially avoiding the risk of mesh erosions.