Outcome After Laparoscopic Surgery for Peptic Ulcer Perforation

Sponsor
Chang Wei-Jung (Other)
Overall Status
Completed
CT.gov ID
NCT05147870
Collaborator
(none)
150
104

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Peritoneal irrigation
  • Procedure: Suction only

Study Design

Study Type:
Observational
Actual Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Whether Peritoneal Irrigation Intra-operatively Effects on the Outcome After Laparoscopic Surgery for Peptic Ulcer Perforation
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Aug 31, 2021
Actual Study Completion Date :
Aug 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Irrigation group

Procedure: Peritoneal irrigation
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

Procedure: Suction 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.

Outcome Measures

Primary Outcome Measures

  1. Short-term outcome with wound infection, pneumonia, leakage, and intraabdominal abscess [Through hospitalization, an average of 8 days]

    Complication grading used clavien dindo classification

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chang Wei-Jung

Investigators

  • Principal Investigator: Lien-Cheng Tsao, M.D., Changhua Christian Hospital, Changhua, 500, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Wei-Jung, Sponsor-Investigator, Changhua Christian Hospital
ClinicalTrials.gov Identifier:
NCT05147870
Other Study ID Numbers:
  • 201021
First Posted:
Dec 7, 2021
Last Update Posted:
Dec 7, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chang Wei-Jung, Sponsor-Investigator, Changhua Christian Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 7, 2021