A pilot study on Enhanced Recovery After Surgery (Fast track recovery) protocol in patients undergoing stomach surgery for cancer
- Conditions
- Malignant neoplasm of stomach, unspecified,
- Registration Number
- CTRI/2020/10/028216
- Lead Sponsor
- Cancer Institute WIA Adyar Chennai
- Brief Summary
Current protocol followed in the unit
1. Initiated on incentive spirometry before surgery
2. Nil by mouth night before surgery
3. No pre-operative carbohydrate loading
4. Pre-anaesthetic medications including benzodiazepine and acid H2 blockers are given to all patients
5. No emphasis on balanced fluid therapy
6. Placement of two drains in all patients ( one near duodenal stump and other near the anasotomosis GJ/EJ)
7. Nasogastric tube kept at-least up to postoperative day 3
8. Jejunostomy feed initiated only on postoperative day 1
9. Oral liquids initiated only on or after postoperative day 4
10. Urinary catheter removal on postoperative day 2
11. Ambulation only on day 2
12. Removal of abdominal drain when output<50 ml and serous
13. Discharge as per surgeon discretion
Proposed changes in ERAS protocol study (new additions to existing protocol are in bold font)
Preoperative management
All patients deemed fit to undergo radical gastrectomy and fulfilling the inclusion criteria are considered for inclusion in the study and given detailed information regarding the study.
If receptive, they will be handed over the patient information sheet having detailed layout of the study. A written informed consent will be obtained.
Preoperative preparation of study subjects include the following (implemented at the time of OPD visit, when the treatment plan had been finalized)
1. Incentive spirometry initiated(includes atleast two sessions with physiotherapist)
2. Daily walk: 2 flights of stairs up and down thrice daily (if the patient’s performance status permitted)
3. High protein high calorie diet (solid/semisolid/liquid as tolerated)/total calorie requirement (as assessed by the hospital dietician.)
4. Patient advised to stop smoking/chewing tobacco
Day prior to surgery
1. No preoperative medications
2. Regular diet, night before surgery (except patients who have gastric outlet obstruction)
3. Preop dose of anticoagulants (LMWH/UFH) night before surgery at 7pm
On the day of the surgery
1. Carbohydrate drink 2-3 hours prior to surgery
2. Preoperative antibiotic immediately prior to surgery: Injection Cefuroxime 1.5 gm iv stat AST
3. Placement of thoracic epidural catheter at T7-9 level
4. Prevention of intraoperative hypothermia by use of body warming blankets
5. Minimize blood loss/blood transfusion (blood transfusion trigger of Hb 8 gm/dl)
6. Conservative intraoperative fluid management
7. Only one drain will be placed on the right side.
Postoperative
1. Patient sitting up in bed on the evening of surgery or out of bed the coming morning, in case surgery ends in the evening
2. High flow oxygen support for at least six hours postoperatively
3. Balanced Intravenous Fluids with use of balanced crystalloids
POD 1
1. Patient out of bed and moves around the bed
2. Thoracic epidural analgesia
3. Chest physiotherapy and incentive spirometry reinitiated.
4. Jejunostomy trial feed (if jejunostomy performed) initiated if patient is hemodynamically stable at 30 ml/ hr for 10 hours.
5. Nasogastric tube removed
6. Oral sips initiated
POD 2
1. Analgesia: Thoracic epidural as before with intravenous paracetamol
2. Chest physiotherapy and spirometry
3. Patient to walk 100 feet with/ without support if tolerated
4. Per urethral catheter removed if point 3 achieved
5. Jejunostomy feeds start at 30 ml/hr escalate to 50 ml/hr based on patient tolerance
6. Oral clear liquids allowed upto 1000ml
7. Drain will be removed if output in last 24 hours is <200mland clear (if >200ml, the drains will be retained and removed whenever output is less than 200 ml)
8. Antibiotics stopped
POD 3
1.
2. Thoracic epidural catheter removed
3. Clear Oral liquids2000ml allowed
4. Chest physiotherapy/ spirometry
5. Jejunostomy feeds increased to the patient’s caloric requirement
6. Intravenous fluids and analgesics discontinued and enteral analgesics started sos(through jejunostomy)
7. Patient encouraged to remain freely mobile beyond 100 feet
POD 4
1. Full Oral liquidsallowed
2. Oral hygiene/chest physiotherapy /spirometry continued
3. Jejunostomy feed continued
4. Counselling for post discharge care/supplemental feeds at home
POD 5
1. Soft solids initiated by mouth
2. Jejunostomy feed supplementation sos
3.
POD 6 and beyond
1. Soft diet escalated to normal diet
2. evaluated for discharge after the discharge criteria are met
Withholding of ERAS protocol
1. Patients who are not extubated after the surgery – ERAS protocol will not be implemented until at least 6 hours after extubation.
2. Patients who are hypothermic (axillary temperature < 36.5o C)
3. Patients who are haemodynamically unstable i.e on inotropes – ERAS protocol will not be implemented at least until 6 hours after cessation of inotropes
Criteria to shift out of ICU/HDU
1. No haemodynamic events (hypotension) or requirement of inotropes for 24 hours
2. No requirement for intensive monitoring
Discharge criteria
1. No fever for 48 hr
2. No tubes (except feeding jejunostomy)
3. Total calorie requirement met with peroral ± Jejunostomy supplementation
4. Freely mobile
All perioperative outcome measures will be recorded in the proforma and ERAS checklist. In case of failure to achieve any or all of the endpoints, the reason for the same will be recorded. The complications will be graded as per Clavien-Dindo scale
Follow up protocol
Patients will be followed up for 30 days post operatively or day of discharge whichever comes laterand standard assessment and any complication requiring outpatient, out of protocol investigation/ intervention/ readmission will be recorded apart from complications of adjuvant therapy. Defaulters will be called to ensure the follow up regimen, need for postoperative adjuvant treatment will also be finalized during this period.
Data Collection Pre-operative, intraoperative and postoperative data will be collected as per proforma.
Sample size
Being a pilot study, we will recruit 20 patients in to the study. Historical controls will be selected from patients who underwent subtotal gastrectomy in the institute between 2015 to 2019 and propensity score matching will be done to compare matched samples for the secondary outcomes.
Suggested plan of action for utilization of research outcome expected from the project
If the outcomes of this study show feasibility in our set up with favourable patient outcomes , then we will implement ERAS as a routine protocol in all patients undergoing elective subtotal gastrectomy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 20
- All patients planned for elective subtotal gastrectomy for distal gastric cancer 1.
- Age: 18-65 years 2.
- Able to understand the protocol and willing to follow them 5.
- Patients willing to stay in Chennai for upto 2 weeks after discharge.
- Patients undergoing total or extended total gastrectomy 2.
- Patients undergoing multiorgan resection 3.
- Patients undergoing Palliative surgery 4.
- Patients not giving consent 5.
- Emergency surgery.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure will be the compliance to the protocol. till last the patient (total 20 patients complete study protocol)
- Secondary Outcome Measures
Name Time Method The secondary outcome measuresincludeduration of hospital stay,30-day readmission rate, and 30-day postoperative complication rate till last the patient (total 20 patients complete study protocol)
Trial Locations
- Locations (1)
Cancer Institute(WIA)
🇮🇳Chennai, TAMIL NADU, India
Cancer Institute(WIA)🇮🇳Chennai, TAMIL NADU, IndiaDr Pradeep Jeyakumar SPrincipal investigator9592996431pjksgeon1@gmail.com