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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00004364 |
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Date of registration:
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06/09/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Extraperitoneal versus transperitoneal cesarean section: a prospective randomized comparison of surgical morbidity
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Scientific title:
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Extraperitoneal versus transperitoneal cesarean section: a prospective randomized comparison of surgical morbidity |
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Date of first enrolment:
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05/10/2011 |
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Target sample size:
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54 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00004364 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Austria
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Contacts
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Name:
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Wolfgang
Schöll |
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Address:
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Auenbruggerplatz 2
A-8036
Graz
Austria |
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Telephone:
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+43 316 385 80094 |
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Email:
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wolfgang.schoell@medunigraz.at |
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Affiliation:
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Univ. Frauenklinik bzw.
Ethikkommission Med.Universität Graz |
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Name:
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Wolfgang
Schöll |
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Address:
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Auenbruggerplatz 14
8036
Graz
Austria |
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Telephone:
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+43 316 385 80094 |
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Email:
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wolfgang.schoell@medunigraz.at |
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Affiliation:
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Univ. Frauenklinik Graz |
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Key inclusion & exclusion criteria
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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: 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.
Age minimum:
18 Years
Age maximum:
None
Gender:
Female
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Health Condition(s) or Problem(s) studied
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O33.0
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O33.0
O82
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Maternal care for disproportion due to deformity of maternal pelvic bones
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Single delivery by caesarean section
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Intervention(s)
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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
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Universitätsfrauenklinik und Medizinische Universität Graz
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Ethics review
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Status: Approved
Approval date: 27/09/2011
Contact:
ethikkommission@medunigraz.at
Ethikkommission der Medizinischen Universität Graz
(+43)316-38513928
ethikkommission@medunigraz.at
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