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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced recovery after surgery group | Experimental | ERAS GROUP
|
|
| Conventional group | Active Comparator | CONVENTIONAL GROUP
I |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Recovery after Surgery group | Combination Product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Duration from the time of operation to time of discharge | Post operative period up-to one month. |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of functional parameters |
| Post operative period up-to one month. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life scoring and assessment | 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. |
Inclusion Criteria:
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 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.
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| Name | Affiliation | Role |
|---|---|---|
| TUSHAR S MISHRA, MBBS,MS | All India Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tushar S Mishra | Bhubaneswar | Odisha | 751019 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28653239 | Background | Mohsina S, Shanmugam D, Sureshkumar S, Kundra P, Mahalakshmy T, Kate V. Adapted ERAS Pathway vs. Standard Care in Patients with Perforated Duodenal Ulcer-a Randomized Controlled Trial. J Gastrointest Surg. 2018 Jan;22(1):107-116. doi: 10.1007/s11605-017-3474-2. Epub 2017 Jun 26. | |
| 30842811 | Background | Lohsiriwat V, Jitmungngan R. Enhanced recovery after surgery in emergency colorectal surgery: Review of literature and current practices. World J Gastrointest Surg. 2019 Feb 27;11(2):41-52. doi: 10.4240/wjgs.v11.i2.41. |
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| ID | Term |
|---|---|
| D010439 | Peptic Ulcer Perforation |
| D007416 | Intestinal Perforation |
| D011183 | Postoperative Complications |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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Patient will be allocated into two arms, ERAS(Enhanced recovery after surgery) group and Conventional group. 30 patients will be recruited in each arm.
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|
| Conventional | Combination Product | Tracheal intubation
|
|
| Post operative complications |
| Post operative period up-to three months. |
| Post operative period - at day of discharge, at one month follow up and at third month follow up. |
| Intra-abdominal collection | 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. | Post operative period-at one month and at third month in post operative period. |
| Hematological parameter | 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. | Post-operative period up-at one month and at third month. |
| 27509704 | Background | Agarwal A, Jain S, Meena LN, Jain SA, Agarwal L. Validation of Boey's score in predicting morbidity and mortality in peptic perforation peritonitis in Northwestern India. Trop Gastroenterol. 2015 Oct-Dec;36(4):256-60. doi: 10.7869/tg.300. |
| 24119887 | Result | Gonenc M, Dural AC, Celik F, Akarsu C, Kocatas A, Kalayci MU, Dogan Y, Alis H. Enhanced postoperative recovery pathways in emergency surgery: a randomised controlled clinical trial. Am J Surg. 2014 Jun;207(6):807-14. doi: 10.1016/j.amjsurg.2013.07.025. Epub 2013 Oct 10. |
| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |