- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07650461
Enhanced Recovery Versus Standard Care After Emergency Abdominal Surgery in Patients Requiring Emergency Laparotomy
Comparison of Enhanced Recovery Protocol After Surgery Versus Conventional Care in Emergency Laparotomy
This study aims to compare an Enhanced Recovery After Surgery (ERAS) protocol with conventional postoperative care in adults undergoing emergency laparotomy for intestinal obstruction or intestinal perforation.
The main question this study aims to answer is:
• Does the ERAS protocol reduce surgical site infections compared with conventional care after emergency laparotomy?
Researchers will also compare other recovery outcomes between the two groups, including length of hospital stay, occurrence of paralytic ileus (temporary loss of bowel function), time to first bowel movement, and time to start taking fluids by mouth after surgery.
A total of 102 participants will be enrolled and randomly assigned to one of two groups. One group will receive postoperative care according to the ERAS protocol, while the other group will receive conventional postoperative care. All participants will undergo emergency laparotomy using standard surgical and anesthetic techniques.
Participants will:
- Undergo emergency laparotomy for intestinal obstruction or intestinal perforation.
- Receive either ERAS-based postoperative care or conventional postoperative care.
- Be monitored during their hospital stay for recovery and postoperative complications.
- Be assessed for bowel function recovery, ability to tolerate oral fluids, and length of hospital stay.
- Be followed for 30 days after surgery to determine whether a surgical site infection develops.
The researchers hypothesize that patients managed with the ERAS protocol will have a lower frequency of surgical site infections and improved postoperative recovery compared with those receiving conventional care.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
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Muzaffargarh, Punjab Province, Pakistan, 34200
- Recep Tayyip Erdogan Hospital Muzaffargarh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- acute intestinal obstruction or intestinal perforation
- planned for emergency laparotomy
Exclusion Criteria:
- Pregnant women
- Patients on chronic steroids
- Chronic obstructive pulmonary disease
- Malignant ulcers confirmed by histopathological examination
- laparoscopic surgeries
- Acute abdominal trauma
- Patients who require postoperative intensive care unit (ICU) care
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ERAS Protocol Group
Participants undergoing emergency laparotomy will receive postoperative care according to the Enhanced Recovery After Surgery (ERAS) protocol.
|
A standardized multimodal perioperative care pathway applied to patients undergoing emergency laparotomy.
The protocol includes pre-defined components for preoperative optimization, intraoperative management, and postoperative care.
Postoperative elements include early mobilization, early initiation of oral fluids and diet, optimized multimodal analgesia, early removal of tubes/drains when appropriate, and structured fluid management.
|
|
Active Comparator: Conventional Care Group
Participants undergoing emergency laparotomy will receive standard postoperative care as routinely practiced in the surgical unit.
|
Standard postoperative management routinely practiced in the surgical unit for patients undergoing emergency laparotomy.
Care includes traditional postoperative monitoring, routine analgesia, delayed initiation of oral intake, standard mobilization practices, and conventional fluid and supportive management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical Site Infection
Time Frame: From enrollment within 30 days postoperatively
|
Frequency of surgical site infection (superficial and deep) occurring within 30 days after emergency laparotomy will be assessed and compared between the Enhanced Recovery After Surgery (ERAS) group and the conventional care group.
Surgical site infection will be defined and classified according to standard surgical infection criteria as specified in the study protocol
|
From enrollment within 30 days postoperatively
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Stay
Time Frame: From surgery to discharge within 30 days
|
Length of hospital stay will be measured in days from the day of surgery until final disposition (discharge or death).
|
From surgery to discharge within 30 days
|
|
Paralytic Ileus
Time Frame: From surgery till hospital stay within 30 days postoperatively
|
Incidence of postoperative paralytic ileus defined as presence of abdominal distension with absence of bowel sounds on clinical examination (auscultation for at least one minute).
|
From surgery till hospital stay within 30 days postoperatively
|
|
Time to First Stool
Time Frame: From surgery till hospital stay until discharge within 30 days postoperatively
|
Time (in days) from surgery to passage of first postoperative stool, indicating return of bowel function.
|
From surgery till hospital stay until discharge within 30 days postoperatively
|
|
Time to First Fluid Diet
Time Frame: Postoperatively during hospital stay till discharge within 30 days postoperatively
|
Time (in days) from surgery to initiation and tolerance of first oral fluid intake postoperatively.
|
Postoperatively during hospital stay till discharge within 30 days postoperatively
|
Collaborators and Investigators
Investigators
- Study Chair: Muhammad I Seerat, FCPS, Recep Tayyip Erdogan Hospital Muzaffargarh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Intestinal Diseases
- Infections
- Digestive System Diseases
- Gastrointestinal Diseases
- Wound Infection
- Pathological Conditions, Signs and Symptoms
- Surgical Wound Infection
- Postoperative Complications
- Intestinal Obstruction
- Intestinal Perforation
- Surgical Procedures, Operative
- Perioperative Care
- Enhanced Recovery After Surgery
Other Study ID Numbers
- U1111-1342-1146
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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