An interventional study of ERAS protocol in Perforated Peptic Ulcer, Fast Track Surgery and Perforated Bowel, sponsored by All India Institute of Medical Sciences, Bhubaneswar. Status unknown at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by All India Institute of Medical Sciences, Bhubaneswar · Not applicable, Interventional, and Treatment
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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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.
21 studies on the registry are indexed under Peptic Ulcer Perforation; 4 are open to participants now.
This study's planned enrollment of 92 is above the median of 66 across 16 interventional studies indexed under Peptic Ulcer Perforation.
Browse Peptic Ulcer Perforation studies →All India Institute of Medical Sciences, Bhubaneswar is the lead sponsor of 59 studies on the registry; 25 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: ERAS protocol
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.
Other: ERAS protocol
ERAS protocol whch helps to optimise the length of hospital stay.
Also known as: Fast track study
Length of hospital stay (in days)
Duration from the time of operation to time of discharge
Time frame: Post operative period up-to one month.
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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
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
The degree of compliance to each of the parameters in the ERAS protocol will be recorded and expressed in percentage
Time frame: Up to the time of discharge
Plan to share: No
Started Jun 2022 (actual). Primary completion is estimated for Dec 2023, 18 months after the start.
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All India Institute of Medical Sciences, Bhubaneswar