O33.0 O82
Conditions
Interventions
Group 1: Transperitonael Cesarean Section (TCS)
classical method with opening of the peritoneal cavity
Group 2: Extraperitoneal Cesarean Section (ECS)
New method without opening of the peritoneal cavity
Sponsors
Univ. Frauenklinik Med.Universität Graz
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients will be invited to participate if they are 18 years or older and present with an indication for an elective caesarean section (primary or first repeat caesarean section) at 37 weeks of gestation or more.
Exclusion criteria
Exclusion criteria: Patients suspected of abnormal placentation (Placenta accreta, increta, percreta), with placenta previa, with a history of more than one caesarean section or with a history of major abdominal surgeries will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is maximum abdominal pain (peak pain) on post operative day 1 measured by NRS scale ranging from 0-10. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be intraoperative nausea and vomiting, postoperative thoracic and shoulder pain, bowel dysfunction and urogenital dysfunction, respectively. Staff physicians will evaluat the severity of symptoms on the day of discharge by means of a questionnaire with numeric rating scales corresponding to the 0-10 pain scale. A rating of “0” corresponded to the best result whereas a rating of “10” corresponded to the worst result of any particular question. Urogenital distress will be determined using a Urogenital Distress Inventory (UDI). The UDI reflects three aspects of urogenital dysfunction: irritative symptoms (UDI-I), obstructive discomfort (UDI-O) and stress symptoms (UDI-S). The originally ranging three subscales from 0 to 100 will be adapted for consistency to the 0-10 NRS-scale. Other secondary outcomes are as follows. All surgical complications will be recorded and blood loss will be estimated by the difference in hemoglobin on the day of surgery and postoperative day 1 (POD1). Neonatal outcome will be defined by Apgar scores, umbilical pH-values and neonatal weight. Delivery time, operative time, need for analgesics, white blood count (WBC) on POD1 and length of postoperative hospital stay will be recorded for each patient. Six weeks after surgery patients will be contacted by a telephone survey based on the 0-10 NRS- scale questionnaire re-evaluating urogenital distress, urinary tract infection, bowel dysfunction, need for analgesics and asking for overall satisfaction with the procedure. | — |
Countries
Austria
Contacts
Public ContactWolfgang Schöll
Univ. Frauenklinik Graz
Outcome results
None listed