Enhanced Recovery After Surgery (ERAS) Protocols on Postoperative Outcomes in Patients Undergoing Major Abdominal Procedures

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDr Mudassar Saeed Pansota

About this trial

ERAS protocols are still only partially and unevenly implemented in many hospitals in developing nations, despite substantial worldwide evidence to the contrary. Because of institutional regulations, lack of understanding, or budget constraints, local surgical units frequently stick to traditional perioperative care approaches. Furthermore, there is a dearth of local data assessing the viability and efficacy of ERAS protocols in patients undergoing significant abdominal surgeries in our healthcare settings. Thus, the purpose of this study is to evaluate how ERAS protocols affect the postoperative results of patients having major abdominal surgery at our facility. The study's findings will be useful in determining whether ERAS pathways will assist our patient population heal more quickly, experience fewer issues, and spend less time in the hospital. The results might potentially encourage the use of standardized ERAS procedures in surgical practice, which would enhance patient care and maximize the use of medical resources

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients of either gender between the ages of 18 and 70 years.

Individuals having elective major abdominal surgery (such as small bowel resection, right hemicolectomy, left hemicolectomy, sigmoid colectomy, anterior resection, or similar colorectal resection).

ASA class I-III patients

Disqualifiers

Patients who need to stay in the intensive care unit (ICU) after surgery for more than twenty-four hours.

Individuals suffering from significant organ malfunction, such as advanced heart, liver, or kidney failure.

Individuals who have had significant abdominal surgery within the recent three months.

Patients who withdraw their consent or decline to participate in the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • ERAS

    Procedure/Surgery

    Patients managed by the surgical team according to the ERAS pathway will be included in Group A (ERAS group)

  • Standard Care (in control arm)

    Procedure/Surgery

    Patients managed according to routine conventional perioperative care during the study period will be included in Group B (conventional care group)

Treatment groups

166 Participants
are divided into 2 treatment groups
Group A: ERASExperimental treatment 1 intervention
Group B: Standard carePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of Postoperative Complications

Surgical site infection: superficial, deep, or organ-space infection diagnosed clinically by the treating surgeon or supported by wound findings, culture results, imaging, or the need for antibiotics or drainage. Anastomotic leak: clinical or radiological evidence of leakage from a surgical anastomosis, including feculent discharge from drain or wound, intra-abdominal collection related to anastomosis, or leak confirmed on imaging or reoperation. Ileus: failure of return of bowel function requiring continued nil per oral status, nasogastric decompression, or delayed oral intake beyond routine postoperative recovery as documented by the surgical team). As recorded in the patient's medical file, complications will be found by radiological results, laboratory tests, and clinical examinations

Time frame
30 days
2

Mean hospital stay

described as the total number of days between the day of surgery and the day of hospital discharge. For every patient, it will be computed in days and documented

Time frame
1 week

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr Mudassar Saeed Pansota

Lead sponsor

Shahida Islam Medical Complex

Sponsor institution

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