Fast-track Surgery for Perforated Peptic Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Murat Gonenc, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT01620671
First received: June 11, 2012
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Peptic Ulcer Perforation
Procedure: Surgical repair of perforated peptic ulcer
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Feasibility of Fast-track Surgery for Perforated Peptic Ulcers. A Prospective Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital:

Primary Outcome Measures:
  • The morbidity and mortality rate [ Time Frame: First 6 weeks after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: An expected average of 5 days ] [ Designated as safety issue: No ]
    The participants will be followed for the duration of hospital stay.

  • Readmission rate [ Time Frame: The period within the first 6 weeks after surgery ] [ Designated as safety issue: No ]
  • Endoscopic findings in control gastroscopy [ Time Frame: At the end of 6 weeks after surgery ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: May 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620671

Locations
Turkey
Dr. Sadi Konuk Training and Research Hospital
Istanbul, Turkey, 34147
Sponsors and Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Investigators
Principal Investigator: Murat Gonenc, M.D. Dr. Sadi Konuk Training and Research Hospital
  More Information

No publications provided

Responsible Party: Murat Gonenc, M.D., Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT01620671     History of Changes
Other Study ID Numbers: FTS-240310
Study First Received: June 11, 2012
Last Updated: January 22, 2013
Health Authority: Turkey: Ethics Committee

Additional relevant MeSH terms:
Peptic Ulcer
Peptic Ulcer Perforation
Ulcer
Digestive System Diseases
Duodenal Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Stomach Diseases

ClinicalTrials.gov processed this record on October 23, 2014