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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-YLS-010 | Other Identifier | Tianjin Hospital |
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| Name | Class |
|---|---|
| Tianjin Hospital | OTHER |
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The goal of this clinical trial is to test the safety and effectiveness of the ERAS protocols compared to a conventional care protocols in patients who received emergency laparotomy. The main question it aims to answer are:
• Can the ERAS protocols be used safely and effectively in patients undergoing emergency laparotomy? Participants will be randomised into the ERAS group and the conventional group and will be given the ERAS protocols and the conventional protocols in the perioperative period.
Researchers will compare the ERAS group with the conventional group to see if the ERAS programme is effective.
Since Kehlet first proposed enhanced recovery after surgery (ERAS) protocols in the 1990s, researchers have been widely adopted. Preoperative counseling, standardized anesthesia management protocols, more optimal postoperative analgesic regimens, restriction of intubation and catheterization, early postoperative mobilization, and early oral intake of food are all part of ERAS programs. These programs began in colorectal surgery and have now been expanded to other surgical specialties. Several studies have shown that patients benefit from ERAS programs, including reduced pain, faster return to bowel function, shorter hospital stays, and lower health care costs. However, investigators found that ERAS programs are rarely used for emergency surgery.
Emergency surgery is the treatment of choice for acute abdominal conditions such as traumatic liver rupture, traumatic splenic rupture, and complete bowel obstruction. Nevertheless, investigators found that most clinical studies of ERAS excluded patients who underwent emergency surgery. This is because most researchers probably believe that emergency surgery does not allow enough time for ERAS-related preoperative preparation. In fact, some ERAS programs can be used for emergency surgery, such as the anesthetic modality of combined anesthesia, postoperative multimodal analgesia, earlier postoperative oral feeding and ambulation, and earlier removal of invasive catheters. However, few studies have focused on the use of ERAS in emergency surgery.
The present study is a randomized controlled trial evaluating the safety and efficacy of an ERAS program in emergency abdominal surgery. Investigators hypothesized that an ERAS program could be implemented into emergency surgery and reduce postoperative recovery time without increasing the complication rate and readmission rate (<30 days).
The standard operating procedures for the study are as follows:
In the ERAS group, an epidural catheter was placed in the lumbar 3-4 space before surgery to facilitate intraoperative epidural anaesthesia and postoperative analgesia. At the same time, ultrasound-guided internal jugular vein (IJV) cannulation was performed to monitor central venous pressure (CVP). CVP-guided infusion, i.e., goal-directed fluid therapy, was maintained at a CVP of 8-10 cm of saline. Depending on the urinary output, blood pressure, heart rate, and clinical signs of dehydration, fluids were administered according to an institutional care plan in the routine care group. Dexamethasone 4 mg IV was given shortly before induction of anaesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERAS Group | Experimental | According to the ERAS guidelines, the ERAS group received ERAS protocol. |
|
| Conventional group | Other | Conventional perioperative interventions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERAS protocols | Other | ERAS protocols for emergency abdominal surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative recovery time | Postoperative recovery time that meets the relevant definitions in this study | From enrollment to the end of treatment at 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of postoperative complications | Percentage of participants who met the recovery condition after surgery as a percentage of total participants | From enrollment to the end of treatment at 2 weeks |
| The time of first postoperative flatus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianing Lu, MD | Contact | 86-022-60910136 | lujianing2006@163.com | |
| Hong Zheng, MD | Contact | zhenghongyx@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Zheng, MD | Tianjin First Central Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 17, 2024 | |
| Reset | Sep 13, 2024 | |
| Release | Nov 20, 2024 | |
| Reset | Jan 8, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2023 | Dec 4, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 20, 2023 | Dec 12, 2023 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 17, 2024 | Sep 13, 2024 | |||
| Nov 20, 2024 |
| ID | Term |
|---|---|
| D000006 | Abdomen, Acute |
| D000007 | Abdominal Injuries |
| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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A single center randomized controlled trial
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| Conventional protocols |
| Other |
Conventional protocols for emergency abdominal surgery |
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The time of first postoperative flatus
| From enrollment to the end of treatment at 2 weeks |
| The time to tolerate semi-fluid diet after surgery | The time to tolerate semi-fluid diet after surgery | From enrollment to the end of treatment at 2 weeks |
| The time to tolerate soft food after surgery | The time to tolerate soft food after surgery | From enrollment to the end of treatment at 2 weeks |
| The rate of readmission (in 30 days) | Percentage of participants who were readmitted to the hospital within 30 days after surgery for an adverse event related to this procedure as a percentage of total participants | From enrollment to the end of treatment at 2 weeks |
| Jan 8, 2025 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D014947 | Wounds and Injuries |