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

Primary Purpose

Hospital Stay, Hospital Cost

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

ERAS treatment

About this trial

This is an interventional treatment trial for Hospital Stay focused on measuring Perforated peptic ulcer, Enhanced recovery after surgery, Laparoscopic repair, Complications

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Perforated ulcer less than 10 mm in size
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

Sites / Locations

Beijing Chaoyang Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard postoperative care group

ERAS group

Arm Description

Patients received standard postoperative care as ususal.

Patients received postoperative ERAS treatment.

Outcomes

Primary Outcome Measures

Hospital stay

The time patients stay in hospital.

Secondary Outcome Measures

Full Information

NCT ID

NCT04039646

First Posted

July 28, 2019

Last Updated

February 4, 2021

Sponsor

Beijing Chao Yang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04039646

Brief Title

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

Official Title

Enhanced Recovery After Surgery in Patients With Perforated Peptic Ulcer Disease Who Underwent Laparoscopic Repair, a Randomised Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Chao Yang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hospital Stay, Hospital Cost

Keywords

Perforated peptic ulcer, Enhanced recovery after surgery, Laparoscopic repair, Complications

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard postoperative care group

Arm Type

Active Comparator

Arm Description

Patients received standard postoperative care as ususal.

Arm Title

ERAS group

Arm Type

Experimental

Arm Description

Patients received postoperative ERAS treatment.

Intervention Type

Combination Product

Intervention Name(s)

ERAS treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Hospital stay

Description

The time patients stay in hospital.

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Perforated ulcer less than 10 mm in size 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jia Gang Han, MD

Phone

+86013522867841

hjg211@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Hua Tian

Organizational Affiliation

Ethics center, Beijing Chaoyang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Chaoyang Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhen Jun Wang, M.D.

Phone

86-013601393711

wzhj611@163.com

First Name & Middle Initial & Last Name & Degree

Zhen Jun Wang

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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