Comparison of routine care Vs assisted recovery based care in patients undergoing surgical closure of intestinal opening on the abdominal wall.

Not yet recruiting

• Conditions: Disease of intestine, unspecified,

• Registration Number: CTRI/2020/08/027349
• Lead Sponsor: JIPMER

Brief Summary

Bowel surgeries, particularly needing intestinal anastomosis have conventionally been managed by prolonged abstinence from oral intake, usage of opioid analgesics, insertion of nasogastric tube and urinary catheter etc. ERAS protocol is a streamlined multimodal approach which utilizes various evidence-based modifications of the perioperative care elements with the aim of attenuating the physiological and psychological stress, thus accelerating patients’ recovery. Though ERAS protocol based management has yielded significant success in colorectal surgeries, not many studies have been conducted to compare ERAS protocol vs standard care in elective stoma closure surgeries.

The study expects ERAS pathway management to be superior to conventional care for elective stoma reversal surgeries. Patient managed by ERAS pathway is expected to have shorter length of hospitalization (LOH), low morbidity/mortality/readmission rates which in turn will result in wider implementation of the protocol and lower burden on the healthcare system.If the ERAS protocol is found to be safe and feasible with shorter LOH, it may be uniformly implemented in all elective stoma closure surgeries.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-08-14
• Study Start: 2020-10-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• all eligible subjects between the age of 18 yrs.
• 60 yrs will be included in the study.

Exclusion Criteria

• Age<18 years.
• ASA class 3 or 4.
• Patients requiring/planned for laparotomy for stoma reversal.
• Patients with neurological and/or renal disorders, cardiac illnesses, bed ridden patients and patients on steroids.
• Patients unable to understand/respond to verbal or written commands.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the length of hospitalization (LOH) in patients managed with ERAS protocol with that of patients managed by standard protocols in elective stoma reversal surgeries	7 days LOH in control arm vs 5 days LOH in ERAS (study) arm

Secondary Outcome Measures

Name	Time	Method
duration of ileus and time to first bowel sound	6 hrs in ERAS (study) arm vs more than 6 hrs in Control arm
time to first fluid diet and first solid diet	oral sips by 6 hrs and escalation to clear liquids by 12 hrs and liquid diet by 24 hrs in ERAS (study arm)

Trial Locations

Locations (1)

JAWAHARLAL INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH (JIPMER); 🇮🇳 Pondicherry, PONDICHERRY, India

JAWAHARLAL INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH (JIPMER)

🇮🇳Pondicherry, PONDICHERRY, India

MADAN S

Principal investigator

7204132686

madanshivakumar@gmail.com