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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional surgery | Active Comparator | The patients who will have a conventional surgical treatment will be included. |
|
| Fast-track surgery | Active Comparator | The patients who will have fast-track surgery will be included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical repair of perforated peptic ulcer | Procedure | Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The morbidity and mortality rate | First 6 weeks after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murat Gonenc, M.D. | Dr. Sadi Konuk Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Sadi Konuk Training and Research Hospital | Istanbul | 34147 | Turkey (Türkiye) |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 15, 2013 | |
| Reset | Mar 18, 2013 | |
| Release | Mar 19, 2013 | |
| Reset | Apr 30, 2013 | |
| Release | Apr 30, 2013 | |
| Reset | Jun 4, 2013 | |
| Release | Jun 6, 2013 | |
| Reset | Jul 10, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 15, 2013 | Mar 18, 2013 | |||
| Mar 19, 2013 |
| ID | Term |
|---|---|
| D010439 | Peptic Ulcer Perforation |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Surgical repair of perforated peptic ulcer | Procedure | Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty. |
|
| Endoscopic findings in control gastroscopy | At the end of 6 weeks after surgery |
| Apr 30, 2013 |
| Apr 30, 2013 | Jun 4, 2013 |
| Jun 6, 2013 | Jul 10, 2013 |
| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |