Fast-track Surgery for Perforated Peptic Ulcers

NCT01620671 | Completed Phase 4 DMC

• 1 other identifier: FTS-240310
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Peptic Ulcer Perforation

Outcome Measures

Primary Outcomes (1)

• The morbidity and mortality rate

  First 6 weeks after surgery

Secondary Outcomes (3)

• Length 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

Study Arms (2)

Conventional surgery

ACTIVE COMPARATOR

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

Procedure: Surgical repair of perforated peptic ulcer

Fast-track surgery

ACTIVE COMPARATOR

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

Procedure: Surgical repair of perforated peptic ulcer

Interventions

Surgical repair of perforated peptic ulcer PROCEDURE

Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty.

Conventional surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Perforated peptic ulcer located in the stomach or the duodenum

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peptic Ulcer Perforation

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Murat Gonenc, M.D.

  Dr. Sadi Konuk Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 15, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

TU (1)