Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
61 participants
INTERVENTIONAL
2012-05-31
2013-01-31
Brief Summary
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SUTURE-CLOSURE OMENTOPEXY VERSUS OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER
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Detailed Description
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The patients will be randomized according to their protocol number given automatically by the registration system of the hospital during admission. The patients who have an odd protocol number will have conventional surgical protocol, and those who have an even protocol number will have fast-track surgery protocol.
The conventional surgical protocol for perforated peptic ulcers is composed of regular general anesthesia, postoperative pain control by intravenous analgesics, removal of nasogastric tube by the end of 48th postoperative hour, initiation of oral intake after clinical signs of active bowel movement is observed. Fast-track surgery protocol, however, is composed of general anesthesia with short-acting agents and the use of regional anesthesia if possible, removal of nasogastric tube during recovery from anesthesia, aggressive pain control, initiation of oral intake by the end of 48th postoperative hour.
All of the patients will be scheduled for control gastroscopy in the end of six weeks after surgery.
Primary end-point is the morbidity and mortality rate. Secondary end-points are length of hospital stay, readmission rate, endoscopic findings in control gastroscopy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional surgery
The patients who will have a conventional surgical treatment will be included.
Surgical repair of perforated peptic ulcer
Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty.
Fast-track surgery
The patients who will have fast-track surgery will be included.
Surgical repair of perforated peptic ulcer
Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty.
Interventions
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Surgical repair of perforated peptic ulcer
Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty.
Surgical repair of perforated peptic ulcer
Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* The patients who are unable to understand and sign the informed consent form
* Age younger than 18
* The patients with a possibility of having trouble in communicating with or reaching the investigators during the first 6 weeks after surgery
* The patients who are considered as ASA class 4
* Shock on admission
* The patients who have serious negative factors for wound healing such as steroid usage, autoimmune diseases
* Pregnant
* Previous upper abdominal surgery
* The patients who are found to have a pathology other than perforated peptic ulcer during surgical exploration
* The patients who are found to have malignant ulcer during surgery or in postoperative period
* Concomitant bleeding peptic ulcers
* Peptic ulcer perforations with a diameter greater than 5 mm, which are not suitable for simple repair techniques
* Multiple perforated peptic ulcers
18 Years
ALL
No
Sponsors
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Bakirkoy Dr. Sadi Konuk Research and Training Hospital
OTHER_GOV
Responsible Party
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Murat Gonenc
M.D.
Principal Investigators
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Murat Gonenc, M.D.
Role: PRINCIPAL_INVESTIGATOR
Dr. Sadi Konuk Training and Research Hospital
Locations
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Dr. Sadi Konuk Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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FTS-240310
Identifier Type: -
Identifier Source: org_study_id
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