Outcome After Laparoscopic Surgery for Peptic Ulcer Perforation
November 23, 2021 updated by: Chang Wei-Jung
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
150
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- The patients with clinical diagnosis of PPU underwent laparoscopic repair surgery.
Exclusion Criteria:
- The patients received surgery in an open approach or underwent laparoscopy initially but then intraoperatively converted to laparotomy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Irrigation group
|
For patients allocated to the irrigation group, peritoneal lavage was performed at the surgeon's discretion based on surgical findings and preference.
|
|
Suction only group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Through hospitalization, an average of 8 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lien-Cheng Tsao, M.D., Changhua Christian Hospital, Changhua, 500, Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2013
Primary Completion (Actual)
August 31, 2021
Study Completion (Actual)
August 31, 2021
Study Registration Dates
First Submitted
November 5, 2021
First Submitted That Met QC Criteria
November 23, 2021
First Posted (Actual)
December 7, 2021
Study Record Updates
Last Update Posted (Actual)
December 7, 2021
Last Update Submitted That Met QC Criteria
November 23, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.