Clinical trial NCT01620671: Fast-track Surgery for Perforated Peptic Ulcers
Official title: The Feasibility of Fast-track Surgery for Perforated Peptic Ulcers. A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peptic Ulcer Perforation
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2012-06-15
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The morbidity and mortality rate
timeFrame: First 6 weeks after surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: An expected average of 5 days
measure: Readmission rate
timeFrame: The period within the first 6 weeks after surgery
measure: Endoscopic findings in control gastroscopy
timeFrame: At the end of 6 weeks after surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Dr. Sadi Konuk Training and Research Hospital
Study officials:
affiliation: Dr. Sadi Konuk Training and Research Hospital
name: Murat Gonenc, M.D.
role: PRINCIPAL_INVESTIGATOR
References: