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Completed

NCT Number: NCT04194060

ERAS vs Conventional Approach in Peptic Perforation-RCT

This study compares 2 different ways of perioperative management in patients of peptic perforation. Experimental arm is the ERAS arm( Enhanced recovery after surgery) and the comparative arm is Conventional arm.

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Key information

Conditions

Peptic Ulcer Perforation Digestive System Diseases Disease Attributes Duodenal Diseases Emergencies Gastrointestinal Diseases Intestinal Diseases Intestinal Perforation Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Perforated Bowel Perioperative Complication Post-Op Complication Postoperative Complications Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tushar S Mishra

Bhubaneswar, Odisha, 751019, India

About this study

While the conventional approach to perioperative management can potentially prolong the post operative hospital stay, ERAS(Enhanced recovery after surgery), a multi-modal and multispeciality approach to perioperative management may reduce the length of hospital stay. In the preoperative period, patients will be counselled regarding the operative procedure and particulars of the perioperative management.In the intra-operative period short acting general anesthetic agents and short acting muscle relaxants will be used.Intravenous fluid administration will be goal directed. After the operative procedure, bilateral rectus sheath block will be administered. Patient will also receive post-operative nausea and vomiting prophylaxis. Nasogastric tube will be removed immediately after the operative procedure. In the post operative period, patients will be encouraged to ambulate early. Enteral nutrition will be initiated as early as possible. Indwelling catheters will be removed in the early post-operative procedure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient diagnosed with peptic perforation intra -operatively
  • Perforation of size <=1 cm
  • Patient age more than 18 years
  • American Society of Anesthesiologists score of I or II

Exclusion criteria

  • Refractory septic shock at presentation.
  • Known Chronic kidney disease/ Chronic liver disease patients
  • Pregnant patients.
  • Patients with history of chronic steroid abuse.
  • Intraoperatively
  • Patient with coexistent peptic perforation with bleeding ulcer.
  • Peptic perforation requiring procedure other than Omental patch repair.
  • Sealed perforations.
  • Malignant perforation.
  • Patient requiring Positive Pressure Ventilator support post operatively for more than 12 hours.
  • Patient requiring urinary catheterization for other indications.
  • Coexistent neurological or psychiatric illness or unable to understand the study.
  • Patient refusing for consent.

Treatment and study plan

Enhanced Recovery after Surgery group

Combination Product
  • Tracheal intubation and with General anesthesia
  • Short acting anesthetic agents,avoid opioid agents
  • Omental patch repair with placement of sub hepatic drain
  • Bilateral Transverse abdominis plane block/ Rectus sheath block immediately after surgery.
  • Post operative nausea and vomiting prophylaxis.
  • Encourage to mobilize out of bed after effect of general anesthesia has weaned off.
  • Initiation of feeding-Oral sips on day 1, step up day 2 onward
  • Removal of nasogastric tube-immediately after surgery after aspirating the gastric content through nasogastric tube.
  • Removal of urinary catheter-after weaning from the effect of general anesthesia.
  • Sub hepatic drain removal -anytime within 24 hours;drain will not be removed if fluid is bilious or pus.
  • Avoid opiod analgesics.

Conventional

Combination Product

Tracheal intubation

  • Short acting anesthetic agents, avoid opiod anesthesia agents.
  • Omental patch repair along with sub hepatic drain placement.
  • Post operative nausea and vomiting prophylaxis.
  • Ambulation-as per patients' own request.
  • Initiation of oral feed- after passage of 1st flatus.
  • Nasogastric tube removal-output <300ml/day with resolution of ileus.
  • Removal of urinary catheter- when patient sits on bed side/ambulate.
  • Removal of sub hepatic drain-when patient tolerates unrestricted amount of liquid diet and drain output is less than 200 ml /day.
  • Patient will receive opiod analgesics.

Primary outcomes

  1. Length of hospital stay

    Time frame: Post operative period up-to one month.

    Duration from the time of operation to time of discharge

Secondary outcomes

  1. Recovery of functional parameters

    Time frame: Post operative period up-to one month.

    • Time of withdrawal of nasogastric tube (hours)
    • Time to first bowel sound (hours)
    • Time to first flatus (hours)
    • Time to first stool (hours)
    • Time to removal of drain(hours)
    • Time to first fluid diet (hours)
    • Time to first solid diet (hours)
    • Time to stoppage of IV fluids(hours)
    • Time of removal of urinary catheter (hours)
    • Time to ambulation(hours)

  2. Post operative complications

    Time frame: Post operative period up-to three months.

    • Anastomotic leakage
    • Pneumonia
    • Ileus
    • Obstruction
    • Wound infection
    • Abdominal sepsis
    • Burst Abdomen
    • Need for reinsertion of nasogastric tube
    • Need for reinsertion of urinary catheter
    • Need for drainage of abdominal collection
    • Readmission
    • Re operation
    • Mortality

Other outcomes

  1. Quality of life scoring and assessment

    Time frame: Post operative period - at day of discharge, at one month follow up and at third month follow up.

    Quality of life assessment will be done using EQ-5D-5L questionnaire (Euroqol 5 dimensions and 5 levels). It has 2 components, descriptive and objective. Descriptive component comprises of 5 dimensions which are mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels, namely no problem, slight problems, moderate problems, severe problems and extreme problems. Objective component is also called Euroqol visual analog scale. Score ranges from zero to hundred.The endpoints are labelled as 'the best health participant can imagine' and 'the worst health participant can imagine'. It will be assessed on the day of discharge, follow up at one month and follow up at third month in the post operative period.

  2. Intra-abdominal collection

    Time frame: Post operative period-at one month and at third month in post operative period.

    Ultrasonography abdomen will be done at one month to look for any intra-abdominal collection and if any collection is found, will be repeated at third month follow up.

  3. Hematological parameter

    Time frame: Post-operative period up-at one month and at third month.

    Total leukocyte count will be measured at follow up at one month.If the value is more than 11,000 cells/mm cube or less than 4000 cells/mm cube, then it will be measured again at third month of follow up.

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Official study title

Enhanced Recovery After Surgery Versus Conventional Approach in Peptic Perforation-A Randomized Control Trial

Acronym: ERASE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2019
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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