Fast-track Surgery for Perforated Peptic Ulcers

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status and phase

Completed

Phase 4

Conditions

Peptic Ulcer Perforation

Treatments

Procedure: Surgical repair of perforated peptic ulcer

Study type

Interventional

Funder types

Other

Identifiers

NCT01620671

FTS-240310

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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