ERAS in Patients With Perforated Peptic Ulcer Disease Who Underwent Laparoscopic Repair

Overview

Perforated peptic ulcer (PPU) is a frequent emergency condition worldwide with associated mortality up to 30%. Open procedures have in the most part been replaced by laparoscopic techniques. The standard postoperative management of PPUD patients is predominantly based on traditional practices. The aim of this randomized controlled clinical trial was to investigate the feasibility of enhanced postoperative recovery pathways in patients who underwent laparoscopic repair for Perforated peptic ulcer.

Full Title of Study: “Enhanced Recovery After Surgery in Patients With Perforated Peptic Ulcer Disease Who Underwent Laparoscopic Repair, a Randomised Controlled Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2021

Detailed Description

Perforated peptic ulcer (PPU) is a frequent emergency condition worldwide with associated mortality up to 30%. Open procedures have in the most part been replaced by laparoscopic techniques. The standard postoperative management of PPUD patients is predominantly based on traditional practices. Randomization will be made at the end of the surgical procedure. Patients will be included in groups 1 or2. Group 1 is the control group and will receive standard postoperative care, and group 2 is the ERAS group.The aim of this randomized controlled clinical trial was to investigate the feasibility of ERAS in patients who underwent laparoscopic repair for Perforated peptic ulcer.

Interventions

  • Combination Product: ERAS treatment
    • The ERAS group had an enhanced postoperative recovery protocol. The gastric content was aspirated via the nasogastric tube by the anesthesiologist at the end of the procedure, and the nasogastric tube was withdrawn in the operating room immediately after the patient had recovered from anesthesia. and also early feeding and move.

Arms, Groups and Cohorts

  • Active Comparator: Standard postoperative care group
    • Patients received standard postoperative care as ususal.
  • Experimental: ERAS group
    • Patients received postoperative ERAS treatment.

Clinical Trial Outcome Measures

Primary Measures

  • Hospital stay
    • Time Frame: 30 days
    • The time patients stay in hospital.

Participating in This Clinical Trial

Inclusion Criteria

1. Perforated ulcer less than 10 mm in size 2. Patients received laprascopic repair Exclusion Criteria:

- 1. refusal to join the study or sign the informed consent form 3. age younger than 18 years 3.the presence of any psychiatric or neurologic disease 4. class 3 and 4 surgical patients according to the classification of The American Society of Anesthesiologists 5. septic shock on admission 6. pregnancy 7. multiple perforated peptic ulcers 8. spontaneously sealed-off perforated ulcers that were diagnosed either preoperatively or during surgery and that did not require surgical repair 9.conversion to open technique 10. perforated ulcers that were not amenable to Graham patch repair because of size or technical considerations

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beijing Chao Yang Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhen Jun Wang, Chairman of General Surgery – Beijing Chao Yang Hospital
  • Overall Official(s)
    • Li Hua Tian, Principal Investigator, Ethics center, Beijing Chaoyang Hospital
  • Overall Contact(s)
    • Jia Gang Han, MD, +86013522867841, hjg211@163.com

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