Fetoscopic Repair for Gastroschisis
Palo Alto (17 mi)Overseen bySundeep Keswani, MD
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Baylor College of Medicine
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This trial aims to test a new surgery for unborn babies with severe bowel issues where their intestines are outside their belly. The surgery is done through a small opening in the mother's womb using a camera and tiny tools. This method hopes to reduce complications after birth compared to traditional treatments.
Is the treatment 'Fetal Repair of Complex Gastroschisis' promising?Yes, the treatment 'Fetal Repair of Complex Gastroschisis' is promising because it aims to fix the problem before birth, potentially reducing damage to the baby's intestines and improving health outcomes. Advances in prenatal diagnosis and fetoscopic surgery make this approach more feasible and could lead to better results compared to traditional methods.135910
What safety data exists for fetoscopic repair of gastroschisis?The safety data for fetoscopic repair of gastroschisis is still emerging. The procedure is considered under the criteria for fetal surgery by the International Fetal Medicine and Surgery Society (IFMSS), which includes established natural history, accurate prenatal diagnosis, and absence of fully effective perinatal treatment. While there is experimental evidence for fetoscopic repair and maternal and fetal safety in expert fetal centers, comprehensive clinical safety data is still needed. The procedure is being reconsidered due to advances in prenatal diagnosis and fetoscopic surgery, but further research is required to establish its safety and efficacy.24789
What data supports the idea that Fetoscopic Repair for Gastroschisis is an effective treatment?The available research shows that Fetoscopic Repair for Gastroschisis could be a promising treatment for complex cases of this condition. Complex gastroschisis, which involves more severe complications, often requires multiple surgeries after birth and has higher risks. The research suggests that performing surgery before birth might reduce or prevent damage to the bowel and other complications. Although other methods like amnioinfusion have been tested, they haven't shown proven benefits. Advances in prenatal diagnosis and fetoscopic surgery are making this approach more viable, potentially improving outcomes for babies with complex gastroschisis.14679
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, if you are sensitive to certain antibiotics like Gentamycin, Cefoxitin, Lincomycin, Polymyxin B, and Vancomycin, you may not be eligible due to the use of AlloDerm™ in the trial.
Eligibility Criteria
This trial is for pregnant women over 18 with a single pregnancy between 20-25 weeks, where the fetus has gastroschisis. Candidates must have normal genetic tests and no significant unrelated anomalies or maternal health issues that could complicate surgery.Treatment Details
The study is testing the safety and feasibility of repairing complex gastroschisis in unborn babies using fetoscopy—a surgical procedure performed on the fetus. The aim is to see if this can reduce death and complications after birth.
1Treatment groups
Experimental Treatment
Group I: fetoscopic surgical repairExperimental Treatment1 Intervention
Single arm study. All patients will receive the fetoscopic repair.
Fetal Repair of Complex Gastroschisis is already approved in United States for the following indications:
🇺🇸 Approved in United States as Fetal Repair of Complex Gastroschisis for:
- Complex Gastroschisis
Find a clinic near you
Research locations nearbySelect from list below to view details:
Texas Children's HospitalHouston, TX
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
References
Influence of amnioinfusion in a model of in utero created gastroschisis in the pregnant ewe. [2017]Recent studies on the management of human fetal gastroschisis have produced two major findings: (1) there is an inflammatory response in the amniotic fluid of these fetuses, and (2) amniotic fluid exchange designed to disrupt the inflammatory loop seems to have a favorable impact on the immediate and late outcome of these early operated neonates. To test this hypothesis, we used serial amniotic fluid exchanges in a model of gastroschisis developed in the ewe.
Prenatal management of gastroschisis: the place of the amnioexchange procedure. [2019]Gastroschisis is a malformation of the anterior abdominal wall that consists of a right paraumbilical defect with bowel loops bathed in the amniotic fluid. The survival rate is now greater than 90% and the prognosis relies mainly on morbidity attributable to bowel dysfunction. Recent research has examined gastrointestinal waste present in amniotic fluid that induces bowel toxicity and an inflammatory process. The amnioexchange procedure (changing the amniotic fluid regularly) involves a new therapeutic approach: reducing bowel injuries in the fetuses. This article shows that there is an inflammatory reaction in human gastroschisis and in the authors' model, and that the clinical and biological data plead for the practice of amnioexchange in human beings. A randomized, controlled study is now needed.
Fetoscopic management of gastroschisis in a lamb model. [2021]Gastroschisis is a malformation consisting of an abdominal wall defect with eviscerated bowel. Its standard treatment is postnatal repositioning or temporary prosthetic bag placement. The aim of our study is to evaluate the feasibility of its fetoscopic management in a lamb model.
Complex gastroschisis is a different entity to simple gastroschisis affecting morbidity and mortality-a systematic review and meta-analysis. [2018]Comparison of the outcome of newborns with simple (sGS) and complex gastroschisis (cGS: gastroschisis with atresia, necrosis, perforation or volvulus).
Contemporary trends in the use of primary repair for gastroschisis in surgical infants. [2018]Gastroschisis is a newborn anomaly requiring emergent surgical intervention. We review our experience with gastroschisis to examine trends in contemporary surgical management.
[Gastroschisis: Prenatal ultrasonography and obstetrical criteria for predicting neonatal outcome]. [2017]Prenatal diagnosis of complex laparoschisis is difficult and yet it is associated with a significantly increased morbidity and mortality. The aim of the study was to define ultrasonographic factor and obstetrical criteria to predicting adverse neonatal outcome.
Surgical strategies in complex gastroschisis. [2018]Currently, the most important determinant of gastroschisis outcomes in high resource settings is whether the condition is associated with intestinal complications, such as atresia, necrosis, perforation, or volvulus. This form of the anomaly, known as complex gastroschisis, accounts for most of the mortality and a disproportionate burden of the morbidity from gastroschisis. There is some disagreement about what constitutes complex gastroschisis, and little consensus on the type and timing of surgical interventions. This article establishes a clear definition of complex gastroschisis. Surgical approaches to treatment of the diverse presentations of complex gastroschisis will be described and the timing of such interventions will be discussed. Contemporary outcomes of complex gastroschisis will be reviewed. Finally, a non-congenital intestinal complications that may arise in gastroschisis patients will be discussed.
A randomised controlled trial of amnioexchange for fetal gastroschisis. [2022]Morbidity in fetuses affected by gastroschisis is mainly the result of bowel ischaemic and inflammatory processes. Experimental studies on animal models show that clearing amniotic fluid from the digestive secretions by amnioexchange procedures reduces the inflammatory process. We evaluated the benefit of the amnioexchange procedure for fetal gastroschisis in humans.
Complex gastroschisis: a new indication for fetal surgery? [2021]Gastroschisis (GS) is a congenital abdominal wall defect, in which the bowel eviscerates from the abdominal cavity. It is a non-lethal isolated anomaly and its pathogenesis is hypothesized to occur as a result of two hits: primary rupture of the 'physiological' umbilical hernia (congenital anomaly) followed by progressive damage of the eviscerated bowel (secondary injury). The second hit is thought to be caused by a combination of mesenteric ischemia from constriction in the abdominal wall defect and prolonged amniotic fluid exposure with resultant inflammatory damage, which eventually leads to bowel dysfunction and complications. GS can be classified as either simple or complex, with the latter being complicated by a combination of intestinal atresia, stenosis, perforation, volvulus and/or necrosis. Complex GS requires multiple neonatal surgeries and is associated with significantly greater postnatal morbidity and mortality than is simple GS. The intrauterine reduction of the eviscerated bowel before irreversible damage occurs and subsequent defect closure may diminish or potentially prevent the bowel damage and other fetal and neonatal complications associated with this condition. Serial prenatal amnioexchange has been studied in cases with GS as a potential intervention but never adopted because of its unproven benefit in terms of survival and bowel and lung function. We believe that recent advances in prenatal diagnosis and fetoscopic surgery justify reconsideration of the antenatal management of complex GS under the rubric of the criteria for fetal surgery established by the International Fetal Medicine and Surgery Society (IFMSS). Herein, we discuss how conditions for fetoscopic repair of complex GS might be favorable according to the IFMSS criteria, including an established natural history, an accurate prenatal diagnosis, absence of fully effective perinatal treatment due to prolonged need for neonatal intensive care, experimental evidence for fetoscopic repair and maternal and fetal safety of fetoscopy in expert fetal centers. Finally, we propose a research agenda that will help overcome barriers to progress and provide a pathway toward clinical implementation. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.
Fetal Surgery for Gastroschisis-A Review with Emphasis on Minimally Invasive Procedures. [2022](1) Background: The morbidity of gastroschisis is defined by exposure of unprotected intestines to the amniotic fluid leading to inflammatory damage and consecutive intestinal dysmotility, the viscero-abdominal disproportion which results in an abdomen too small to incorporate the herniated and often swollen intestine, and by associated pathologies, such as in complex gastroschisis. To prevent intestinal damage and to provide for growth of the abdominal cavity, fetal interventions such as amnio exchange, gastroschisis repair or covering have been evaluated in several animal models and human trials. This review aims to evaluate the reported techniques for the fetal treatment of gastroschisis by focusing on minimally invasive procedures. (2) Methods: We conducted a systematic database search, quality assessment and analyzed relevant articles which evaluate or describe surgical techniques for the prenatal surgical management of gastroschisis in animal models or human application. (3) Results: Of 96 identified reports, 42 eligible studies were included. Fetal interventions for gastroschisis in humans are only reported for EXIT procedures and amnio exchange. In animal models, particularly in the fetal sheep model, several techniques of open or minimally invasive repair of gastroschisis or covering the intestine have been described, with fetoscopic covering being the most encouraging. (4) Discussion: Although some promising minimally invasive techniques have been demonstrated in human application and animal models, most of them are still associated with relevant fetal morbidity and mortality and barely appear to be currently applicable in humans. Further research on specific procedures, instruments and materials is needed before any human application.