Actively Recruiting
Preventing Gastrointestinal Disturbance in Patients After Longitudinal Laparotomy.
Led by Orexa BV · Updated on 2024-10-03
126
Participants Needed
3
Research Sites
102 weeks
Total Duration
On this page
Sponsors
O
Orexa BV
Lead Sponsor
Q
QPS Holdings LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-center, randomized, double blind, placebo-controlled, phase 2 pilot efficacy study.
CONDITIONS
Official Title
Preventing Gastrointestinal Disturbance in Patients After Longitudinal Laparotomy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand study requirements and provide written informed consent
- Female patients aged 18 to 75 years
- Undergoing gynecologic surgery completely by longitudinal laparotomy
- ECOG Performance status up to 1
- Likely to comply with the study protocol and complete the study
- Agree to have a peridural catheter (PDC) placed
You will not qualify if you...
- History of gastrectomy, total colectomy, stoma creation, or short bowel syndrome
- Presence of pre-operative ileus
- Use of opioid analgesics exceeding 35 mg morphine equivalent per day for more than two post-operative days
- Chemotherapy treatment within 10 days after longitudinal surgery
- Smoking during hospital stay
- Contraindications to local anesthetics for PDC
- History of uncontrolled cardiovascular, renal, or hepatic failure
- History of severe allergic or anaphylactic reactions to local anesthetics
- Clinically significant abnormal laboratory values or ECG
- Use of class 1B antiarrhythmic drugs for antiarrhythmic purposes or class 3 potassium channel blockers
- Recent significant symptomatic infections requiring antibiotics within past 2 weeks
- Use of experimental agents within 30 days or ten half-lives prior to study medication
- Pregnancy or planning pregnancy during the study
- Any other condition that precludes participation as judged by the Investigator
- Close affiliation with Investigator, study site personnel, or Sponsor employees
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Universitätsklinikum Bonn (UKB).
Bonn, Germany
Actively Recruiting
2
Kaiserswerther Diakonie Florence-Nightingale- Krankenhaus
Düsseldorf, Germany, 40489
Actively Recruiting
3
Klinikum Wolfsburg
Wolfsburg, Germany, 38440
Actively Recruiting
Research Team
A
Ard Peeters, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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