Outcome After Laparoscopic Surgery for Peptic Ulcer Perforation

NCT05147870 | Completed DMC

• 1 other identifier: 201021
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Complication grading used clavien dindo classification

  Through hospitalization, an average of 8 days

Study Arms (2)

Irrigation group

Procedure: Peritoneal irrigation

Suction only group

Procedure: Suction only

Interventions

Peritoneal irrigation PROCEDURE

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

Irrigation group

Suction only PROCEDURE

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.

Suction only group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Wei-Jung: lead

MeSH Terms

Conditions

Pneumonia; Surgical Wound Infection; Peptic Ulcer Perforation; Abdominal Abscess

Interventions

Peritoneal Lavage

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Abscess; Suppuration

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• Lien-Cheng Tsao, M.D.

  Changhua Christian Hospital, Changhua, 500, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 7, 2021
• Study Start: January 1, 2013
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-11