Prevention of blood transfusion with intravenous iron in gynecologic cancer patients receiving platinum-based chemotherapy

Objectives

To compare the efficacy of intravenous iron and oral iron for prevention of blood transfusions in gynecologic cancer patients receiving platinum-based chemotherapy.

Materials and methods

Sixty-four non anemic gynecologic cancer patients receiving adjuvant platinum-based chemotherapy were stratified and randomized according to baseline hemoglobin levels and chemotherapy regimen. The study group received 200 mg of intravenous iron sucrose immediately after each chemotherapy infusion. The control group received oral ferrous fumarate at a dose of 200 mg three times a day. Complete blood count was monitored before each chemotherapy infusion. Blood transfusions were given if hemoglobin level was below 10 mg/dl.

Results

There were 32 patients in each group. No significant differences in baseline hemoglobin levels and baseline characteristics were demonstrated between both groups. Nine patients (28.1%) in the study group and 18 patients (56.3%) in the control group required blood transfusion through 6 cycles of chemotherapy (p = 0.02). Fewer median number of total packed red cell units were required in the study group compared to the control group (0 and 0.5 unit, respectively, p = 0.04). Serious adverse events and hypersensitivity reactions were not reported. However, constipation was significantly higher in the control group (3.1% and 40.6%, p = < 0.001).

Conclusions

Intravenous iron is an effective, well-tolerated treatment for primary prevention of blood transfusions in gynecologic cancer patients receiving platinum-based chemotherapy, associated with less constipation than the oral formulation.     

A randomized controlled trial on the value of misoprostol for the treatment of retained placenta in a low-resource setting

Objective

To evaluate the efficacy and safety of misoprostol among patients with retained placenta in a low-resource setting.

Methods

A prospective, multicenter, randomized, double-blind, placebo-controlled trial was carried out in Tanzania between April 2008 and November 2011. It included patients who delivered at a gestational age of 28 weeks or more and had blood loss of 750 mL or less at 30 minutes after delivery. Sublingual misoprostol (800 μg) was compared with placebo as the primary treatment. Power analysis showed that 117 patients would be required to observe a reduction of 40% in the incidence of manual removal of the placenta (MRP; P = 0.05, 80% power), the primary outcome. The secondary outcomes were blood loss and number of blood transfusions.

Results

Interim analysis after recruitment of 95 patients showed that incidence of MRP, total blood loss, and incidence of blood transfusions were similar in the misoprostol (MRP, 40%; blood loss, 803 mL; blood transfusion, 15%) and placebo (MRP, 33%, blood loss 787 mL, blood transfusion, 23%) groups. The trial was stopped because continuation would not alter the interim conclusion that misoprostol was ineffective.

Conclusion

Treatment with misoprostol was found to have no clinically significant beneficial effect among women with retained placenta.Clinical Trial Registration: Current Controlled Trials ISRCTN16104753     

Integrating a complementary medicine consultation for women undergoing chemotherapy

Objective

To explore oncology healthcare providers’ (HCPs’) patterns of referral of women undergoing chemotherapy to a complementary medicine (CM) consultation integrated within a conventional oncology service.

Methods

Oncology HCPs used a structured referral system for referral to an integrative physician (IP) for CM consultation. Referral goals were in accordance with a specified list of quality-of-life (QOL) outcomes.

Results

In total, the study HCPs referred 282 female patients, of whom 238 (84.4%) underwent CM consultation by the study IP: 59 (24.8%) with gynecologic cancer and 179 (75.2%) with non-gynecologic cancer. Use of CM for cancer-related outcomes was significantly higher among referred patients with gynecologic cancer than those with non-gynecologic cancer (69.5% vs 46.9%; P = 0.003). Oncologists initiated most of the referrals in the gynecologic oncology group, whereas oncologic nurses referred most patients in the non-gynecologic oncology group. Among patients with gynecologic cancer, the correlation between HCP indication and patient expectation was high for gastrointestinal concerns (κ 0.41).

Conclusion

The integration of a structured and informed process of referral to CM consultation may enhance patient-centered care and QOL during chemotherapy.     

Validation of a venous thromboembolism risk assessment model in gynecologic oncology

Objectives

Gynecologic oncology patients undergoing surgery are at an increased risk for venous thromboembolism (VTE). We attempted to validate a VTE risk assessment model in gynecologic oncology patients.

Methods

All gynecologic oncology patients who underwent a laparotomy for the diagnosis or suspicion of gynecologic malignancy from 2004 to 2010 were included. Demographic, surgicopathologic, and complication data were collected. VTE was based on the symptomatic diagnosis. Data for the Caprini risk assessment model (RAM) was used to score and stratify patients on their risk for VTE.

Results

1123 gynecologic oncology patients were included within this study. Ovarian cancer was the most common diagnosis (39%) with a median age of 56.1. All patients received SCDs with 40% receiving double prophylaxis. The overall incidence of VTE was 3.3%, with lower extremity deep venous thrombosis (DVT) n = 17 and pulmonary embolism (PE) n = 20. Complication rates were similar in each group. Based on the Caprini scoring model 92% of patients scored in the “Highest Risk” category. The Caprini RAM accurately predicted all 37 VTEs, all of which scored in the “Highest Risk” category. The percentage of patients that received double prophylaxis increased with time from 12% in 2004 to 63% in 2010. Importantly, 25 of the 37 VTEs (68%) did not receive double prophylaxis.

Conclusions

The use of the Caprini RAM accurately predicted patients at the highest risk of experiencing VTE. Considering accurate identification of patients allows proper administration of double prophylaxis, we recommend the use of this scoring model preoperatively in patients undergoing surgery for gynecologic malignancies.     

Postoperative readmissions following ileostomy formation among patients with a gynecologic malignancy

Objectives

Ileostomy results in a relatively poorer water reabsorption and is associated with dehydration and renal injury. These problems may be exacerbated in the setting of gynecologic cancers owing to both patient and disease-related factors. We evaluated the rate and reasons for hospital readmission within 30 days of ileostomy creation in patients with a gynecologic malignancy.

Methods

We performed a retrospective review of women with gynecologic malignancies who underwent ileostomy creation between 2002 and 2013.

Results

Fifty-three patients were eligible for analysis. The mean age was 63.3 years. Most patients had ovarian cancer (86.5%). Indications for ileostomy included small bowel obstruction (45.3%), as part of primary debulking (18.9%), or treatment of an anastomotic leak (15.1%). The 30-day readmission rate was 34%. Co-morbid diseases such as hypertension (p = 0.008) and chronic kidney disease (p = 0.010) were more common among women who were readmitted. The most common reasons for readmission were dehydration (38.9%) and acute renal failure (33.3%); women readmitted for these conditions had higher average serum creatinine levels at initial postoperative discharge (1.00 mg/dL versus 0.71 mg/dL, p = 0.017) than women who did not require readmission. Readmitted women had a trend toward shorter overall survival (0.41 years versus 1.67 years, p = 0.061).

Conclusions

Readmission rates for gynecologic oncology patients undergoing ileostomy were similar to, but higher than those previously reported in the colorectal literature. In our population, patients with preexisting cardiovascular or renal disease were at the highest risk of readmission and may benefit from preemptive strategies to decrease high ostomy output and dehydration.     

Is venous thromboprophylaxis necessary in patients undergoing minimally invasive surgery for a gynecologic malignancy?

Objectives

Current recommendations for the use of venous thromboprophylaxis in patients undergoing minimally invasive surgery (MIS) for a gynecologic malignancy are derived from patients undergoing open surgery. Our objective was to determine the 30-day prevalence of symptomatic venous thromboembolism (VTE) after laparoscopic gynecologic oncology procedures in patients who received no thromboprophylaxis.

Methods

Between January 2006 and September 2013, women who underwent MIS for endometrial, cervical or ovarian cancer at a single institution were included. Data on patient demographics, diagnosis, comorbidities, perioperative characteristics, use of thromboprophylaxis, and diagnosis of VTE were collected retrospectively.

Results

Of the 419 patients who underwent MIS for a gynecologic cancer, 352 (84%) received no VTE prophylaxis. At least a total laparoscopic hysterectomy (simple or radical) or pelvic lymph node dissection was performed in 95% of these patients. The median length of surgery was 137 min and 95% of patients were discharged home within 1 day of surgery. The rate of VTE in the 352 untreated patients was 0.57% (1 pulmonary embolism and 1 deep vein thrombosis). There were no VTE diagnosed within 30 days of surgery in the 67 patients who received anticoagulant thromboprophylaxis.

Conclusion

The rate of VTE is low in patients undergoing minimally invasive surgery for a gynecologic malignancy despite no VTE prophylaxis. The benefits of routine use of VTE prophylaxis in this population are questionable.     

Diffusion of Enhanced Recovery principles in gynecologic oncology surgery: Is active implementation still necessary?

Objective

Spontaneous diffusion of the evidence-based Enhanced Recovery After Surgery (ERAS) program from an early adopter department (colorectal surgery) to other closely related departments (gynecologic surgery) within the same hospital could be expected. Given this diffusion hypothesis, this quality improvement study examines the value of active implementation of ERAS in addition to spontaneous diffusion.

Methods

A nonrandomized, pre-post intervention study was conducted at a tertiary referral hospital. Prospective data of consecutive patients who underwent abdominal surgery between March, 2010 and March, 2011 for gynecologic malignancies were collected and compared with those of a historical cohort of patients treated before the structured implementation of ERAS by an expert team. Outcomes were length of hospital stay, length of functional recovery, and compliance to protocol care elements.

Results

Seventy-seven patients treated after structured implementation of ERAS were compared with 38 patients included in the historical cohort. Most women had surgery for ovarian or endometrial cancer (48% and 37% respectively). Postoperative care mostly lacked ERAS elements and needed to be actively implemented. With structured implementation, a reduced time to functional recovery (median 3 versus 6 days, p < 0.001) and a shorter length of hospital stay (5 versus 7 days, p < 0.001) were achieved.

Conclusions

After several years of practicing ERAS in colorectal surgery, spontaneous spread of ERAS principles to gynecologic oncology surgery occurred partially. The results of this study underscore the need for a structured and supported pro-active process to implement the ERAS program in a complete and successful way.     

Is bariatric surgery an option for women with gynecologic cancer? Examining weight loss counseling practices and training among gynecologic oncology providers

Objective

The objective of this study was to evaluate gynecologic oncology provider (GOP) practices regarding weight loss (WL) counseling, and to assess their willingness to initiate weight loss interventions, specifically bariatric surgery (WLS).

Methods

Members of the Society of Gynecologic Oncology were invited to complete an online survey of 49 items assessing knowledge, attitudes, and behaviors related to WL counseling.

Results

A total of 454 participants initiated the survey, yielding a response rate of 30%. The majority of respondents (85%) were practicing GOP or fellows. A majority of responders reported that > 50% of their patient population is clinically obese (BMI ≥ 30). Only 10% reported having any formal training in WL counseling, most often in medical school or residency. Providers who feel adequate about WL counseling were more likely to offer multiple WL options to their patients (p < .05). Over 90% of responders believe that WLS is an effective WL option and is more effective than self-directed diet and medical management of obesity. Providers who were more comfortable with WL counseling were significantly more likely to recommend WLS (p < .01). Approximately 75% of respondents expressed interest in clinical trials evaluating WLS in obese cancer survivors.

Conclusions

The present study suggests that GOP appreciate the importance of WL counseling, but often fail to provide it. Our results demonstrate the paucity of formal obesity training in oncology. Providers seem willing to recommend WLS as an option to their patients but also in clinical trials examining gynecologic cancer outcomes in women treated with BS.     

Initial experience of robotic anterior pelvic exenteration at a single institute

Objective

To present the initial experience with robotic anterior pelvic exenteration in patients with advanced pelvic cancer at Galaxy Care Laparoscopy Institute, Pune, India.

Methods

A retrospective chart review of data from 10 patients with advanced cervical carcinoma and bladder involvement or with vault recurrence following hysterectomy who were treated at the study hospital between November 2009 and May 2011. Clinicopathologic data and postoperative data including operative time, blood loss, blood transfusions, hospital stay, lymph node yield, and complications were recorded.

Results

The mean operative time was 180 minutes, the mean blood loss was 110 mL, and the mean duration of hospital stay was 5 days. There were no treatment-related morbidities or mortalities. A mean parametrial clearance of 3 cm with a distal vaginal margin of 3.5 cm was achieved. All patients had tumor-free margins. The mean number of harvested lymph nodes was 24. Six patients had positive lymph nodes on pathologic examination and were treated with chemoradiotherapy. At a median follow-up of 11 months, 8 patients were disease-free.

Conclusion

Robot-assisted anterior pelvic exenteration had favorable operative, pathologic, and short-term clinical outcomes. A large multicenter study is required to confirm the results.     

Deep venous thrombosis in gynecological oncology: Incidence and clinical symptoms study

Objective

Cancer patients have increased risks of leg deep venous thrombosis (DVT). We studied the incidence, risk factors and most predictive symptoms of leg DVT in gynecologic oncology patients.

Study designs

Gynecologic oncology patients with any leg DVT symptoms were recruited and screened using Doppler sonogram. All hospitalized surgery and non-ambulating patients received thigh-high sequential compression devices (SCDs) without heparin as a prophylactic method against thrombosis. Statistical analysis was done using chi-square or Fisher's exact tests.

Results

Out of 1974 patients, 134 complained of lower limb symptoms. Doppler studies found 38 patients with leg DVT. Incidence of leg DVT was 36/853 (4.2%) in patients with cancer and 2/1121 (0.2%) in patients without cancer (odds ratio 2.8 with a diagnosis of cancer). Leg edema, erythema, fever, and warm leg were significant symptoms in diagnosing leg DVT (p < 0.01). The cost of finding a leg DVT was $747.54.

Conclusions

Clinical exam is less accurate than Doppler sonogram in diagnosing leg DVT. The incidence of leg DVT using SCD seems to be comparable with other studies. Finally, the cost of identifying leg DVT seems reasonable.     

Early surgical repair of iatrogenic ureterovaginal fistula secondary to gynecologic surgery

Objective

To describe the early surgical repair of iatrogenic ureterovaginal fistula (UVF) secondary to gynecologic surgery, and evaluate the efficacy and feasibility of early surgical intervention.

Methods

Data were retrospectively reviewed for 52 patients with iatrogenic UVF who underwent early surgical repair between January 1996 and January 2011 at the Sir Run Run Shaw Hospital, Hangzhou, China. Preoperative patient characteristics and postoperative endpoints, including type of index procedure, repair technique, operative time, perioperative complications, and postoperative follow-up data were assessed.

Results

All early surgical repairs were uneventful. The mean time from diagnosis to surgery was 15.7 days (range, 14–21 days). The mean operative time was 73.4 min (range, 51–110 min) for ureteroneocystostomy, and 104 min (range, 91.5–153 min) for Boari flap procedure. The mean estimated blood loss was 57.8 mL (range, 35–80 mL). No major intraoperative complications occurred, although 5 patients had postoperative surgical site infections. Forty-three patients were followed for a mean of 18.4 months (range, 10.5–24.0 months). Ureteral stricture with asymptomatic hydronephrosis occurred in 2 (4.7%) patients. Ipsilateral renal function was preserved in all patients.

Conclusion

Early surgical repair of UVF secondary to gynecologic surgery was safe and effective, and preserved ipsilateral renal function.     

A randomised controlled trial of placental cord drainage to reduce feto-maternal transfusion

Objectives

To determine whether placental drainage via the umbilical cord prior to placental delivery reduces the size of feto-maternal transfusion and thus the chance of rhesus isoimmunisation in rhesus negative women.

Study design

A randomised controlled trial conducted in a tertiary hospital setting in the UK compared 18 rhesus negative women who had placental drainage (10 caesarean section and 8 vaginal deliveries) with 18 rhesus negative women where the cord remained clamped until placental delivery (8 caesarean section and 10 vaginal deliveries). Maternal venous blood samples were taken before delivery and at a mean of 142 min after delivery of the placenta, and analysed using flow cytometry to calculate the size of the feto-maternal transfusion. The statistical analysis was performed using SPSS Version 13 statistical software. The main outcome measure was the quantification of the volume of fetal cells in the maternal circulation before and after delivery.

Results

In the 72 specimens taken, 40 demonstrated measurable amounts of fetal cells in the maternal circulation. In the 18 women who had placental drainage, the mean (SD) size of the feto-maternal transfusion was 0.50 ml (0.79) before and 0.39 ml (0.58) after delivery. In the 18 women who had a clamped cord, the mean (SD) feto-maternal transfusion was 0.46 ml (0.84) before and 0.78 ml (1.1) after delivery. There was no significant difference between the net feto-maternal transfusions in the two groups (Mann–Whitney U 122.5, p 0.19).

Conclusion

Placental drainage does not reduce the amount of feto-maternal transfusion and this method of placental delivery is not recommended to reduce feto-maternal transfusion.     

Efficacy of continuous wound infiltration of local anesthetic for pain relief after gynecologic laparoscopy

Objective

To assess the efficacy of analgesia provided by continuous ropivacaine wound infiltration after gynecologic laparoscopy.

Methods

Sixty patients who underwent gynecologic laparoscopy at Ajou University School of Medicine, Suwon, Republic of Korea, between March and May 2012 were randomized to receive either intravenous fentanyl and ketorolac infusion on demand by patient-controlled analgesia (IV PCA group, n = 31) or continuous wound infiltration of local ropivacaine (CWI group, n = 29). Postoperative pain and postoperative nausea and vomiting (PONV) were assessed via a visual analog scale. The number of patients who requested rescue analgesia was recorded.

Results

There was no significant difference in postoperative pain between the 2 groups, but more patients requested rescue analgesia in the CWI group than in the IV PCA group in 24 hours (18 versus 9 patients, respectively; P = 0.010). The PONV scores at 12 and 24 hours were, respectively, 0.28 and 0.27 in the CWI group, and 0.71 and 0.73 in the IV PCA group (P = 0.004). Nine patients requested cessation of IV PCA because of severe nausea or vomiting.

Conclusion

Continuous ropivacaine wound infiltration was found to be as effective as patient-controlled analgesia for postoperative pain relief after gynecologic laparoscopy. This technique provides good analgesia with less opioid analgesic requirement and few adverse effects.     

Predicción de anemia fetal por isoinmunización tras transfusiones intrauterinas. Revisión de los casos tratados en nuestra unidad

Objetive

Evaluate the intrauterine blood transfusions performed in fetuses with anemia due to red blood cell alloimmunization in our unit and the detection rate of the middle cerebral artery Doppler to predict anemia after the first transfusion.

Material and methods

We performed 53 intrauterine blood transfusions in 15 patients with red blood cell alloimmunization. We analyze the characteristics of the cases and the value of the middle cerebral artery Doppler to predict fetal anemia.

Results

The detection rate of fetal anemia with the peak systolic velocity Doppler in the middle cerebral artery was 85% after the first transfusion and 72% after the second or more. There were no false positive results of the test in our series.

Conclusions

Doppler evaluation of the middle cerebral artery as predictor of fetal anemia has a lower detection rate after consecutive transfusions.     

Prospective Quality of Life Outcomes Following Robotic Surgery in Gynecologic Oncology

Purpose

To characterize the health-related quality of life (HRQL) of patients undergoing robotic surgery for the treatment of gynecologic cancers.

Methods

211 patients completed a quality of life questionnaire before surgery. Postoperative questionnaires, consisting of the same assessment with the addition of postoperative questions, were given at 1 week, 3 weeks, 3, 6, and 12 months after surgery. The Functional Assessment of Cancer Therapy—General (FACT-G) and its subscales were used to evaluate HRQL. Patient-rated body image was evaluated using the Body Image Scale. Statistical significance was measured by the Wilcoxon signed-rank test. Minimally important difference (MID) values were analyzed to evaluate clinical significance.

Results

Overall HRQL and body image decreased at 1 week after surgery and returned to baseline by 3 weeks. Physical and functional well-being decreased at 1 week after surgery and returned to baseline by 3 months after surgery. However, using MID criteria, physical well-being returned to baseline by 3 weeks. Social well-being did not change significantly. Emotional well-being increased immediately by 1 week after surgery.

Conclusion

Patient reported HRQL outcomes following robotic surgery for the treatment of gynecologic cancers suggests a rapid return to pre-surgery values.     

Incidence of port site hernias and/or dehiscence in robotic-assisted procedures in gynecologic oncology patients

Objectives

The incidence of port site hernia and/or dehiscence using bladeless trocars is 0–1.2%. Robotic surgery uses additional port sites and increases manipulation of instruments, raising the concern for more complications. We sought to characterize the incidence of port site complications following robotic surgery when fascia was not routinely closed.

Methods

Robotically-assisted (RA) procedures performed for suspected gynecologic malignancy between 1/2006 and 12/2011 were retrospectively reviewed. Bladeless 12 mm and 8 mm robotic trocars were used. Fascial closure was not routinely performed except after specimen removal through the port site. The decision to close the fascia remained at the discretion of the surgeon.

Results

Data from 842 procedures were included. Mean patient age was 55.6 years. Mean Body Mass Index was 33.6 kg/m². RA-total laparoscopic hysterectomy (TLH) ± unilateral or bilateral salpingo-oophorectomy (BSO) ± lymphadenectomy (LND) accounted for 91.6% of procedures. Final pathology confirmed malignancy in 58.6% of cases, primarily endometrial cancer. In 35 cases, the specimen was removed through the port site; fascia was closed in 54.3% of them and no port site hernias or dehiscences occurred. Only one patient underwent a RA-TLH/BSO/LND for endometrial adenocarcinoma and had a port site dehiscence of the 8 mm trocar site. No port site hernias occurred.

Conclusion

Port site hernias and dehiscences are rare in RA gynecologic oncology procedures. When bladeless dilating trocars are used, routine closure of even up to a 12 mm port site is unnecessary, even in cases requiring removal of the specimen through the trocar sites.     

Aportación del Doppler de la arteria cerebral media y del genotipado RHD fetal en el manejo de la isoinmunización

Objective

To assess the clinical application of non-invasive methods in the management of alloimmunization from 2006 to 2010.

Subjects and methods

Seventy pregnancies with risk of fetal anemia were studied by fetal middle cerebral artery peak systolic velocity (MCA-PSV). The efficacy of MCA-PSV was compared between the first, second and third transfusions. Prenatal testing of fetal RHD blood group using maternal blood was performed in pregnancies followed-up in our center.

Results

Fetal blood sampling was performed in 22 pregnancies; of these, fetal transfusion was carried out in 20. Detection rates and the false-positive rate of MCA-PSV in the prediction of severe or moderate fetal anemia were 89% and 15% in pregnancies with no previous transfusions, 100% and 41% in patients with one previous transfusion, and 40% and 24% when more than one transfusion was performed.

Conclusion

MCA-PSV has high sensitivity when there is one previous fetal transfusion but its specificity is lower.