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CompletedNCT05147870Updated Dec 7, 2021

Outcome After Laparoscopic Surgery for Peptic Ulcer Perforation

An observational study in Intraabdominal Abscess After Procedure, Leakage and Pneumonia, sponsored by Chang Wei-Jung. Completed. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-07.

Sponsored by Chang Wei-Jung · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
150
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Intraabdominal Abscess After Procedure
  • Leakage
  • Pneumonia
  • Operation Wound; Infection

Keywords

  • Laparoscopic surgery
  • Perforated peptic ulcer
  • Peritoneal irrigation
  • Gauze wiping and suction
  • Intra-abdominal abscess
03

In context

Pneumonia

1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.

This study's enrollment of 150 is below the median of 252 across 535 observational studies indexed under Pneumonia.

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Lead sponsor

This is the only study on the registry with Chang Wei-Jung as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The patients with clinical diagnosis of PPU underwent laparoscopic repair surgery.

Exclusion criteria

Exclusion Criteria:

  • The patients received surgery in an open approach or underwent laparoscopy initially but then intraoperatively converted to laparotomy.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • Irrigation group

    Procedure: Peritoneal irrigation

  • Suction only group

    Procedure: Suction only

Interventions

  • ProcedurePeritoneal irrigation

    For patients allocated to the irrigation group, peritoneal lavage was performed at the surgeon's discretion based on surgical findings and preference.

  • ProcedureSuction only

    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.

06

What researchers measure

Primary outcomes

  1. Short-term outcome with wound infection, pneumonia, leakage, and intraabdominal abscess

    Complication grading used clavien dindo classification

    Time frame: Through hospitalization, an average of 8 days

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2013 to primary completion in Aug 2021, 103 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2021
First posted
Dec 7, 2021
StartActual
Jan 1, 2013
Primary completionActual
Aug 31, 2021
CompletionActual
Aug 31, 2021
Last update
Dec 7, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05147870
Lead sponsor
Chang Wei-Jung
Responsible party
Chang Wei-Jung (Sponsor-Investigator, Changhua Christian Hospital) — Sponsor-investigator
First posted
Dec 7, 2021
Start date
Jan 1, 2013
Primary completion
Aug 31, 2021
Completion
Aug 31, 2021
Last update
Dec 7, 2021

Study contacts

Lien-Cheng Tsao, M.D.
principal investigator · Changhua Christian Hospital, Changhua, 500, Taiwan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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