Fast-track Surgery for Perforated Peptic Ulcers

Peptic Ulcer Perforation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620671
• Other study ID #: FTS-240310
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2012
• Last updated: January 22, 2013
• Start date: May 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peptic Ulcer
• Peptic Ulcer Perforation
• Ulcer

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Turkey	Dr. Sadi Konuk Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The morbidity and mortality rate		First 6 weeks after surgery
Secondary	Length of hospital stay	The participants will be followed for the duration of hospital stay.	An expected average of 5 days
Secondary	Readmission rate		The period within the first 6 weeks after surgery
Secondary	Endoscopic findings in control gastroscopy		At the end of 6 weeks after surgery