Peptic Ulcer PerforationERASENCT04194060
ERAS vs Conventional Approach in Peptic Perforation-RCT
A study testing Enhanced Recovery after Surgery group and Conventional in people with Peptic Ulcer Perforation and Perforated Bowel, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peptic Ulcer Perforation, Perforated Bowel, Post-Op Complication
- What is being tested?
- Enhanced Recovery after Surgery group and Conventional
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 20 Jan 2020to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Recovery After Surgery Versus Conventional Approach in Peptic Perforation-A Randomized Control Trial
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.
Read the detailed description
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
- Peptic Ulcer Perforation, Perforated Bowel, Post-Op Complication, Emergencies, Perioperative Complication
- Being tested
- Enhanced Recovery after Surgery group, Conventional
- Keywords
- ERAS, Emergency surgery, Fast track surgery, Perioperative Care, Enhanced recovery after surgery
- Medical subject headings
- Peptic Ulcer Perforation, Intestinal Perforation, Postoperative Complications, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery after Surgery groupCombination 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.
ConventionalCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced recovery after surgery group | Experimental | 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. Receives: Combination Product: Enhanced Recovery after Surgery group |
| Conventional group | Active comparator | 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 Receives: Combination Product: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Duration from the time of operation to time of discharge
Measured: Post operative period up-to one month.
Secondary outcomes (2)
Recovery of functional parameters
- 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)
Measured: Post operative period up-to one month.
Post operative complications
- 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
Measured: Post operative period up-to three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start20 Jan 2020
- Primary completion15 May 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peptic Ulcer PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient will be allocated into two arms, ERAS(Enhanced recovery after surgery) group and Conventional group. 30 patients will be recruited in each arm.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tushar Subhadarshan Mishra, All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- TUSHAR S MISHRA, MBBS,MS, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194060
- Sponsor's protocol ID
- AIIMS BBSR/PGT/2019-20/65
- Acronym
- ERASE
- Status last verified
- Mar 2022
- First submitted
- 22 Nov 2019
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28653239Lohsiriwat 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.
PubMed 30842811Agarwal 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.
PubMed 27509704Gonenc 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.
PubMed 24119887
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery Versus Conventional Approach in Peptic Perforation-A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04194060
- Acronym / sponsor ID
- ERASE / AIIMS BBSR/PGT/2019-20/65
- Conditions
- Peptic Ulcer Perforation, Perforated Bowel, Post-Op Complication, Emergencies, Perioperative Complication
- Keywords
- ERAS, Emergency surgery, Fast track surgery, Perioperative Care, Enhanced recovery after surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patient will be allocated into two arms, ERAS(Enhanced recovery after surgery) group and Conventional group. 30 patients will be recruited in each arm.
| Arm | Type | Receives |
|---|---|---|
| Enhanced recovery after surgery group | Experimental | Combination Product: Enhanced Recovery after Surgery groupERAS 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. |
| Conventional group | Active comparator | Combination Product: ConventionalCONVENTIONAL 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Refractory septic shock at presentation.
- Known Chronic kidney disease/ Chronic liver disease patients
- Pregnant patients.
- Patients with history of chronic steroid abuse.
- Intraoperatively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Enhanced recovery after surgery group |
| ConventionalTracheal 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. | Combination product | Conventional group |
Primary outcome
Length of hospital stay
Time frame: Post operative period up-to one month.
Duration from the time of operation to time of discharge
2 secondary outcomes
Recovery of functional parameters
Time frame: Post operative period up-to one month.
Post operative complications
Time frame: Post operative period up-to three months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Background: PubMed 28653239Mohsina 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.
- Background: PubMed 30842811Lohsiriwat 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.
- Background: PubMed 27509704Agarwal 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.
- Results publication: PubMed 24119887Gonenc 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TUSHAR S MISHRA, MBBS,MS principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery after Surgery group and Conventional in people with Peptic Ulcer Perforation and Perforated Bowel, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Post operative period up-to one month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04194060, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.