Type IIIb Jejunal Atresia. Congenital absence, atresia and stenosis of jejunum
Conditions
Interventions
Intervention 1: Intervention group: Surgery using innovative Seromuscular Mesoplasty technique (creation of seromuscular flap at intestinal anastomosis site) under standard neonatal anesthesia
Neonates undergo standard primary end-to-end jejunal anastomosis for Type IIIb atresia. After laparotomy, the proximal and distal ends are directly anastomosed without any seromuscular flap or reinfor
Sponsors
Vice-Chancellery for Research, Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Days to 28 Days
Inclusion criteria
Inclusion criteria: Neonates diagnosed with jejunal or jejunoileal atresia type IIIa or IIIb confirmed intraoperatively or by imaging. Age at enrollment within neonatal period (birth to 28 days). Hemodynamically stable status prior to surgical intervention. Absence of severe congenital anomalies in other organ systems. Candidates eligible for primary surgical repair of jejunal atresia. No previous abdominal surgery involving the small intestine. Written informed consent obtained from parents for participation and postoperative follow-up. Admission in Mashhad University-affiliated pediatric hospitals (Akbar or Sheikh Children’s Hospital). Completion of baseline assessment including gestational age, birth weight, and preoperative nutritional status. Family able and willing to respond to follow-up contacts and visits.
Exclusion criteria
Exclusion criteria: Neonates with severe congenital anomalies in other organ systems (e.g., cardiac, renal, or neurologic defects). Presence of severe underlying medical conditions affecting surgical outcome or recovery (e.g., sepsis, multi-organ failure). Requirement for simultaneous surgical intervention for additional anomalies besides jejunal atresia. Hemodynamic instability at the time of surgical decision-making. Known chromosomal or genetic syndromes. Birth weight < 1500 g (very-low-birth-weight preterm neonates). Gestational age < 32 weeks. Clinical evidence of active sepsis prior to surgery. History of previous abdominal surgery causing adhesions or altered intestinal anatomy. Absence of written informed consent from parents. Parents unable or unwilling to participate in postoperative follow-up or telephone contact. Neonates admitted outside Mashhad Children’s Hospitals (Akbar or Sheikh) without standardized surgical protocols. Prior exposure to any experimental intestinal surgical technique before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Leak of Anastomosis: Detection of intestinal content leakage from anastomotic site within 30 days post-surgery, confirmed clinically or radiologically. Timepoint: Assessed daily until discharge and on postoperative day 30. Method of measurement: Detection of intestinal content leakage from anastomotic site through clinical observation (drain output, tenderness, fever) and confirmation via water-soluble contrast radiography.;Wound Infection: Occurrence of surgical-site infection graded by Clavien–Dindo within 30 days post-operation. Timepoint: Evaluated on days 7, 14, and 30 post-operation. Method of measurement: Surgical-site infection assessed by inspection of wound appearance, discharge, redness and swelling by surgical evaluator classified according to Clavien–Dindo criteria.;30-day Mortality: All-cause mortality within 30 days after neonatal intestinal surgery. Timepoint: Continuous monitoring until postoperative day 30. Method of measurement: Survival status recorded up to 30 days after surgery based on hospital records and follow-up telephone contact with parents.;Time to Full Enteral Feeding (TFFE): Number of days from surgery to achievement of full oral enteral feeding without parenteral support. Timepoint: Recorded daily from initiation of oral feeding until full enteral tolerance. Method of measurement: Recorded daily from initiation of oral feeding until full enteral tolerance.;?Short Bowel Syndrome: Clinical existence of short-bowel syndrome defined by dependence on parenteral nutrition > 6 weeks after surgery. Timepoint: Assessed at weeks 4 and 8 post-surgery and at end of follow-up (12 months). Method of measurement: Clinical monitoring plus recorded residual bowel length in operative note and dependence on parenteral nutrition for more than six weeks after surgery.;Length of Hospital Stay (LOS): Number of days from admission to discharge recorded in patient file. Timepoint: From surgery day until hospital discharge. Method of measur | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgery Duration: Time interval from the first skin incision to the final skin suture, in minutes. Timepoint: During surgery. Method of measurement: Measured using the digital operating room clock; recorded by the scrub nurse in the operative report.;Intraoperative Blood Loss: Total blood loss during the surgical procedure, measured in milliliters. Timepoint: During surgery. Method of measurement: Calculated from the difference between aspirated fluid and irrigation volumes plus change in sterile gauze weight before and after surgery; documented in operative note.;Long-term Growth Outcomes: Physical growth indicators including weight, height, and head circumference at 3-, 6-, and 12-month follow-up visits. Timepoint: At 3, 6, and 12 months post-surgery. Method of measurement: Weight measured with calibrated digital scale, height with standard stadiometer, and head circumference with non-stretchable measuring tape; compared with WHO growth charts.;Need for Re-operation: Any repeat surgical procedure related to the anastomosis or primary operative site within 30 days of initial surgery. Timepoint: From day of surgery to day 30 post-operation. Method of measurement: Documented in the patient’s medical record based on surgical reports and hospital readmission data.;Onset of Bowel Movements: Time to first passage of flatus or stool after surgery. Timepoint: From day of surgery until first occurrence. Method of measurement: Recorded in nursing chart based on patient report or direct observation by ward nurse.;Initial Oral Feeding Tolerance: Patient’s ability to tolerate the first oral feeding without signs of intolerance (vomiting, abdominal distension, diarrhea) after surgery. Timepoint: From initiation of oral feeding until 24 hours thereafter. Method of measurement: Daily clinical assessment and documentation of feeding tolerance in nursing sheets.;Non-infectious Minor Complications: Occurrence of any non-infectious complication such as minor hematoma, limited necrosis | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKhashayar Atqiaee
Mashhad University of Medical Sciences
Outcome results
None listed