Clinical Trial: Fast-track Surgery for Perforated Peptic Ulcers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Feasibility of Fast-track Surgery for Perforated Peptic Ulcers. A Prospective Randomized Clinical Trial
Brief Summary: 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 Summary:
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.
Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Current Primary Outcome: The morbidity and mortality rate [ Time Frame: First 6 weeks after surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Length of hospital stay [ Time Frame: An expected average of 5 days ]The participants will be followed for the duration of hospital stay.
- Readmission rate [ Time Frame: The period within the first 6 weeks after surgery ]
- Endoscopic findings in control gastroscopy [ Time Frame: At the end of 6 weeks after surgery ]
Original Secondary Outcome: Same as current
Information By: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Dates:
Date Received: June 11, 2012
Date Started: May 2012
Date Completion:
Last Updated: January 22, 2013
Last Verified: January 2013
