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Completed

NCT Number: NCT01620671

Fast-track Surgery for Perforated Peptic Ulcers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The morbidity and mortality rate

    Time frame: First 6 weeks after surgery

Secondary outcomes

  1. Length of hospital stay

    Time frame: An expected average of 5 days

    The participants will be followed for the duration of hospital stay.

  2. Readmission rate

    Time frame: The period within the first 6 weeks after surgery

  3. Endoscopic findings in control gastroscopy

    Time frame: At the end of 6 weeks after surgery

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

The Feasibility of Fast-track Surgery for Perforated Peptic Ulcers. A Prospective Randomized Clinical Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 15, 2012
Registry last updated
Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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