Impact of Abdominal Drains on the ERAS Pathway in Peptic Perforation (NCT05368233) | Clinical Trial Compass
UnknownNot Applicable
Impact of Abdominal Drains on the ERAS Pathway in Peptic Perforation
India92 participantsStarted 2022-06-15
Plain-language summary
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.
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Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Length of hospital stay (in days)
Timeframe: Post operative period up-to one month.
Trial details
NCT IDNCT05368233
SponsorAll India Institute of Medical Sciences, Bhubaneswar