Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06182488
Status:
RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-11-21
Brief Title:
Enhanced Recovery After Surgery ERAS in Patients Undergoing Emergency Laparotomy
Sponsor:
Tianjin Medical University
Organization:
Tianjin Medical University
Study Overview
Official Title:
Safety and Efficacy of Enhanced Recovery After Surgery ERAS in Patients Undergoing Emergency Laparotomy A Single Center Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERAS
Brief 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
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
Detailed 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 ie 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 surgeons 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
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 ie 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 surgeons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-YLS-010 | OTHER | Tianjin Hospital | None |