Fast-track Surgery for Perforated Peptic Ulcers

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

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.

Study Overview

• Status: Completed
• Conditions: Peptic Ulcer Perforation
• Intervention / Treatment: Procedure: Surgical repair of 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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34147
    • Dr. Sadi Konuk Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional surgery; The patients who will have a conventional surgical treatment will be included.	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.
Active Comparator: Fast-track surgery; The patients who will have fast-track surgery will be included.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The morbidity and mortality rate	First 6 weeks after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Investigators: Principal Investigator: Murat Gonenc, M.D., Dr. Sadi Konuk Training and Research Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: June 11, 2012
• First Submitted That Met QC Criteria: June 14, 2012
• First Posted (Estimate): June 15, 2012

Study Record Updates

• Last Update Posted (Estimate): January 23, 2013
• Last Update Submitted That Met QC Criteria: January 22, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Ulcer; Peptic Ulcer; Peptic Ulcer Perforation
• Other Study ID Numbers: FTS-240310

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No