Endometriosis fertility index can accurately predict a women’s chances of conception after laparoscopy

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The Endometriosis fertility index can accurately predict the possibility of non-ART conception or the need of ART for achieving pregnancy after surgical resection of moderate-severe (Stage III–IV) endometriosis reports the results of study published in Human Reproduction. The study confirmed that adnexal function is deciding factor in evaluation of fertility prognosis after the surgery.

There is no evidence based guidelines about post-surgery fertility management of women who have undergone surgery for severe endometriosis. Physicians differ in their approach about the length of conservative treatment and that sometimes add years and causes unnecessary delays.

The researchers in this study from Australia, led by Dr. Sarah Maheux-Lacroix of the Royal Hospital for Women in Randwick, looked into data of 279 women who had undergone laparoscopic surgery for stage III-IV and were trying to become pregnant.

Endometriosis fertility index was first published in 2010 and is a robust tool to predict fertility after surgical staging of endometriosis.

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The EFI is combines obstetrical and surgical factors to predict a woman’s chance of becoming pregnant. In addition to all the components of the revised-American Society of Reproductive Medicine score, it also includes a detailed evaluation of the fallopian tubes, fimbriae, and ovaries, and accounts for any adnexal dysfunction after surgery.

The researchers calculated EFI for all these women based on detailed operative reports and surgical images plus the obstetric history of women.

The average follow-up was 4 years during which 147 women (63%) gave birth, of which 94 conceived naturally without ART.

None of the women with EFI 0-2 conceived, while 91% women with EFI 9-10 had live births in 5 years period after surgery.

Similarly, women with EFI 0-2 had a success rate of 38% with ART, while those with EFI 9-10 had a success rate of 71%.

So, low EFI was significant in predicting failure to conceive (P = 0.003) in addition to other factors which adversely affected the pregnancy rates like being older than 40 years (P = 0.027), having uterine fibroids (P = 0.037) and history of previous resection (P = 0.019) or incomplete resection (P = 0.028).

The only drawback of the study was its retrospective nature.

The researchers concluded that the tool can be used to predict the fertility prognosis in women after surgery for endometriosis. Depending on the EFI score, the obstetrician can advise patients about timed intercourse or refer the patients  for ART, without wasting precious years.

Abstract

FDA approves Senhance Surgical Robotic System to facilitate minimally invasive surgery

FDA today approved Senhance Systems, by TransEnterix, Inc., a medical device company that is pioneering the use of robotics to improve minimally invasive surgery.

Robotically-assisted surgical device (RASD) is a type of computer assisted surgical system, which helps surgeon to control, view and move the surgical devices through small ports of minimal invasive surgery in a variety of surgical procedures. It specifically has gynecological and colorectal applications.

The system enables the surgeon to sit in a console or a cockpit of some sort, which provides him or her with a 3D, high-definition view of the surgical field and allows for the control of the system’s 3 robotic arms. At the end of each of the 3 arms are mounted surgical instruments that are based on traditional laparoscopic instrument designs. This increases the surgeon’s comfort and reduces strain.

The system allows the surgeon to “feel” the stiffness of tissue during operation with its force feedback technology. It also features eye-tracking to allow for comparative movement of instruments to standard operations. It facilitates highly efficient operations with minimal additional docking time or change to technique.

 It allows for the visualization and endoscopic manipulation of human tissue, such as grasping, cutting, blunt and sharp dissections, approximation, ligation, electrocautery, suturing, mobilization and retraction in laparoscopic colorectal surgery and laparoscopic gynecological surgery," according to the FDA. 

“Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery,” said Binita Ashar, M.D., director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health. “RASD technology is a specialized innovation in minimally invasive surgery designed to enhance the surgeon’s access and visualization within confined operative sites.” 

The clearance was based on results of a pilot study in which 150 patients underwent various gynecological operations with the Senhance System. The clinical outcomes were compared with outcomes of nearly 8000 surgeries in real world settings using another RASD.

In addition to gynecological surgeries, 45 colorectal sureries were also performed by Senhance system and compared to outcomes of other real-world surgeries.

Based on the study results, real world evidence and simulations, the FDA concluded that the  Senhance System is substantially equivalent to the da Vinci Si IS3000 device for gynecological and colorectal procedures.

Here is a  video of Senhance Surgical Systems. 


Senhance Surgical Robotic System - Functional Overview from TransEnterix, Inc on Vimeo.

ACOG updates guidance on postpartum hemorrhage- calls for standard, coordinated, protocol based intervention

The American College of Obstetricians and Gynecologists (ACOG) recently released expanded guidelines for management of postpartum hemorrhage (PPH)—the leading cause of maternal mortality worldwide.

PPH is defined as total blood loss of 1000 ml or more along with signs or symptoms of hypovolemia within 24 hours after the labor, but can occur up to 12 weeks postpartum. Although Maternal Mortality Rates(MMR) have decreased worldwide in last 4 decades, it still accounts for 10% of all pregnancy related mortality.

Incidence varies, but 1-5% is reasonable estimate, with uterine atony accounting for 70-80% of cases PPH.

This practice bulletin discusses the risk factors along with evaluation, prevention, and management of maternal hemorrhage.

It also calls upon all obstetricians and other obstetric care providers to formulate standard protocols for recognizing, evaluating and management of maternal hemorrhage by multidisciplinary approach and implement it in every center.

Multidisciplinary teams, including physicians, nurses and midwives, should be trained to implement key elements in four categories, including readiness to respond; recognition and prevention measures; multidisciplinary response; and data reporting and systematic learning, including drills like simulation-based training.

ACOG also has partnered with multiple organization to implement the care bundle suggested by  Alliance for Innovation on Maternal Health (AIM), which many states have are already adapted.

It also lays emphasis on identifying the patients at risk of developing PPH, prenatally, during admission and during labor. It includes patients with vaginal lacerations, retained placenta, abnormally adherent placenta with previous cesarean section. All Ob-gyn should be aware of high risk of PPH in placenta previa with previous uterine scar.

Uterotonic agents should be the first line of treatment in case of atonic PPH, choice of a specific agent is at the discretion of the provider as none is identified as superior over other. Active management of third stage of labor should be implemented.

All hospitals, especially those in rural areas should be able to escalate the efforts quickly, and have a specific plan to go to next level of treatment or quickly refer patient to a specialty hospital.

Tranexamic acid can be given when primary line of therapy fails, it is especially found effective if given within 3 hours of birth.

Surgical approach includes Intrauterine balloon tamponade, but less invasive methods should always be used first. 

All hospitals should have functioning massive transfusion protocols and ‘hemorrhage carts’, with all the necessary medication in place.

The Practice Bulletin #183, "Postpartum Hemorrhage" is published in October issue of Obstetrics and Gynecology.

ACOG press release

Patient Safety Bundles on obstetric hemorrhage.