Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fast-track Surgery for Perforated Peptic Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01620671
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
Murat Gonenc, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Tracking Information
First Submitted Date  ICMJE June 11, 2012
First Posted Date  ICMJE June 15, 2012
Last Update Posted Date January 23, 2013
Study Start Date  ICMJE May 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2012)
The morbidity and mortality rate [ Time Frame: First 6 weeks after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2012)
  • Length of hospital stay [ Time Frame: An expected average of 5 days ]
    The participants will be followed for the duration of hospital stay.
  • Readmission rate [ Time Frame: The period within the first 6 weeks after surgery ]
  • Endoscopic findings in control gastroscopy [ Time Frame: At the end of 6 weeks after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fast-track Surgery for Perforated Peptic Ulcers
Official Title  ICMJE The Feasibility of Fast-track Surgery for Perforated Peptic Ulcers. A Prospective Randomized Clinical Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peptic Ulcer Perforation
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: Conventional surgery
    The patients who will have a conventional surgical treatment will be included.
    Intervention: Procedure: Surgical repair of perforated peptic ulcer
  • Active Comparator: Fast-track surgery
    The patients who will have fast-track surgery will be included.
    Intervention: Procedure: Surgical repair of perforated peptic ulcer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2013)
61
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2012)
60
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01620671
Other Study ID Numbers  ICMJE FTS-240310
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Murat Gonenc, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study Sponsor  ICMJE Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Murat Gonenc, M.D. Dr. Sadi Konuk Training and Research Hospital
PRS Account Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP