Acute AbdomenERASNCT06182488
Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Emergency Laparotomy
A study testing ERAS protocols and Conventional protocols in people with Acute Abdomen and Abdominal Trauma, run by Tianjin Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Abdomen, Abdominal Trauma, Emergency Surgery
- What is being tested?
- ERAS protocols and Conventional protocols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages 18-70,
- Patients who completed the preoperative examination and preoperative diagnosis within 4 hours after admission for acute abdomen diseases,
- Required emergency surgery within 6 hours from surgeon encounter.
Who cannot join
- Patients who refused to be enrolled in this study;
- Patients with any psychiatric or neurological disorders;
- Pseptic shock at admission;
- Duration of symptoms more than five days;
- Patients with contraindications to the placement of lumbar epidural catheters, such as coagulation disorders, severe sepsis, etc.;
- Presence of preoperative factors affecting wound healing (e.g. long-term steroid use);
- Patients with extra-abdominal injuries or terminal malignancy, or patients requiring damage control surgery;
- Patients found intraoperatively to require any procedure other than splenectomy, partial hepatectomy or liver repair, bowel resection and anastomosis, laparoscopic cholecystectomy and appendectomy, and gastrointestinal perforation repair.
Trial locations and contacts
1 site in 1 country.
Hong Zheng, MD contact
China1 site, 1 recruiting
- Recruiting
Tianjin Hospital
Tianjin, Tianjin Municipality, 300000
Bin Dai, +86 138 2166 0137, 490621209@qq.com
Yan Zhuang, MD
About this study
Official title: Safety and Efficacy of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Emergency Laparotomy: A Single Center Randomized Controlled Trial
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.
Read the 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, 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.
- Conditions
- Acute Abdomen, Abdominal Trauma, Emergency Surgery
- Being tested
- ERAS protocols, Conventional protocols
- Keywords
- Enhanced recovery after surgery (ERAS), Emergency surgery, Acute abdominal disease, Combined anesthesia, Goal-directed fluid therapy
- Medical subject headings
- Abdomen, Acute, Abdominal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS protocolsOther
ERAS protocols for emergency abdominal surgery
Conventional protocolsOther
Conventional protocols for emergency abdominal surgery
| Study group | Role | What they receive |
|---|---|---|
| ERAS Group | Experimental | According to the ERAS guidelines, the ERAS group received ERAS protocol. Receives: Other: ERAS protocols |
| Conventional group | Other | Conventional perioperative interventions Receives: Other: Conventional protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative recovery time
Postoperative recovery time that meets the relevant definitions in this study
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (5)
the rate of postoperative complications
Percentage of participants who met the recovery condition after surgery as a percentage of total participants
Measured: From enrollment to the end of treatment at 2 weeks
The time of first postoperative flatus
The time of first postoperative flatus
Measured: 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
Measured: 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
Measured: 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
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start1 Nov 2023
- Primary completion30 Nov 2023
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AbdomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single center randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Hospital
- Responsible party
- Principal investigator, Jianing Lu, Tianjin Medical University
- Investigators
- Hong Zheng, MD, Study chair, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182488
- Sponsor's protocol ID
- 2023-YLS-010
- Other IDs
- 2023-YLS-010
- Acronym
- ERAS
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Emergency Laparotomy: A Single Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06182488
- Acronym / sponsor ID
- ERAS / 2023-YLS-010
- Conditions
- Acute Abdomen, Abdominal Trauma, Emergency Surgery
- Keywords
- Enhanced recovery after surgery (ERAS), Emergency surgery, Acute abdominal disease, Combined anesthesia, Goal-directed fluid therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Collaborators
- Tianjin Hospital
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A single center randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| ERAS Group | Experimental | Other: ERAS protocolsAccording to the ERAS guidelines, the ERAS group received ERAS protocol. |
| Conventional group | Other | Other: Conventional protocolsConventional perioperative interventions |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between the ages 18-70,
- Patients who completed the preoperative examination and preoperative diagnosis within 4 hours after admission for acute abdomen diseases,
- Required emergency surgery within 6 hours from surgeon encounter.
Key exclusion criteria (8 listed)
- Patients who refused to be enrolled in this study;
- Patients with any psychiatric or neurological disorders;
- Pseptic shock at admission;
- Duration of symptoms more than five days;
- Patients with contraindications to the placement of lumbar epidural catheters, such as coagulation disorders, severe sepsis, etc.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS protocolsERAS protocols for emergency abdominal surgery | Other | ERAS Group |
| Conventional protocolsConventional protocols for emergency abdominal surgery | Other | Conventional group |
Primary outcome
postoperative recovery time
Time frame: From enrollment to the end of treatment at 2 weeks
Postoperative recovery time that meets the relevant definitions in this study
5 secondary outcomes
the rate of postoperative complications
Time frame: From enrollment to the end of treatment at 2 weeks
The time of first postoperative flatus
Time frame: From enrollment to the end of treatment at 2 weeks
The time to tolerate semi-fluid diet after surgery
Time frame: From enrollment to the end of treatment at 2 weeks
The time to tolerate soft food after surgery
Time frame: From enrollment to the end of treatment at 2 weeks
The rate of readmission (in 30 days)
Time frame: From enrollment to the end of treatment at 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Zheng, MD contact
Hong Zheng, MD study chair
Tianjin First Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS protocols and Conventional protocols in people with Acute Abdomen and Abdominal Trauma, run by Tianjin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianing Lu, MD (86-022-60910136, lujianing2006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative recovery time (time frame: From enrollment to the end of treatment at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.