A novel route for tubal surgery: Transvaginal natural orifice transluminal endoscopic surgery

Natural orifice transluminal endoscopic surgery (NOTES) is a challenging minimally invasive procedure where ‘scarless’ abdominal surgeries are performed through an endoscope inserted through a natural orifice (mouth, anus, vagina, and urethra) and is considered as a less invasive approach to laparoscopic surgeries.

NOTES is considered a logical next step in the evolution of minimal invasive surgery, and the first NOTES procedure in humans is often considered to be a transgastric appendectomy performed in India in 2006 which was presented but not reported in manuscript form.

vNOTES is a natural orifice surgery performed through the vaginal route. A look into history reveals that gynecologists have been performing colpotomies for years, adding their valuable experience towards NOTES surgeries and subsequent closure.

A recently published paper in July issue of Fertility and Sterility have demonstrated a new technique of performing tubal reanastomosis via the vaginal route. The step-by-step procedure is explained in the accompanying video, using the surgical case of a 42-year-old female G2P2 with a history of tubal ligation 11 years before, who requested a tubal reanastomosis.   

A three-dimensional sonohystogram at 8 weeks postop showed bilateral patency of both the fallopian tubes.

The current method of performing tubal reanastomosis involves a minimal invasive surgery with end-to-end anastomosis with a 60% to 90% success rate of post-operative intrauterine pregnancy.

A recent systematic review comparing laparotomy vs laparoscopy vs robotic mode of surgery showed that laparotomy had the worst outlook.

NOTES have the advantage of a fast recovery, no abdominal incision, and an extremely cosmetic outcome. With prophylactic antibiotic, the current rate of pelvic infection with NOTES is a 0%–3.1%.

In the hands of a skilled minimally invasive surgeon, vNOTES offers an alternate route for tubal surgery.

Here is a video showing the stepwise surgical procedure 

Abstract

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New approach to ovarian cystectomy: Transvaginal natural orifice transluminal endoscopic surgery

New approach to myomectomy: Transvaginal natural orifice transluminal endoscopic surgery

FDA clears the first smartphone camera-based clinical grade at-home urine test

An Israel-based Healthy.io has received FDA 510(k) clearance for Dip.io, a home-based urinalysis kit that transforms the smartphone into a clinical-grade urine diagnostic device. It is the first smartphone-based urine test to secure clearance as a Class 2 device.

Millions of people around the globe such as pregnant women, those suffering from kidney disease, diabetes, high blood pressure and others are required to get their urine tested very frequently- but going to the lab every day is very cumbersome and time-consuming. Dip.io let patient perform urine test in the privacy of their home with results that are equivalent to a hospital-based lab urine test.

The Dip.io kit comes with a cup, dipsticks and patented colorboard. The user simply opens the smartphone apps and is guided step-by-step through the kit by the chatbot nurse named Emily. After peeing in the cup, the user dips the stick and places it on the colorboard. After a lapse of 60 seconds the dipstick and the board are scanned, the image normalized, and data points are sent to the cloud platform to be analyzed and turned into clinical results.

The results are conveyed to the health care provider or directly stored as a part of the patient’s medical record.

The app is straightforward to use as apparent from the tagline “If you can text, you can test,” and has achieved more than 99 percent usability across age groups ranging from 18-80 because of rapid prototyping and repeated user testing. 

The dipstick measures 10 parameters including blood, protein, and glucose in urine and is enormously useful for patients with chronic kidney disease, diabetes, and high-risk pregnancies.

The FDA approval is based on the demonstration of the significant rise in the use of the Dip.io platform by patients of chronic kidney disease as reported by the results of a study initiated by the National Kidney Foundation (NKF) and Geisinger Health.

The Dip.io technology has already been approved by the National Health Trust of UK and is nationally available through the G-Cloud procurement framework. It is also a part of NHS first 'virtual renal clinic' to improve patient convenience and improve cost.

Already commercialized in Europe and Israel since 2016, it is estimated that it will be utilized by 100,000 users by the end of 2018 through different patient pathways, shifting more and more urine testing from labs to homes.

Healthy.io is currently working on expanding the technology for at home assessment of chronic wound through ‘medical-selfies.’

Arming patients with the capability to conduct the critical tests at home with the same accuracy as the lab will curb the tide of many chronic diseases, simplify their daily routine and bring down the healthcare cost significantly.

Press Release

Healthy.io homepage

National Kidney Foundation study

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Here is a short video about how the product works

Here is an animation describing the company’s intention behind developing the product

Healthy IO (Full Version) from Peepshow on Vimeo.

Room air is as good as oxygen for fetal resuscitation during labor

In an intention to treat analyses, as compared to room air use of oxygen for intrauterine resuscitation of patients with category II fetal heart tracings does not result in a better fetal outcome or improve fetal metabolic status. The findings were published online July 23, 2018, in JAMA Pediatrics.

Two-thirds of women in labor are given oxygen in an attempt to reverse perceived fetal hypoxemia and prevent acidemia. It is also routinely administered to all laboring mother with intermediate risk for acidemia as evident by the category II fetal heart tracings.

American Academy of Pediatrics recommends against initial neonatal resuscitation with oxygen, as hyperoxygenation results in significant morbidity.

A 2012 review also states, “There is not enough evidence to support the use of prophylactic oxygen therapy for women in labor, nor to evaluate its effectiveness for fetal distress.”

Dr. Raghuraman from the Department of Obstetrics and Gynecology, Washington University School of Medicine in St Louis, St Louis, Missouri designed this randomized, noninferiority trial to test the hypothesis that room air is as good as oxygen in improving fetal metabolic status as represented by umbilical artery lactate. (ClinicalTrials.gov Identifier: NCT02741284)

Umbilical artery lactate is a marker of metabolic acidosis and neonatal morbidity.

Women in labor with singleton pregnancies at 37 weeks’ gestational age, admitted to a single tertiary center were eligible to be included in the study (705). Of these, 114 patients developed a category II tracing and were randomized to receive either room air without a face mask or 10 L of oxygen per minute by nonrebreather facemask until delivery.

There was no significant difference in the levels of umbilical artery lactate between the oxygen group (30.6 mg/dL) and the room air group (31.5 mg/dL). The two groups were also similar regarding pH, base deficit, the partial pressure of oxygen, and partial pressure of carbon dioxide.

The rates of operative vaginal delivery or cesarean section for non-reassuring fetal heart rate were also similar in both the groups.

Three other previous studies have also shown similar results, prompting Dr. Christopher P. Bonafide from Children's Hospital of Philadelphia and the University of Pennsylvania Perelman School of Medicine, who co-authored an editorial related to this report to urge the medical societies responsible for issuing evidence-based guidelines for obstetrics such as the American College of Obstetricians and Gynecologists to re-examine the most current research and consider issuing new recommendations against maternal supplemental oxygen administration when fetal tracings are intermediate risk.

Dr. Nandini Raghuraman quotes to Reuters Health by email, "I found it very interesting that substituting room air for oxygen did not impact umbilical cord gases, we typically administer maternal oxygen supplementation in hopes of improving fetal status as interpreted by electronic fetal monitoring. Our results suggest that this may not be the case."

She further added, "Another important point this study raises is that we lack high-quality data for many of our commonly used intrauterine resuscitation techniques. The results call for a closer look and thorough understanding of how these techniques affect fetal and maternal physiology."

Three other previous studies have also shown similar results, prompting Dr. Christopher P. Bonafide from Children's Hospital of Philadelphia and the University of Pennsylvania Perelman School of Medicine, who co-authored an editorial related to this report to urge the medical societies responsible for issuing evidence-based guidelines for obstetrics such as the American College of Obstetricians and Gynecologists to re-examine the most current research and consider issuing new recommendations against maternal supplemental oxygen administration when fetal tracings are intermediate risk.

Abstract

Editorial

ACOG: Management of intrapartum fetal heart rate tracings. ACOG practice bulletin no. 116

Cochrane review: Maternal oxygen administration for fetal distress

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