ERAS vs Conventional Approach in Peptic Perforation-RCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2021-06-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Peptic Ulcer Perforation Perforated Bowel Post-Op Complication Emergencies Perioperative Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patient will be allocated into two arms, ERAS(Enhanced recovery after surgery) group and Conventional group. 30 patients will be recruited in each arm.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Enhanced recovery after surgery group

ERAS GROUP

* Tracheal intubation.
* 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.

Group Type EXPERIMENTAL

Enhanced Recovery after Surgery group

Intervention Type 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 group

CONVENTIONAL GROUP

* 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.

I

Group Type ACTIVE_COMPARATOR

Conventional

Intervention Type 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.

Interventions

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Enhanced Recovery after Surgery group

* 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.

Intervention Type COMBINATION_PRODUCT

Conventional

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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Refractory septic shock at presentation.
2. Known Chronic kidney disease/ Chronic liver disease patients
3. Pregnant patients.
4. Patients with history of chronic steroid abuse.
5. Intraoperatively

* Patient with coexistent peptic perforation with bleeding ulcer.
* Peptic perforation requiring procedure other than Omental patch repair.
* Sealed perforations.
* Malignant perforation.
6. Patient requiring Positive Pressure Ventilator support post operatively for more than 12 hours.
7. Patient requiring urinary catheterization for other indications.
8. Coexistent neurological or psychiatric illness or unable to understand the study.
9. Patient refusing for consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes