Impact of Abdominal Drains on the ERAS Pathway in Peptic Perforation

NCT05368233 | Unknown

• 1 other identifier: PG Thesis/2021-22/111
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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. .

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

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay (in days)

  Duration from the time of operation to time of discharge

  Post operative period up-to one month.

Secondary Outcomes (7)

• Early postoperative abdominal pain measured using the Verbal numeric scale (VNS)

  At 8 hours, 24 hours and 72 hours postoperatively

• Time of recovery of Functional parameters (in hours)

  Up to one month post operatively

• Incidence of Complications

  Up-to one month post operatively

• Need for re-intervention in either arm

  Up-to one month post operatively

• Re-admission rates

  Date of discharge to 1 month post operative period

Study Arms (2)

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.

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.

Other: ERAS protocol

Interventions

ERAS protocol OTHER

ERAS protocol whch helps to optimise the length of hospital stay.

Also known as: Fast track study

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

All India Institute of Medical Sciences,

Bhubaneswar, Odisha, 751020, India

RECRUITING

Related Publications (4)

• 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.

  PMID: 24119887 RESULT

• 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.

  PMID: 28653239 RESULT

• 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.

  PMID: 30842811 RESULT

• 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.

  PMID: 27509704 RESULT

MeSH Terms

Conditions

Peptic Ulcer Perforation; Intestinal Perforation; Postoperative Complications; Emergencies

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• TUSHAR S MISHRA, MBBS,MS,FACS

  All India Institute of Medical Sciences, Bhubaneswar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TUSHAR S MISHRA, MBBS,MS,FACS

CONTACT

+91 9438884251; surg_tushar@aiimsbhubaneswar.edu.in

ANKIT RANA, MBBS

CONTACT

+91 7018212942; ankitrana124@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: May 10, 2022
• Study Start: June 15, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)