Peptic Ulcer PerforationPhase 4NCT01620671
Fast-track Surgery for Perforated Peptic Ulcers
A Phase 4 study testing Surgical repair of perforated peptic ulcer in people with Peptic Ulcer Perforation, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer Perforation
- What is being tested?
- Surgical repair of perforated peptic ulcer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2012to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Perforated peptic ulcer located in the stomach or the duodenum
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Sadi Konuk Training and Research Hospital
Istanbul, 34147
About this study
Official title: The Feasibility of Fast-track Surgery for Perforated Peptic Ulcers. A Prospective Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Peptic Ulcer Perforation
- Being tested
- Surgical repair of perforated peptic ulcer
- Medical subject headings
- Peptic Ulcer Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical repair of perforated peptic ulcerProcedure or surgery
Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty.
Surgical repair of perforated peptic ulcerProcedure or surgery
Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty.
| Study group | Role | What they receive |
|---|---|---|
| Conventional surgery | Active comparator | The patients who will have a conventional surgical treatment will be included. Receives: Procedure: Surgical repair of perforated peptic ulcer |
| Fast-track surgery | Active comparator | The patients who will have fast-track surgery will be included. Receives: Procedure: Surgical repair of perforated peptic ulcer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The morbidity and mortality rate
Measured: First 6 weeks after surgery
Secondary outcomes (3)
Length of hospital stay
The participants will be followed for the duration of hospital stay.
Measured: An expected average of 5 days
Readmission rate
Measured: The period within the first 6 weeks after surgery
Endoscopic findings in control gastroscopy
Measured: At the end of 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Murat Gonenc, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Murat Gonenc, M.D., Principal investigator, Dr. Sadi Konuk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620671
- Sponsor's protocol ID
- FTS-240310
- Status last verified
- Jan 2013
- First submitted
- 11 Jun 2012
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Fast-track Surgery for Perforated Peptic Ulcers. A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01620671
- Acronym / sponsor ID
- FTS-240310
- Conditions
- Peptic Ulcer Perforation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- May 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 15 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional surgery | Active comparator | Procedure: Surgical repair of perforated peptic ulcerThe patients who will have a conventional surgical treatment will be included. |
| Fast-track surgery | Active comparator | Procedure: Surgical repair of perforated peptic ulcerThe patients who will have fast-track surgery will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Perforated peptic ulcer located in the stomach or the duodenum
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical repair of perforated peptic ulcerPerforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty. | Procedure or surgery | Conventional surgery |
| Surgical repair of perforated peptic ulcerPerforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty. | Procedure or surgery | Fast-track surgery |
Primary outcome
The morbidity and mortality rate
Time frame: First 6 weeks after surgery
3 secondary outcomes
Length of hospital stay
Time frame: An expected average of 5 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
Related trials for Peptic Ulcer Perforation
Not yet recruiting
Laparoscopic Falciform Ligament Flap Versus Omental Patch for Perforated Peptic Ulcers
Perforated Peptic Ulcer, Peptic Ulcer Perforation
Not yet recruiting
Falciformopexy for Treatment Perforated Peptic Ulcer.
Perforated Peptic Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murat Gonenc, M.D. principal investigator
Dr. Sadi Konuk Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surgical repair of perforated peptic ulcer in people with Peptic Ulcer Perforation, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The morbidity and mortality rate (time frame: First 6 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.