Emergencies Clinical Trial
— TUBELESSOfficial title:
Impact of Abdominal Drains on the Efficacy of ERAS Pathway in the Perioperative Management of Peptic Perforation - A Randomized Control Trail (TUBELESS TRAIL)
This study plans to assess the effect of placement of abdominal drains on the outcomes of ERAS (Enhanced recovery after surgery) protocol in the perioperative management of peptic perforation. In the study arm ERAS protocol will be implemented avoiding use of abdominal drain. In the control arm abdominal drains will be placed in the early post operative period while using the ERAS protocol. The effect of drains on duration of post operative stay and other return to physiological parameter like onset of ambulation, oral intake, passing flatus and feces etc. will be studied. The investigators hypothesize that the non-placement of abdominal drain postoperatively will not have worse outcomes than in cases where it is used postoperatively, in terms of length of hospital stay. .
Status | Recruiting |
Enrollment | 92 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient of peptic ulcer perforation peritonitis ( when confirmed intraoperatively) - Perforation of size less than or equal to 1 cm. - Patient age more than 18 years age - American society of anesthesiologists score of I or II Exclusion Criteria: - Refractory septic shock at presentation - Known Chronic kidney disease (CKD)/Chronic liver disease (CLD) patients - Deranged LFT, RFT or active respiratory illness pneumonia or COPD ( Spo2 below 94 on room air) - Pregnant patients - History of chronic steroid abuse - INTRAOPERATIVELY detected coexistent bleeding peptic ulcer, perforation requiring operation other than omental patch repair, spontaneously sealed peptic perforation, malignant perforation - Patient requiring positive pressure ventilatory support post-operatively for more than 6 hours. - Patient refusing consent. - Co-existent neurological or psychiatric illness or unable to understand the study |
Country | Name | City | State |
---|---|---|---|
India | All India Institute of Medical Sciences, | Bhubaneswar | Odisha |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, Bhubaneswar |
India,
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. — View Citation
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. Ep — View Citation
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. — View Citation
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/s11605-017-3 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of hospital stay (in days) | Duration from the time of operation to time of discharge | Post operative period up-to one month. | |
Secondary | Early postoperative abdominal pain measured using the Verbal numeric scale (VNS) | Verbal numeric scale (VNS) measured in the early postoperative period at different time frames as mentioned. Verbal numeric scale score will include score from 0 to10.On asking patient will grade his /her severity of pain between 0 to 10. 0 means the no pain and 10 means worst imaginable pain. | At 8 hours, 24 hours and 72 hours postoperatively | |
Secondary | Time of recovery of Functional parameters (in hours) | Onset of walk, onset of flatus, onset of stool, onset of liquid diet, onset of solid diet, onset of complete oral diet (discontinuation of IV fluids) | Up to one month post operatively | |
Secondary | Incidence of Complications | Skin and soft tissue infection (SSI), Intra-abdominal Abscess, Abdominal wound dehiscence, Duodeno / gastro-cutaneous fistula, Post operative pneumonia, post operative paralytic ileus beyond 72 hours | Up-to one month post operatively | |
Secondary | Need for re-intervention in either arm | Number times an intervention is required for delay in recovery of functional parameters or an early complication e.g. reinsertion of Ryle's tube, Ultrasonography (USG) guided aspiration or drainage, or open drainage or re operation will be recorded | Up-to one month post operatively | |
Secondary | Re-admission rates | Readmission for any post operative complications like fever/ or delayed functional recovery or any intervention will be recorded | Date of discharge to 1 month post operative period | |
Secondary | 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,0 slight problems, moderate problems, severe problems and extreme problems. Objective component is also called Euroqol visual analog scale. Score ranges from zero (the worst possible health status the participant can imagine) to 100 (the best possible health outcome the 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. | Post operative period - at 48 hours after surgery, at one month follow up and at third month follow up. | |
Secondary | Degree of compliance to the ERAS protocol | The degree of compliance to each of the parameters in the ERAS protocol will be recorded and expressed in percentage | Up to the time of discharge |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05552989 -
Towards Better Preparedness for Future Catastrophes - Local Lessons-learned From COVID-19
|
||
Not yet recruiting |
NCT04915690 -
Investigation on the Practice Status of Emergency Stuff
|
||
Not yet recruiting |
NCT03424096 -
Primary Palliative Care Education, Training, and Technical Support for Emergency Medicine
|
N/A | |
Completed |
NCT02534324 -
The Effect of Pre-discharge Blood Pressure of Patients With Asymptomatic Severe Hypertension in Emergency Department
|
N/A | |
Completed |
NCT00991471 -
The Effect of an Physician-Nurse Supplementary Triage Assistance Team on Emergency Department Patient Wait Times
|
N/A | |
Recruiting |
NCT03257319 -
Inhaled vs IV Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department
|
Phase 3 | |
Recruiting |
NCT05005117 -
Laparoscopic Approach for Emergency Colon Resection
|
N/A | |
Recruiting |
NCT03917368 -
Ultrasound Evaluation of the Jugular Venous Pulse (US-JVP)
|
N/A | |
Completed |
NCT04601922 -
Qualitative Study of Long Term Cardiovascular Risk Prediction in the Emergency Department
|
||
Recruiting |
NCT05497830 -
Machine Learning for Risk Stratification in the Emergency Department (MARS-ED)
|
N/A | |
Active, not recruiting |
NCT06220916 -
The Greek Acute Dance Injuries Registry
|
||
Recruiting |
NCT05543772 -
Evaluation of Blood Sampling From a Pre-existed Peripheral Intravenous Catheter Line
|
Phase 4 | |
Recruiting |
NCT06072534 -
Evaluation of Effectiveness of Two Different Doses of Mivacurium in Rapid Sequence Intubation
|
N/A | |
Recruiting |
NCT05496114 -
Medical Checklists in the Emergency Department
|
N/A | |
Not yet recruiting |
NCT05528211 -
Safety and Efficacy of Emergent TAVI in Patients With Severe AS
|
||
Completed |
NCT05818215 -
Impact of the Qatar 2022 FIFA World Cup on PED Use and Misuse Patterns
|
||
Recruiting |
NCT04615065 -
Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
|
||
Active, not recruiting |
NCT04648449 -
Artificial Intelligence (AI) Support in Medical Emergency Calls
|
||
Active, not recruiting |
NCT05221697 -
Effect of an ML Electronic Alert Management System to Reduce the Use of ED Visits and Hospitalizations
|
N/A | |
Not yet recruiting |
NCT04431986 -
ER2 Frailty Levels and Incident Adverse Health Events in Older Community Dwellers
|