Prospective International Multicenter Pelvic Floor Study:Short-Term Follow-Up and Clinical Findings for Combined Pectopexy and Native Tissue Repair

Efforts to use traditional native tissue strategies and reduce the use of meshes have been made in several countries. Combining native tissue repair with sufficient mesh applied apical repair might provide a means of effective treatment. The study group did perform and publish a randomized trial focusing on the combination of traditional native tissue repair with pectopexy or sacrocolpopexy and observed no severe or hitherto unknown risks for patients (Noé G.K. J Endourol 2015;29(2):210–215). The short-term follow-up of this international multicenter study carried out now is presented in this article. Material and Methods: Eleven clinics and 13 surgeons in four European counties participated in the trial. In order to ensure a standardized approach and obtain comparable data, all surgeons were obliged to follow a standardized approach for pectopexy, focusing on the area of fixation and the use of a prefabricated mesh (PVDF PRP 3 × 15 Dynamesh). The mesh was solely used for apical repair. All other clinically relevant defects were treated with native tissue repair. Colposuspension or TVT were used for the treatment of incontinence. Data were collected independently for 14 months on a secured server; 501 surgeries were registered and evaluated. Two hundred and sixty-four patients out of 479 (55.1%) returned for the physical examination and interview after 12–18 months. Main Outcome and Results: The mean duration of follow-up was 15 months. The overall success of apical repair was rated positively by 96.9%, and the satisfaction score was rated positively by 95.5%. A positive general recommendation was expressed by 95.1% of patients. Pelvic pressure was reduced in 95.2%, pain in 98.0%, and urgency in 86.0% of patients. No major complications, mesh exposure, or mesh complication occurred during the follow-up period. Conclusion: In clinical routine, pectopexy and concomitant surgery, mainly using native tissue approaches, resulted in high satisfaction rates and favorable clinical findings. The procedure may also be recommended for use by general urogynecological practitioners with experience in laparoscopy

Depth of Neuromuscular Block Is Not Associated with Abdominal Wall Distention or Surgical Conditions during Gynecologic Laparoscopic Operations. A Prospective Trial

The influence of the degree of a neuromuscular block (NMB) on surgical operating conditions during laparoscopic surgery is debated controversially. The extent of abdominal distension during the time course of the NMB was assessed as a new measurement tool. In 60 patients scheduled for gynecologic laparoscopic surgery, the increase of the abdominal wall length induced by the capnoperitoneum was measured at 5 degrees of the NMB: intense NMB-post-tetanic count (PTC) = 0; deep NMB-train-of-four count (TOF) = 0 and PTC = 1-5; medium NMB-PTC > 5 and TOF = 0-1; shallow NMB-TOF > 1; full recovery-train-of-four ratio TOFR > 90%. Simultaneously, the quality of operating conditions was assessed with a standardized rating scale (SRS) reaching from 1 (extremely poor conditions) to 5 (excellent conditions). Fifty patients could be included in the analysis. The abdominal wall length increased by 10-13 mm induced by the capnoperitoneum. SRS was higher during intense NMB (4.7 +/- 0.5) vs. full recovery (4.5 +/- 0.5) (mean +/- SD; p = 0.025). Generally, an intense NMB did not increase abdominal wall length induced by capnoperitoneum. Additionally, its influence on the quality of surgical operating conditions seems to be of minor clinical relevance

Pain Medication Requirements After Sacropexy and Combination Interventions

Background and Objectives: Laparoscopic surgery is associated with reduced morbidity, and postoperative pain is reduced. The aim of this study was to assess postoperative pain intensity, analgesic requirements, and the influence of cofactors after laparoscopic sacral colpopexy. Methods: The study assessed 287 patients treated with laparoscopic sacropexy for genital prolapse with a Pelvic Organ Prolapse Quantification grade >1. Patients were asked to evaluate their pain postoperatively using a 4-point verbal pain rating scale. In addition, medical records were analyzed regarding the requirement for analgesic medication. Results: Patients distinguished between abdominal pain and shoulder pain after laparoscopy. Abdominal pain reached maximum severity on day 1 and showed a good response to nonsteroidal antiphlogistics, whereas shoulder pain was rarely found (6.27%). Of the patients, 38% required no pain treatment or required 1 dose at most. The need for pain medication reached its climax on day 1 and decreased during the 5 following days. Non-opioid analgesics provided a sufficient therapeutic effect. Conclusion: Laparoscopic sacropexy is associated with a moderate degree of postoperative pain. Non-opioid analgesics should be preferred as first-line therapy. The typical shoulder-tip pain showed only a low prevalence in our study group. From our point of view, the low rate of shoulder-tip pain corresponded with the low intra-abdominal carbon dioxide pressure

Value of Clinical and Laboratory Inflammation Factors in the Postoperative Period after Laparoscopic Urogynecological Surgery

Background/Aims: Leukocytes and C-reactive protein (CRP) levels are often used to detect infections. The aim of this study was to evaluate the diagnostic and screening validity of leukocytes and CRP levels as well as body temperature >38 degrees C to predict infections after laparoscopic sacrocolpopexy. Methods: The study included 287 patients suffering from genital prolapse higher than POP-Q I. In addition to the sacrocolpopexy, a laparoscopic supracervical hysterectomy was performed in cases of preexisting uterus (n = 171). Leukocytes and CRP levels were analyzed preoperatively and 4 days after surgery. Early and late onset of infections was documented. Results: Urinary tract infection was identified as the most frequent early postoperative complication (11.4%). Early wound infections were found in 2.8% of the patients (8/287). Late onset of infections was found in 1% of patients (3/287). Areas under ROC curves were low for both leukocytes (0.52, 95% CI: 0.37-0.66) and CRP levels (0.60, 95% CI: 0.44-0.77). Conclusion: Our findings question the benefit of routine determination of leukocytes and CRP levels 4 days after surgery. The sensitivity and specificity of leukocytes and CRP levels are probably more significant after normalization of the initial tissue response (days 8-10). (C) 2014 S. Karger AG, Base

Value of indocyanine green pelvic lymph node mapping in the surgical approach of cervical cancer

Purpose Lymph node metastasis is a significant predictive factor for disease recurrence and survival in cervical cancer patients and relevant for therapeutic strategies. We evaluated the clinical value of indocyanine green (ICG) by measuring the sensitivity and negative predictive value of sentinel lymph node mapping compared with the gold standard of complete lymphadenectomy in detecting lymph node metastases for cervical cancer. Methods We utilized the near-infrared imaging agent ICG to detect tumor-infested lymph nodes in the pelvis analogue to a classical sentinel lymph node procedure by analyzing data from 20 patients who had undergone surgery for cervical cancer at our institution. A laparoscopic lymph node mapping procedure by means of ICG, followed by a complete pelvic lymphadenectomy with or without paraaortic lymphadenectomy was done in all patients. Results Histological examination identified seven patients with tumor-positive pelvic nodes, whereas mapping with ICG identified only five of these patients. Detection rate of positive nodes by ICG mapping and false negative rate was 71.4% and 28.6%, respectively; bilateral detection rate was 83.3%. One of the two false negative patients additionally suffered from deep infiltrating endometriosis. Conclusions Our results indicate that ICG can identify the relevant pelvic nodes independent of tumor size, provided bilateral detection is achieved and additional, related diseases are excluded

Laparoscopic versus vaginal native tissue repair in combination with pectopexy. Sub-analysis from an international, prospective, and multi-centre study: short term results

Introduction The use of mesh for vaginal repairs is currently problematic and as a consequence, there is increased interest in native tissue repair. We describe the follow-up data of a sub-analysis of a prospective and multi-center study focusing on the combination of pectopexy and native tissue repair. Patients were followed up for 12-18 months after surgery (+ SD: 15). Two-hundred and sixty-four patients attended the clinics for physical examination and were integrated into the follow-up. Cystocele repair was performed laparoscopically in 84 patients and vaginally in 52 patients. Posterior repair was performed vaginally in 40 patients and laparoscopically in 53 patients. Results: Clinical success rate, patient recommendations and patient satisfaction rates were similar in both groups. The laparoscopic anterior repair resulted in an 89% cure or anatomical improvement rate; this compared to 94.2% for the vaginal approach. In the posterior group, laparoscopy resulted in a 94.3% cure or improvement rate compared to 97.5% in the second group. Conclusions: The outcomes of both strategies showed satisfactory results in our study. Consequently, surgeons may choose between the two strategies according to their preference and skill. The two approaches only differed with regard to vaginal scarring. We suggest future research investigating the long-term impact of scarring

Impact of nodal status and treatment strategy on overall survival in advanced stage cervical cancer

PurposeThe lack of prognostic data impedes implementation of optimal therapy for cervical cancer. For instance, recommended therapy for FIGO IIB cervical cancer is radical hysterectomy or radiochemotherapy. To enlighten different therapeutic approaches, we investigated the benefit of individual therapies or combination thereof in patients with or without infested lymph nodes.MethodsThe German Tumor Centre Regensburg registered 389 patients with FIGO IIB, IIIA, IIIB, and IVA cervical cancer between 2002 and 2015. We estimated hazard ratios (HR) for overall survival against different therapies using univariable and multivariable cox regression. After risk adjustment with respect to clinicopathological parameters, we performed model selection using conditional stepwise reverse selection.ResultsWe demonstrated the need for thorough assessment of the nodal status to obtain reliable data for treatment strategy. Our analysis showed significant differences for overall survival in FIGO IIB depending on therapy and nodal status. Outcome was inferior with radiochemotherapy without surgery for patients with N0 compared to surgery and radiochemotherapy combined (HR 3.012; 95% CI 1.075-8.441; p=0.036); however, for N1, radiochemotherapy without surgery resulted in comparable outcome (HR 0.808; 95% CI 0.189-3.403; p=0.765), whereas surgery alone yielded in poor outcome (HR 2.889; 95% CI 1.356-6.156; p=0.006). Regardless of the nodal status, chemotherapy was superior in advanced stage cervical cancer FIGO III to IVA.ConclusionsOur study suggests that in terms of oncological outcome FIGO IIB cervical cancer patients benefit from a combination of surgery and radiochemotherapy. However, in the presence of lymph node infestation, surgery does not add substantial benefit to the patient

Is there a benefit for adjuvant radio(chemo)therapy in early cervical cancer? Results from a population-based study

Purpose Due to insufficient and conflicting prospective evidence, the recommendations on when to apply adjuvant radiochemotherapy in early-stage cervical cancer vary between international guidelines. In this population-based study, we evaluated the outcome of patients with early-stage cervical cancer based on risk factors and the adjuvant therapy they received. Methods The effect of primary therapy (surgery and radiochemotherapy RCT, surgery and radiotherapy RT, and surgery alone) on overall survival (OS) and recurrence-free survival (RFS) was evaluated in the complete cohort of 442 patients and in subgroups according to risk profile and nodal status. Results In low-risk patients, there was no difference in OS (p = 0.276) depending on whether patients received adjuvant therapy or not. Concerning RFS, patients with RT (including one patient with RCT) exhibited a significantly worse outcome compared to the group with surgery alone (p = 0.015). In intermediate-risk patients, the administration of adjuvant RT significantly benefited RFS when compared to surgery only in multivariate analysis (p = 0.031). Concerning OS, no significant influence for adjuvant treatment could be seen (p = 0.354). Though trends towards better OS and RFS could be observed in patients of the high-risk group-both in RCT and RT groups compared to surgery alone-the effects did not prove to be significant. Conclusion Our study reaffirms the evidence against the use of adjuvant radio(chemo)therapy in low-risk early-stage cervical cancer. In intermediate-, and less pronounced in high-risk patients, however, it seems to be beneficial. The role of adjuvant radio(chemo)therapy in early cervical cancer should be further investigated in prospective randomized trials