Hysterectomy for Benign Uterine Disease.

BACKGROUND: Hysterectomy is the second most common operation in obstetrics and gynecology after Cesarean section. Until now, there has not been any German clinical guideline with recommendations concerning the indications for hysterectomy for benign uterine conditions, in consideration of the available uterus-preserving alternative treatments. METHODS: We systematically searched the Medline database in 2013, in 2014, and in December 2015, focusing on aggregate evidence, and assessed the retrieved literature. The guideline recommendations were developed by a consensus process with structured independent moderation. RESULTS: 30 systematic reviews and 8 randomized controlled trials were analyzed. Among the study patients treated with either hysterectomy (by any technique) or an organ-preserving alternative, at least 75-94% were satisfied with their treatment. Vaginal hysterectomy was associated with lower complication rates, shorter procedure duration, and more rapid recovery than abdominal hysterectomy and is therefore the preferred technique. If vaginal hysterectomy is not possible, a laparoscopic approach should be considered. Abdominal hysterectomy should be reserved for special indications. In 2012, the frequency of abdominal hysterectomy in Germany, Austria, and Switzerland was lower than elsewhere in the world, at 15.7% , 28.0% , and 23.9% , respectively. Uterus-preserving techniques were associated with higher reintervention rates compared to hysterectomy (11-36% vs 4-10% ). CONCLUSION: The main objective is to reduce the frequency of abdominal hysterectomy. Patients should be counseled and made aware of uterus-sparing alternatives to hysterectomy so that they are able to make informed decisions.

Electrosurgery in Gynecology - a Comparison of Available Instruments that Coagulate and Cut Tissue.

In the field of minimally invasive gynecology the use of electrosurgical or energy-based devices has become extremely important for rapid preparation and short reconvalescence. The instruments that are on the market vary regarding their technical characteristics, specifications, and handling. We provide an overview of selected instruments that are appropriate for gynecological laparoscopy and review possible indications and limitations.

Bipolar vessel sealing: instrument contamination and wear have little effect on seal quality and success in a porcine in vitro model.

PURPOSE: The aim of this study is to systematically investigate under standardized experimental conditions the effects of instrument contamination and wear on the quality of bipolar vessel sealing (BVS) achieved using a reusable instrument. METHODS: The study was designed as a prospective, randomized, and controlled in vitro study and conducted in an academic research environment. Reusable bipolar coagulation forceps (BiClamp® 200 C, ERBE Elektromedizin) were used to apply sealing pressures of 300-1,100 mN/mm(2) to 239 renal arteries from commercially slaughtered female pigs (Swabian-Hall Swine). Forceps jaws were coated with porcine blood, blood and collagen, or blood, collagen, and fat to simulate instrument contamination with biological material during surgery. Clinical wear was mimicked by sandpaper abrasion. The main outcome measures were seal success (resistance to 250 mmHg intraluminal pressure for 2 min) and seal stability (burst pressure). RESULTS: Sealing pressure had a significant impact, with 800 mN/mm(2) producing the best sealing results. Seal success increased with total energy applied to the tissue, a higher maximum temperature, and longer coagulation as indicated by desiccation time. Experimental contamination had no significant impact on seal success and only a limited effect on seal stability. Similarly, abrasive wear also had no significant effect on either seal quality or seal strength. CONCLUSIONS: The impact of bipolar forceps contamination and wear on seal success and quality was negligible in our in vitro model. To achieve high-quality seals, it is essential to use adequate sealing pressures. Our findings could have direct implications for the design and clinical handling of BVS instruments.

First trimester pregnancy volumes and subsequent small for gestational age fetuses.

OBJECTIVE: To examine whether in the first trimester, placental, gestational sac and fetal volumes are different in pregnancies that result in small for gestational age (SGA) compared to average for gestational age (AGA) neonates. METHODS: Case-control study comparing first trimester 3D volumes of the placenta, the fetus and the gestational sac between SGA and AGA pregnancies. 3D volumes were acquired for quality assurance and documentation. Pregnancy volumes were calculated by the virtual organ computer-aided analysis technique. Linear regression analysis was used to compute a normal range for the placental, gestational sac and fetal volume based on the crown rump length (CRL) in AGA pregnancies. Multiple regression analysis was used to examine significant influencing covariates. A Student's t test was used to compare the difference between the SGA and AGA group. RESULTS: The study population consisted of 19 first trimester pregnancies with subsequent SGA neonates and 105 control pregnancies. In the AGA group, all pregnancy volumes were significantly dependent on the CRL. After controlling the CRL effect, the placental, gestational sac and fetal volumes were not significantly different between the SGA and AGA group. CONCLUSION: First trimester 3D pregnancy volume measurements are not different in SGA or AGA pregnancies.

Laparoscopic supracervical hysterectomy using EnSeal vs standard bipolar coagulation technique: randomized controlled trial.

OBJECTIVE: To compare the EnSeal device with standard bipolar coagulation forceps in laparoscopic supracervical hysterectomy (LASH). DESIGN: Prospective, randomized, controlled trial (Canadian Task Force classification I). SETTING: University hospital. PATIENTS: One hundred sixty patients who underwent LASH. INTERVENTION: Eighty patients underwent LASH using the EnSeal device (experimental group), and 80 patients underwent LASH using standard bipolar coagulation forceps (control group) (www.clinicaltrials.gov; study identifier NCT01806012). MEASUREMENTS AND MAIN RESULTS: Mean (SD) total operative time was 78.18 (33.96) minutes in the experimental group and 86.30 (35.34) minutes in the control group (p = .03). Documented blood loss was <50 mL in 72 patients in the experimental group and 62 patients in the control group (p = .03), and was 50 to 100 mL in 8 patients in the experimental group and 18 patients in the control group (p < .001). Postoperative hospital stay was significantly shorter for patients in the experimental group compared with the control group: 2.01 (0.44) days vs 2.17 (0.47) days, respectively (p = .03). There was no difference in postoperative pain scores and complications between the two treatment groups. CONCLUSION: Total resection time was shorter in the experimental group, and the other investigated clinical parameters were not inferior in the experimental group compared with the control group. The results of the present study indicate that use of the EnSeal device is at least as reliable as the conventional electrocoagulation technique in LASH.

Position of the conus medullaris in fetuses with skeletal dysplasia.

OBJECTIVES: To examine whether reduced conus distance (CD) measurement may be a marker for impaired growth of the fetal trunk in fetuses with certain types of skeletal dysplasia. METHODS: Two hundred fifty-four normal cases and 24 pregnancies with skeletal dysplasia were included. The fetuses with skeletal dysplasia were subdivided into two groups based on the specific diagnosis: skeletal dysplasias with a short trunk and skeletal dysplasias with a normal size trunk. Linear regression analysis was used to examine the relationship of the CD measurement with the biparietal diameter. CD measurements in the two groups of fetuses with skeletal dysplasia were compared using z-scores. RESULTS: In fetuses with skeletal dysplasia and shortened trunk, the CD measurement was significantly smaller than in the normal population (mean z-score -3.7, p < 0.0001). CD measurements in fetuses with skeletal dysplasia but a normal trunk size were similar to the normal population (mean z-score -0.1, p = 0.997). CONCLUSIONS: Short CD is associated with certain types of skeletal dysplasia. As such, measuring the CD may be helpful in diagnosing these conditions.

Bipolar coagulation with the BiClamp forceps versus conventional suture ligation: a multicenter randomized controlled trial in 175 vaginal hysterectomy patients.

PURPOSE: To compare bipolar vessel sealing (BVS; BiClamp) versus conventional suture ligation in vaginal hysterectomy. METHODS: A multicenter, single-blind randomized controlled trial (RCT) was conducted at eight women's hospitals in Germany. One hundred and seventy-five patients with benign uterine disease underwent vaginal hysterectomy using BVS (n = 88) or conventional suture ligation (n = 87 controls). Data analysis was based on intention-to-treat. RESULTS: Postoperative pain (primary endpoint) was decreased in the BVS group, but not significantly. Intraoperative blood loss was significantly lower in this group, with <100 mL recorded in 79/88 versus 52/86 patients (P < 0.001). Hemoglobin decrease indicated non-significantly lower blood loss in the BVS group. Operating time was significantly shorter in the BVS group than in the controls (38.0 +/- 18.6 vs. 48.0 +/- 24.9 min; P = 0.001). On average, 7.8 sutures/operation were saved with bipolar coagulation (P < 0.0001). Ease of use ratings were significantly higher for BVS. Hospital stay was similar for both groups. Adverse event rates did not differ significantly. CONCLUSIONS: The BiClamp procedure proved superior or similar to conventional ligation, particularly with regard to intraoperative blood loss, operating time and postoperative pain, although statistical significance was not attained for postoperative pain. Moreover, BVS was easier to use and more cost effective.

Thermal conduction, compression, and electrical current--an evaluation of major parameters of electrosurgical vessel sealing in a porcine in vitro model.

Bipolar vessel sealing is pivotal in laparoscopic hemostasis. However, major coaptive desiccation parameters have yet to be investigated in detail. The current investigation aims to study the impact of compressive pressure, thermal conduction, and electrical current effects on seal quality in a randomized, controlled experimental trial in an in vitro porcine model of vessel sealing. A total of 106 porcine vessels were sealed with either bipolar current or thermal conduction. Compressive pressure on the sealing site and maximum temperature were varied and monitored. Additionally, the longitudinal vessel tension was measured. The burst pressure of the resulting seal was determined as an indicator of seal quality. In bipolar coaptation, seal quality depends on the compressive pressure applied to the coagulation site in both arteries and veins. The optimal pressure interval was around 270 mN/mm2 for arteries and 200 mN/mm2 for veins. Deviation from these optimal pressures towards low and high extremes led to significantly fewer successful seals. We also found that both maximum coaptation temperature and vessel shrinking correlated with the seal quality. This correlation was reciprocal in arteries and veins. Thermal conduction alone was less successful than sealing by bipolar current. Therefore, compressive pressure during coaptation determines the seal quality. Upper and lower pressure boundaries for safe coaptation exist for both arteries and veins. Vessel sealing by thermal conduction without electrical current effects is possible but represents a less effective method for coaptation. These findings have implications for the rational design of new electrosurgical instruments.

Neovagina creation in vaginal agenesis: development of a new laparoscopic Vecchietti-based procedure and optimized instruments in a prospective comparative interventional study in 101 patients.

OBJECTIVE: To improve the laparoscopic Vecchietti procedure and optimize instrumentation for treatment of congenital vaginal agenesis with a minimum of complications and optimal functional outcome, in comparison with the conventional laparoscopic Vecchietti procedure. DESIGN: Prospective comparative interventional study. SETTING: University hospital. PATIENT(S): One hundred one patients with congenital vaginal agenesis. INTERVENTION(S): The interventions compared were [1] a new laparoscopic, Vecchietti-based method using vaginoabdominal blunt perforation without vesicorectal tunneling and [2] the laparoscopic Vecchietti procedure. MAIN OUTCOME MEASURE(S): Duration of surgery and traction, functional results, surgical and technical complications. RESULT(S): Without tunneling and with new instruments, mean operative time was more than halved, from 113.0 to 47.5 minutes, with a significantly reduced complication rate for bladder lesions and no bowel lesions. Mean traction time was similarly reduced, from 11.7 to 4.8 days. No instrument-related complications were seen with our new instrument set. After 6 months, the longer neovagina of 10.6 cm that was achieved with the new method was still 2.5 cm longer than the conventional result. No patients needed lubricants or had sustained pain during intercourse. CONCLUSION(S): Our new method for neovagina creation resulted in shorter operation and traction times, better functional results, and fewer surgical complications and no technical ones. It is therefore a safer, shorter, more effective, and less traumatic procedure.

Intelligent, impedance-regulated, pulsed coagulation in a porcine renal artery model.

OBJECTIVE: To compare the efficacy of conventional pulsed coagulation (CPC) and newly developed intelligent, impedance-regulated, pulsed coagulation (IPC) in the sealing of porcine renal arteries. DESIGN: Prospective, randomized experimental study. SETTING: Isolated porcine artery model in an academic research environment. ANIMAL(S): Female Swabian Hall pigs. INTERVENTION(S): Renal arteries were harvested from Swabian pigs, flushed with saline, and sealed with bipolar open forceps by using high-frequency modulations of CPC (CPC-I: 800-ms pulse, 30-ms pause; CPC-II: 800-ms pulse, 300-ms pause) or IPC (self-regulation of the current flow to tissue impedance during thermal alteration). Additional vessels underwent multiple CPC. Burst pressure and seal failure were measured by increasing the pressure in the sealed arteries with saline infusion until rupture of the seal or the vessel wall. MAIN OUTCOME MEASURE(S): Mean burst pressure, number of instant and secondary seal failures, and relation of burst pressure to vessel diameter. RESULT(S): Mean burst pressure after IPC (585.5 +/- 56.8 mm Hg) was statistically significantly higher than that after CPC (CPC-I: 372.6 +/- 40.0 mm Hg; CPC-II: 334.2 +/- 44.2 mm Hg). Only 5.0% of the vessel seals after IPC, but 34.0% and 39.5% after CPC-I and CPC-II, showed instant or secondary seal failures, which also was a statistically significant difference. Seal quality after multiple CPC was comparable to that observed after the single IPC application (burst pressure, 597.3 +/- 60.1 [MCPC-I] mm Hg and 656.2 +/- 56.5 mm Hg [MCPC-II]; seal failure rate, 0). CONCLUSION(S): In an isolated porcine renal artery model, self-regulating modulation of energy-based vessel coagulation achieved superior thermal fusion of vascular tissue than did CPC. This promising novel technique should be analyzed further to determine its in vivo efficacy in long-term studies.

Persistent urinary retention after tension-free vaginal tape: a new surgical solution.

The most common post-operative problems seen with the tension-free vaginal tape (TVT) are voiding difficulties. A small subset of patients develops persistent urinary retention, often associated with vaginal pain and dyspareunia. We describe a surgical solution to these complications that involves cutting of the prolene sling just below the urethra and individualised prologation with an additional piece of prolene-mesh.