Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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: - Participants will be randomised into the ERAS group and the conventional group. - Preoperative care: A number of preoperative protocols were similar in both groups, including (1) surgical risk assessment; (2) preoperative placement of a nasogastric tube (NG); (3) preoperative administration of crystalloid fluids to replenish blood volume; (4) empiric antibiotics and acid-reducing therapy administered intravenously; and (5) intravenous analgesia. 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. - Intraoperative care: All patients underwent emergency open surgery. Appropriate surgical incisions were selected based on adequate provision of good surgical vision and surgical space. If intra-abdominal fluid was found, it was aspirated and sent for bacterial culture. The final decision on the surgical approach is based on the surgeon's opinion and intraoperative findings. If anastomosis was deemed unsafe, an ileostomy without anastomosis was performed. Table 1 shows the changes in the anaesthesia regimen in the ERAS group. The anesthesiologist decided on the anaesthesia for the conventional group. In the ERAS group, an experienced surgeon set up an abdominal drain as needed during the procedure. In the conventional care group, an abdominal drain was routinely placed. - Postoperative care: Patients in the ERAS group were asked to start simple bed activities, such as moving both lower limbs, on the day of surgery (POD-0), provided that the epidural catheter was secure. At POD-1, patients were asked to sit for at least 2 hours and then get out of bed after the epidural catheter was removed at POD-2. In the conventional group, patients were encouraged to be active at POD-2, starting with simple bed activities and gradually transitioning to normal walking without any specific requirements. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06182488
Study type Interventional
Source Tianjin Medical University
Contact Jianing Lu, MD
Phone 86-022-60910136
Email lujianing2006@163.com
Status Recruiting
Phase N/A
Start date November 1, 2023
Completion date May 30, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04196244 - Intravenous Contrast Computed Tomography Versus Native Computed Tomography in Patients With Acute Abdomen and Impaired Renal Function Phase 4
Withdrawn NCT01044173 - Plain Magnetic Resonance (MR) in the Assessment of Patients With Acute Abdomen N/A
Active, not recruiting NCT06154603 - Upper Gastrointestinal Perforations: a Nationwide Registry-based Study
Completed NCT05295251 - The Commonest Medical, Surgical, and Oncological Causes of Acute Abdomen in Adults With COVID-19. A Prospective Observational Study.
Not yet recruiting NCT05407922 - Laparoscopic Value in the Management of Acute Abdomen During Pregnancy
Recruiting NCT02467959 - Diagnostic Accuracy of Emergency Physician Performed Bedside Ultrasound in Suspected Acute Appendicitis N/A
Completed NCT01911702 - Different Fluidic Strategy in Patients With Acute Abdomen : The Sure Volume Phase 2
Completed NCT00870766 - Computer Tomography (CT) Trial of Acute Abdomen N/A
Completed NCT05419440 - Laparoscopic Drainage Versus Interventional Radiology In Management Of Appendicular Abscess : N/A
Completed NCT05004532 - Transversus Abdominis Plane Block in Acute Appendicitis Pain Managment
Completed NCT05591495 - The Role of Laparoscopy in Upper Abdominal Surgical Emergencies in Adults: A Retrospective Observational Study.
Completed NCT03262025 - Primary Cecal Pathologies Presenting as Acute Abdomen N/A
Active, not recruiting NCT03549624 - Standardized Perioperative Management of Patients Operated With Acute Abdominal Surgery in a High-risk Emergency Setting
Recruiting NCT06320886 - Role of Ultrasonography in Acute Abdomen in Adults in Correlation to Computed Tomography Scan
Completed NCT01982708 - A Prospective Study of a Haptic Device Evaluation of the Acute Abdomen N/A
Not yet recruiting NCT04577339 - The Best Care for Abdominal Emergencies Study
Completed NCT04662242 - The Prognostic Impact of Selenium On Critical Surgical Patients Phase 4
Completed NCT04966780 - Refeeding Like Syndrome in Acute Disease
Enrolling by invitation NCT03096665 - Effectiveness of Point of Care Blood Analysis Obtained From Skin Puncture Blood N/A