Fast-track Surgery for Perforated Peptic Ulcers

Study Overview
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Brief Summary
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The concept of enhanced recovery after surgery has become increasingly popular in elective abdominal surgeries. Yet, the role of this concept has not been described in emergency procedures. Therefore, this study aimed to investigate the feasibility of fast-track surgery in patients with perforated peptic ulcer.

Detailed Description
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The study is designed as a randomized, controlled clinical study. The patients with a preoperative diagnosis of perforated peptic ulcer will be recruited for the study. Among those, the patients with a definitive diagnosis of perforated peptic ulcer confirmed by surgical exploration will be included. 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.

Official Title
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The Feasibility of Fast-track Surgery for Perforated Peptic Ulcers. A Prospective Randomized Clinical Trial

Conditions
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Peptic Ulcer Perforation

Intervention / Treatment
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* Procedure: Surgical repair of perforated peptic ulcer
* Procedure: Surgical repair of perforated peptic ulcer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Perforated peptic ulcer located in the stomach or the duodenum Exclusion Criteria: The patients who refuse to join the study or to sign the informed consent form 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional surgery<br>The patients who will have a conventional surgical treatment will be included. | Procedure: Surgical repair of perforated peptic ulcer<br>* Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty.<br>|
| Active Comparator: Fast-track surgery<br>The patients who will have fast-track surgery will be included. | Procedure: Surgical repair of perforated peptic ulcer<br>* Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The morbidity and mortality rate |  | First 6 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | The participants will be followed for the duration of hospital stay. | An expected average of 5 days | 
| Readmission rate |  | The period within the first 6 weeks after surgery | 
| Endoscopic findings in control gastroscopy |  | At the end of 6 weeks after surgery |