Early Oral Feeding vs Traditional Post-operative Care In Emergency Abdominal Surgeries

NCT ID: NCT04431037

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-13
• Study Completion Date: 2019-12-27

Brief Summary

ABSTRACT BACKGROUND: Enhanced recovery after surgery (ERAS) protocols have been widely studied in elective abdominal surgeries and have shown better outcomes. However the utility of these protocols in emergency abdominal surgeries has not been widely investigated.

OBJECTIVE: To study the outcomes of application of ERAS protocols in patients undergoing perforated duodenal ulcers repairs in emergency abdominal surgeries.

METHODS: This randomized controlled trial was conducted in Surgical Unit 1 BBH from August 2018 to December 2019 with a total sample size of 36 patients with the diagnosis of perforated duodenal ulcer. Patients were randomly divided in two groups. Group A consisted of early oral feeding group and group B consisted of traditional postoperative care group. Outcome results studied were the length of hospital stay, duodenal repair site leak, severity of pain (VAS score) and duration of post-operative ileus. Results were analysed on SPSS version 20 and chi-square and independent t-test were applied.

KEY WORDS: Perforated duodenal ulcer, ERAS protocol, randomized controlled trial, duodenal repair site leak, length of hospital stay, VAS score, post-operative ileus

Conditions

Perforated Duodenal Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Early oral feeding group(A)

Patients admitted in the HDU postoperatively.NG tube and foley's catheter removed within 12 hours and patients allowed oral sips on day 1 with gradual shift to liquid diet after 12 hrs and semisolid food started after 24 hours later.Patients were given i/v antibiotics,painkillers and i/v PPIs and shifted to oral pain killers on 2nd POD.

Group Type: EXPERIMENTAL

Early oral feeding/Enhanced recovery after surgery protocols

Intervention Type: DIETARY_SUPPLEMENT

Early oral feeding refers to NG tube and foley's catheter removed within 12 hours and patients allowed oral sips on day 1 with gradual shift to liquid diet after 12 hrs and semisolid food started after 24 hours later.Patients were given i/v antibiotics,painkillers and i/v PPIs and shifted to oral pain killers on 2nd POD.

Traditional postoperative care group(B)

Patients in this group were managed traditionally

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early oral feeding/Enhanced recovery after surgery protocols

Early oral feeding refers to NG tube and foley's catheter removed within 12 hours and patients allowed oral sips on day 1 with gradual shift to liquid diet after 12 hrs and semisolid food started after 24 hours later.Patients were given i/v antibiotics,painkillers and i/v PPIs and shifted to oral pain killers on 2nd POD.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• All patients older than 15 years with acute abdominal symptoms admitted in ER department, suspected as perforated duodenal ulcer and operated within 24 hours of admission by emergency department surgeon.

Exclusion Criteria

• Patients presenting with the following criteria were excluded:
• Refusal to join the study
• Peptic ulcers with both bleeding and perforation.
• Spontaneously sealed off perforations.
• Malignant ulcers
• Concurrent extra-abdominal surgery
• Oral incapacity i.e endotracheal intubation
• Reoperation within a month
• ASA grade III/IV
• Alternative per operative diagnosis.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

College of Physicians and Surgeons Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Ayesha Masood

Postgraduate trainee, General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Surgical Unit I,Benazir Bhutto Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

pdu

Identifier Type: -

Identifier Source: org_study_id