Clinical trial NCT05368233: Impact of Abdominal Drains on the ERAS Pathway in Peptic Perforation
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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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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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of hospital stay (in days)
timeFrame: Post operative period up-to one month.
Secondary outcomes:
measure: Early postoperative abdominal pain measured using the Verbal numeric scale (VNS)
timeFrame: At 8 hours, 24 hours and 72 hours postoperatively
measure: Time of recovery of Functional parameters (in hours)
timeFrame: Up to one month post operatively
measure: Incidence of Complications
timeFrame: Up-to one month post operatively
measure: Need for re-intervention in either arm
timeFrame: Up-to one month post operatively
measure: Re-admission rates
timeFrame: Date of discharge to 1 month post operative period
measure: Quality of life scoring and assessment
timeFrame: Post operative period - at 48 hours after surgery, at one month follow up and at third month follow up.
measure: Degree of compliance to the ERAS protocol
timeFrame: Up to the time of discharge
Other outcomes:
Locations:
city: Bhubaneswar
country: India
facility: All India Institute of Medical Sciences,
state: Odisha
Study officials:
affiliation: All India Institute of Medical Sciences, Bhubaneswar
name: TUSHAR S MISHRA, MBBS,MS,FACS
role: PRINCIPAL_INVESTIGATOR
References:
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. Epub 2013 Oct 10.
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/s11605-017-3474-2. Epub 2017 Jun 26.
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.
citation: 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.