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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

zhenghongyx@139.com

China1 site, 1 recruiting
  • Tianjin Hospital

    Tianjin, Tianjin Municipality, 300000

    Bin Dai, +86 138 2166 0137, 490621209@qq.com

    Yan Zhuang, MD

    Recruiting

Other trials in China

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.
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 groups in NCT06182488
Study groupRoleWhat they receive
ERAS GroupExperimentalAccording to the ERAS guidelines, the ERAS group received ERAS protocol.
Receives: Other: ERAS protocols
Conventional groupOtherConventional perioperative interventions
Receives: Other: Conventional protocols

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. The time of first postoperative flatus

    The time of first postoperative flatus

    Measured: From enrollment to the end of treatment at 2 weeks

  3. 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

  4. 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

  5. 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.

  1. First posted27 Dec 2023
  2. Study start1 Nov 2023
  3. Primary completion30 Nov 2023
  4. Study completion30 May 2024 (estimated)

Resources

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)
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

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.

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