Fast-track Surgery for Perforated Peptic Ulcers

Phase 4

Completed

• Conditions: Peptic Ulcer Perforation

• Registration Number: NCT01620671
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-15
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The morbidity and mortality rate	First 6 weeks after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dr. Sadi Konuk Training and Research Hospital; 🇹🇷 Istanbul, Turkey