Fast-track Surgery for Perforated Peptic Ulcers

• ClinicalTrials.gov Identifier: NCT01620671
• Recruitment Status: Completed
• First Posted: June 15, 2012
• Last Update Posted: January 23, 2013
• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Information provided by (Responsible Party): Murat Gonenc, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Tracking Information

• First Submitted Date: June 11, 2012
• First Posted Date: June 15, 2012
• Last Update Posted Date: January 23, 2013
• Study Start Date: May 2012
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 14, 2012): The morbidity and mortality rate [ Time Frame: First 6 weeks after surgery ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Peptic Ulcer Perforation

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 22, 2013): 61
• Original Estimated Enrollment (submitted: June 14, 2012): 60
• Actual Study Completion Date: January 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT01620671
• Other Study ID Numbers: FTS-240310
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Murat Gonenc, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Study Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Collaborators: Not Provided

Investigators

• 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