Intraabdominal Abscess After ProcedureNCT05147870
Outcome After Laparoscopic Surgery for Peptic Ulcer Perforation
An observational study of Intraabdominal Abscess After Procedure and Leakage, run by Chang Wei-Jung.
Trial summary
Despite advances in laparoscopic surgery for perforated peptic ulcer (PPU), intra-abdominal abscess (IAA) is recognized as one of the commonly reported complications with relation to the extent of infectious abdominal contamination. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraabdominal Abscess After Procedure, Leakage, Pneumonia
- What is being tested?
- Peritoneal irrigation and Suction only
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 Aug 2021
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: From October 2012 to February 2021, 688 patients presented to the emergency room with a clinical diagnosis of PPU underwent surgery in our hospital. Five hundred and ninety-seven patients were operated in an open approach including 21 patients who were given laparoscopic surgery initially but then intraoperatively converted to laparotomy because the large perforation site cannot be primarily repaired, or the perforation site was difficult to identified or approached. The remaining 91 patients who underwent laparoscopic repair were included in this study.
Who may be able to join
- The patients with clinical diagnosis of PPU underwent laparoscopic repair surgery.
Who cannot join
- The patients received surgery in an open approach or underwent laparoscopy initially but then intraoperatively converted to laparotomy.
About this study
Official title: Whether Peritoneal Irrigation Intra-operatively Effects on the Outcome After Laparoscopic Surgery for Peptic Ulcer Perforation
Despite advances in laparoscopic surgery for perforated peptic ulcer (PPU), intra-abdominal abscess (IAA) is recognized as one of the commonly reported complications with relation to the extent of infectious abdominal contamination. Herein, the investigators report their experience of laparoscopic surgery for PPU with/without peritoneal irrigation and discuss postoperative outcome. The investigators retrospectively examined the electronic medical records of the patients who underwent laparoscopic surgery for perforated peptic ulcer at a single medical center in Taiwan between January 2013 and August 2021. Retrospectively, the investigators would include those patients with clinical diagnosis of PPU who underwent emergent laparoscopic surgery. The patients with previous abdominal surgery, pathologic confirmed malignant ulcer perforation or concomitant ulcer bleeding were excluded. The investigators focused on post-operative complications and outcome after laparoscopic surgery with or without peritoneal irrigation. This information can be important in improving surgical options with respect to risk and potential benefits in this setting.
- Being tested
- Peritoneal irrigation, Suction only
- Keywords
- Laparoscopic surgery, Perforated peptic ulcer, Peritoneal irrigation, Gauze wiping and suction, Intra-abdominal abscess
- Medical subject headings
- Pneumonia, Surgical Wound Infection, Peptic Ulcer Perforation, Abdominal Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal irrigationProcedure or surgery
For patients allocated to the irrigation group, peritoneal lavage was performed at the surgeon's discretion based on surgical findings and preference.
Suction onlyProcedure or surgery
In the suction only group, one surgical gauze each was placed in the splenophrenic space and Morison's pouch to soak up any remaining purulent fluid followed by turning the patient into the Trendelenburg position for inspection of the lower abdominal cavity. Any interloop adhesions were carefully divided and the gauze-wiping maneuver was used to soak up the residual peritoneal fluid, and all bowel loops were investigated to the root of the mesentery.
| Study group | Role | What they receive |
|---|---|---|
| Irrigation group | Not described Receives: Procedure: Peritoneal irrigation | |
| Suction only group | Not described Receives: Procedure: Suction only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term outcome with wound infection, pneumonia, leakage, and intraabdominal abscess
Complication grading used clavien dindo classification
Measured: Through hospitalization, an average of 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start1 Jan 2013
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraabdominal Abscess After ProcedureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Wei-Jung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chang Wei-Jung, Changhua Christian Hospital
- Investigators
- Lien-Cheng Tsao, M.D., Principal investigator, Changhua Christian Hospital, Changhua, 500, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147870
- Sponsor's protocol ID
- 201021
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whether Peritoneal Irrigation Intra-operatively Effects on the Outcome After Laparoscopic Surgery for Peptic Ulcer Perforation
- ClinicalTrials.gov ID
- NCT05147870
- Acronym / sponsor ID
- 201021
- Keywords
- Laparoscopic surgery, Perforated peptic ulcer, Peritoneal irrigation, Gauze wiping and suction, Intra-abdominal abscess
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chang Wei-JungUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 7 Dec 2021 (actual)
- 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.
Despite advances in laparoscopic surgery for perforated peptic ulcer (PPU), intra-abdominal abscess (IAA) is recognized as one of the commonly reported complications with relation to the extent of infectious abdominal contamination. Herein, the investigators report their experience of laparoscopic surgery for PPU with/without peritoneal irrigation and discuss postoperative outcome. The investigators retrospectively examined the electronic medical records of the patients who underwent laparoscopic surgery for perforated peptic ulcer at a single medical center in Taiwan between January 2013 and August 2021. Retrospectively, the investigators would include those patients with clinical diagnosis of PPU who underwent emergent laparoscopic surgery. The patients with previous abdominal surgery, pathologic confirmed malignant ulcer perforation or concomitant ulcer bleeding were excluded. The investigators focused on post-operative complications and outcome after laparoscopic surgery with or without peritoneal irrigation. This information can be important in improving surgical options with respect to risk and potential benefits in this setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irrigation group | – | Procedure: Peritoneal irrigation |
| Suction only group | – | Procedure: Suction only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- From October 2012 to February 2021, 688 patients presented to the emergency room with a clinical diagnosis of PPU underwent surgery in our hospital. Five hundred and ninety-seven patients were operated in an open approach including 21 patients who were given laparoscopic surgery initially but then intraoperatively converted to laparotomy because the large perforation site cannot be primarily repaired, or the perforation site was difficult to identified or approached. The remaining 91 patients who underwent laparoscopic repair were included in this study.
Key inclusion criteria (1 listed)
- The patients with clinical diagnosis of PPU underwent laparoscopic repair surgery.
Key exclusion criteria (1 listed)
- The patients received surgery in an open approach or underwent laparoscopy initially but then intraoperatively converted to laparotomy.
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 |
|---|---|---|
| Peritoneal irrigationFor patients allocated to the irrigation group, peritoneal lavage was performed at the surgeon's discretion based on surgical findings and preference. | Procedure or surgery | Irrigation group |
| Suction onlyIn the suction only group, one surgical gauze each was placed in the splenophrenic space and Morison's pouch to soak up any remaining purulent fluid followed by turning the patient into the Trendelenburg position for inspection of the lower abdominal cavity. Any interloop adhesions were carefully divided and the gauze-wiping maneuver was used to soak up the residual peritoneal fluid, and all bowel loops were investigated to the root of the mesentery. | Procedure or surgery | Suction only group |
Primary outcome
Short-term outcome with wound infection, pneumonia, leakage, and intraabdominal abscess
Time frame: Through hospitalization, an average of 8 days
Complication grading used clavien dindo classification
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 7 Dec 2021.
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.
Lien-Cheng Tsao, M.D. principal investigator
Changhua Christian Hospital, Changhua, 500, Taiwan
Questions about this trial
What is this clinical trial studying?
An observational study of Intraabdominal Abscess After Procedure and Leakage, run by Chang Wei-Jung.
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 1 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 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Short-term outcome with wound infection, pneumonia, leakage, and intraabdominal abscess (time frame: Through hospitalization, an average of 8 days). 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 7 Dec 2021.