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Fast-track Surgery for Perforated Peptic Ulcers

Primary Purpose

Peptic Ulcer Perforation

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Surgical repair of perforated peptic ulcer
Surgical repair of perforated peptic ulcer
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peptic Ulcer Perforation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dr. Sadi Konuk Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional surgery

Fast-track surgery

Arm Description

The patients who will have a conventional surgical treatment will be included.

The patients who will have fast-track surgery will be included.

Outcomes

Primary Outcome Measures

The morbidity and mortality rate

Secondary Outcome Measures

Length of hospital stay
The participants will be followed for the duration of hospital stay.
Readmission rate
Endoscopic findings in control gastroscopy

Full Information

First Posted
June 11, 2012
Last Updated
January 22, 2013
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01620671
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer Perforation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional surgery
Arm Type
Active Comparator
Arm Description
The patients who will have a conventional surgical treatment will be included.
Arm Title
Fast-track surgery
Arm Type
Active Comparator
Arm Description
The patients who will have fast-track surgery will be included.
Intervention Type
Procedure
Intervention Name(s)
Surgical repair of perforated peptic ulcer
Intervention Description
Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty.
Intervention Type
Procedure
Intervention Name(s)
Surgical repair of perforated peptic ulcer
Intervention Description
Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty.
Primary Outcome Measure Information:
Title
The morbidity and mortality rate
Time Frame
First 6 weeks after surgery
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
The participants will be followed for the duration of hospital stay.
Time Frame
An expected average of 5 days
Title
Readmission rate
Time Frame
The period within the first 6 weeks after surgery
Title
Endoscopic findings in control gastroscopy
Time Frame
At the end of 6 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat Gonenc, M.D.
Organizational Affiliation
Dr. Sadi Konuk Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Sadi Konuk Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey

12. IPD Sharing Statement

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Fast-track Surgery for Perforated Peptic Ulcers

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