Enhanced Recovery Versus Standard Care After Emergency Abdominal Surgery in Patients Requiring Emergency Laparotomy

NCT07650461 | Completed

• 1 other identifier: U1111-1342-1146
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emergency Laparotomy; Intestinal Obstruction; Intestinal Perforation; Enhanced Recovery After Surgery (ERAS) Protocol; Surgical Site Infection (SSI); Postoperative Recovery

Keywords

Enhanced Recovery After Surgery; Emergency Laparotomy; Surgical Site Infection; Postoperative complications; Intestinal Obstruction; Intestinal Perforation; Length of Hospital Stay; Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection

  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 Outcomes (4)

• Hospital Stay

  From surgery to discharge within 30 days

• Paralytic Ileus

  From surgery till hospital stay within 30 days postoperatively

• Time to First Stool

  From surgery till hospital stay until discharge within 30 days postoperatively

Study Arms (2)

ERAS Protocol Group

EXPERIMENTAL

Participants undergoing emergency laparotomy will receive postoperative care according to the Enhanced Recovery After Surgery (ERAS) protocol.

Procedure: Enhanced Recovery After Surgery

Conventional Care Group

ACTIVE COMPARATOR

Participants undergoing emergency laparotomy will receive standard postoperative care as routinely practiced in the surgical unit.

Procedure: Conventional Postoperative Care

Interventions

Enhanced Recovery After Surgery PROCEDURE

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.

ERAS Protocol Group

Conventional Postoperative Care PROCEDURE

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.

Conventional Care Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute intestinal obstruction or intestinal perforation
• planned for emergency laparotomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Recep Tayyip Erdogan Hospital Pakistan - Muzaffargarh: lead

Study Sites (1)

Recep Tayyip Erdogan Hospital Muzaffargarh

Muzaffargarh, Punjab Province, 34200, Pakistan

Location

MeSH Terms

Conditions

Intestinal Obstruction; Intestinal Perforation; Surgical Wound Infection; Postoperative Complications

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Wound Infection; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Officials

• Muhammad I Seerat, FCPS

  Recep tayyip Erdogan Hospital Muzaffargarh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: May 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)