Perforated Peptic UlcerTUBELESSNCT05368233
Impact of Abdominal Drains on the ERAS Pathway in Peptic Perforation
A study testing ERAS protocol in people with Perforated Peptic Ulcer and Fast Track Surgery, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perforated Peptic Ulcer, Fast Track Surgery, Perforated Bowel
- What is being tested?
- ERAS protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jun 2022to Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences,
Bhubaneswar, Odisha, 751020
TUSHAR S MISHRA, MBBS,MS,FACS, +91 9438884251, surg_tushar@aiimsbhubaneswar.edu.in
ANKIT RANA, MBBS, +91 7018212942, ankitrana124@gmail.com
About this study
Official 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.
.
Read the detailed description
ERAS is a an evidence based perioperative care pathways aiming reduction in the surgical stress. ERAS is a an evidence based perioperative care pathways aiming reduction in the surgical stress. Studies assessing the outcome of non usage to abdominal drains on the post-operative outcomes are scarce. This study aims to study the influence of abdominal drains on the post operative hospital stay and other functional outcomes.
Methods Patient with hollow viscus perforation to the emergency rooms and diagnosed to have peptic ulcer perforation intraoperatively will be included in the study. After omental patch repair and completion of operative procedure, patient will be randomized into drain group and no drain group based on the random allocation software.
Preoperative Early identification of physiological derangement and intervention. Early identification of physiological derangement and intervention. Early identification of physiological derangement and intervention. Early imaging , surgery and source control of sepsis. Risk assessment - PULP (Peptic Ulcers Perforation) score, Mannheim peritonitis index score, Boey score.
Intraoperatively Short acting anesthesia agents. warm normal saline lavage. Omental patch repair. Bilateral rectus sheath block. Bilateral rectus sheath block. Peritoneal fluid for culture and sensitivity. Mucosal edge / pinch biopsy to rule out any malignancy. Post operative nausea and vomiting (PONV) prophylaxis Balanced intravenous fluid administration. Post operatively Immobilization, Oral intake, Intravenous nutrition after study, Removal of nasogastric tube, Removal of catheter.
Intervention Abdominal drain group with ERAS protocol and no abdominal drain group with ERAS protocol.
Sample size calculation Sample size is calculated using "R". A sample size of 76 (38 per group) was calculated with the study powered at 90 percent, to prove that the no abdominal drain group is non inferior compared to the abdominal drain group in terms of length of hospital stay. The clinically relevant non inferiority margin was assumed is one day. The alpha error assumed 0.05 ( mention about loss to follow up. The pooled Standard deviation (SD) taken from previous study (done at our institute by Mishra TS et al) 1.5. Assuming a loss to follow up of 15 percent. The ultimate sample size was calculated to be 76+11=87. 87 cases will be taken on the whole to ensure equal distribution in both arms. Recruitment will be stopped at 76 cases along with necessary follow up or at 87 including loss to follow up which ever is achieved earlier.
- Conditions
- Perforated Peptic Ulcer, Fast Track Surgery, Perforated Bowel, Post-Op Complication, Emergencies
- Being tested
- ERAS protocol
- 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.
ERAS protocolOther
Also called Fast track study
ERAS protocol whch helps to optimise the length of hospital stay.
| Study group | Role | What they receive |
|---|---|---|
| ERAS protocol without the use of of abdominal drain in the perforated peptic ulcer patient | Experimental | Tracheal intubation. Short acting anesthetic agents,avoid opioid agents . Omental patch repair without placement of sub hepatic drain. Bilateral Transverse abdominis plane block/ Rectus sheath block immediately after surgery.
Abdominal drain will not be placed 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.
Avoid opioid analgesics. Receives: Other: ERAS protocol |
| ERAS protocol with the use of of abdominal drain in the perforated peptic ulcer patient | Active comparator | 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.
Abdominal Drains will be placed and removed at anytime within 24 hrs and to not remove if the output is bilious or pus.
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.
Placing Sub hepatic drain intraoperatively. Avoid opioid analgesics. Receives: Other: ERAS protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay (in days)
Duration from the time of operation to time of discharge
Measured: Post operative period up-to one month.
Secondary outcomes (7)
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.
Measured: At 8 hours, 24 hours and 72 hours postoperatively
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)
Measured: Up to one month post operatively
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
Measured: Up-to one month post operatively
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
Measured: Up-to one month post operatively
Re-admission rates
Readmission for any post operative complications like fever/ or delayed functional recovery or any intervention will be recorded
Measured: Date of discharge to 1 month post operative period
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.
Measured: Post operative period - at 48 hours after surgery, at one month follow up and at third month follow up.
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
Measured: Up to the time of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start15 Jun 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
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 Perforated Peptic UlcerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
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,FACS, Principal investigator, All India Institute of Medical Sciences, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368233
- Sponsor's protocol ID
- PG Thesis/2021-22/111
- Acronym
- TUBELESS
- Status last verified
- Feb 2023
- First submitted
- 8 Apr 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24119887Mohsina 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 27509704
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Abdominal Drains on the Efficacy of ERAS Pathway in the Perioperative Management of Peptic Perforation - A Randomized Control Trail (TUBELESS TRAIL)
- ClinicalTrials.gov ID
- NCT05368233
- Acronym / sponsor ID
- TUBELESS / PG Thesis/2021-22/111
- Conditions
- Perforated Peptic Ulcer, Fast Track Surgery, Perforated Bowel, Post-Op Complication, Emergencies
- Keywords
- ERAS, Emergency surgery, fast track surgery, perioperative care, Enhanced recovery after surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 May 2022 (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 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.
.
Detailed description
ERAS is a an evidence based perioperative care pathways aiming reduction in the surgical stress. ERAS is a an evidence based perioperative care pathways aiming reduction in the surgical stress. Studies assessing the outcome of non usage to abdominal drains on the post-operative outcomes are scarce. This study aims to study the influence of abdominal drains on the post operative hospital stay and other functional outcomes.
Methods Patient with hollow viscus perforation to the emergency rooms and diagnosed to have peptic ulcer perforation intraoperatively will be included in the study. After omental patch repair and completion of operative procedure, patient will be randomized into drain group and no drain group based on the random allocation software.
Preoperative Early identification of physiological derangement and intervention. Early identification of physiological derangement and intervention. Early identification of physiological derangement and intervention. Early imaging , surgery and source control of sepsis. Risk assessment - PULP (Peptic Ulcers Perforation) score, Mannheim peritonitis index score, Boey score.
Intraoperatively Short acting anesthesia agents. warm normal saline lavage. Omental patch repair. Bilateral rectus sheath block. Bilateral rectus sheath block. Peritoneal fluid for culture and sensitivity. Mucosal edge / pinch biopsy to rule out any malignancy. Post operative nausea and vomiting (PONV) prophylaxis Balanced intravenous fluid administration. Post operatively Immobilization, Oral intake, Intravenous nutrition after study, Removal of nasogastric tube, Removal of catheter.
Intervention Abdominal drain group with ERAS protocol and no abdominal drain group with ERAS protocol.
Sample size calculation Sample size is calculated using "R". A sample size of 76 (38 per group) was calculated with the study powered at 90 percent, to prove that the no abdominal drain group is non inferior compared to the abdominal drain group in terms of length of hospital stay. The clinically relevant non inferiority margin was assumed is one day. The alpha error assumed 0.05 ( mention about loss to follow up. The pooled Standard deviation (SD) taken from previous study (done at our institute by Mishra TS et al) 1.5. Assuming a loss to follow up of 15 percent. The ultimate sample size was calculated to be 76+11=87. 87 cases will be taken on the whole to ensure equal distribution in both arms. Recruitment will be stopped at 76 cases along with necessary follow up or at 87 including loss to follow up which ever is achieved earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS protocol without the use of of abdominal drain in the perforated peptic ulcer patient | Experimental | Other: ERAS protocolTracheal intubation. Short acting anesthetic agents,avoid opioid agents . Omental patch repair without placement of sub hepatic drain. Bilateral Transverse abdominis plane block/ Rectus sheath block immediately after surgery. Abdominal drain will not be placed 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. Avoid opioid analgesics. |
| ERAS protocol with the use of of abdominal drain in the perforated peptic ulcer patient | Active comparator | Other: ERAS protocolTracheal 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. Abdominal Drains will be placed and removed at anytime within 24 hrs and to not remove if the output is bilious or pus. 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. Placing Sub hepatic drain intraoperatively. Avoid opioid analgesics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| ERAS protocolAlso: Fast track studyERAS protocol whch helps to optimise the length of hospital stay. | Other | ERAS protocol with the use of of abdominal drain in the perforated peptic ulcer patient, ERAS protocol without the use of of abdominal drain in the perforated peptic ulcer patient |
Primary outcome
Length of hospital stay (in days)
Time frame: Post operative period up-to one month.
Duration from the time of operation to time of discharge
7 secondary outcomes
Early postoperative abdominal pain measured using the Verbal numeric scale (VNS)
Time frame: At 8 hours, 24 hours and 72 hours postoperatively
Time of recovery of Functional parameters (in hours)
Time frame: Up to one month post operatively
Incidence of Complications
Time frame: Up-to one month post operatively
Need for re-intervention in either arm
Time frame: Up-to one month post operatively
Re-admission rates
Time frame: Date of discharge to 1 month post operative period
Quality of life scoring and assessment
Time frame: Post operative period - at 48 hours after surgery, at one month follow up and at third month follow up.
Degree of compliance to the ERAS protocol
Time frame: Up to the time of discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- 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,FACS principal investigator
All India Institute of Medical Sciences, Bhubaneswar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS protocol in people with Perforated Peptic Ulcer and Fast Track Surgery, 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 9 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: status not confirmed, as of the sponsor's last update on 6 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TUSHAR S MISHRA, MBBS,MS,FACS (+91 9438884251, surg_tushar@aiimsbhubaneswar.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (in days) (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 NCT05368233, 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 6 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.