| CTRI Number |
CTRI/2021/04/032621 [Registered on: 07/04/2021] Trial Registered Prospectively |
| Last Modified On: |
17/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nursing ] |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Nursing interventions on postoperative recovery among patients undergoing abdominal surgery |
|
Scientific Title of Study
|
Effectiveness of an enhanced surgical recovery nursing program on postoperative outcomes of patients undergoing abdominal surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hezil Reema Barboza |
| Designation |
Ph.D Scholar/Lecturer |
| Affiliation |
Yenepoya Nursing College |
| Address |
Department of Medical Surgical Nursing,
Yenepoya Nursing College,
Yenepoya (Deemed to be University)
University Road, Deralakatte
Mangalure
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09008218663 |
| Fax |
|
| Email |
hezilreemabarboza@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hezil Reema Barboza |
| Designation |
Ph.D Scholar/Lecturer |
| Affiliation |
Yenepoya Nursing College |
| Address |
Department of Medical Surgical Nursing,
Yenepoya Nursing College,
Yenepoya (Deemed to be University)
University Road, Deralakatte
Mangalure
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09008218663 |
| Fax |
|
| Email |
hezilreemabarboza@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hezil Reema Barboza |
| Designation |
Ph.D Scholar/Lecturer |
| Affiliation |
Yenepoya Nursing College |
| Address |
Department of Medical Surgical Nursing,
Yenepoya Nursing College,
Yenepoya (Deemed to be University)
University Road, Deralakatte
Mangalure
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09008218663 |
| Fax |
|
| Email |
hezilreemabarboza@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital, Deralakatte, Mangalure |
|
|
Primary Sponsor
|
| Name |
Hezil Reema Barboza |
| Address |
Yenepoya Nursing College
Yenepoya Deemed to be University
Unierssity Road, Mangalure |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Fatima Dsilva |
Yenepoya Medical College Hospital |
Department of Surgery,
4th Floor
Dakshina Kannada
KARNATAKA |
9980645781
ftds_1970@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Enhanced surgical recovery nursing program which includes preoperative education, deep breathing exercises, music listening,early mobilization and early feeding in the cooperatively, lower extremity exercises |
o Preoperative education: It is a structured preoperative teaching plan given to the patients individually regarding different aspects of surgery such as preoperative preparation, anesthesia, surgery, orientation to surgical suite, postoperative care, exercises and discharge plan for 20 min using audiovisual aids.
o Music: Listening to patient preference music (instrumental/nature) in the preoperative and postoperative period in the evening one time in a day for duration of 15 min through headphone. Patient is asked to select the type of music (instrumental or nature).
o Abdominal and diaphragmatic breathing: It refers to practice of deep breathing during preoperative and postoperative period in sitting position for 15 min 1 time in the morning .
o Early feeding: It refers to initiation of oral feed in 4-6 hours following surgery. Leg exercise:
Ankle: Bend and stretch the ankle up and down firmly and quickly. Repeat for 10 times with each leg.
Knees: Tighten the thigh by pushing the back of knees down against the bed. Hold for 5 seconds. Repeat 5 times with each leg.
Pull the toes up, tighten the thigh muscle and straighten the knee. Hold for seconds and relax slowly. Repeat 5 times with each leg.
o Early mobilization: Refers to incremental activities performed by the patient in the presence of investigator which will be started within 24 hours of surgery. It involves lower extremity exercises, sitting position, dangling, out of bed, sitting in a chair and walking.. |
| Comparator Agent |
Routine treatment |
Routine treatment includes usual method of preoperative care in the surgical unit such as performing laboratory test, obtaining informed consent, skin preparation, bowel clearance, psychological preparation based on patient needs and premedication for anxiety. The standard care includes administration of premedication to relieve anxiety and prophylactic intravenous antibiotic therapy will be given in the preoperative phase. Postoperative phase includes analgesics for the pain management and continuation of antibiotic therapy |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective laparotomy surgery
Surgeries involving organs such as stomach, intestine, pancreas, gall bladder, spleen (appendectomy, liver transplantation, gastrectomy cholecystectomy, colon and small bowel resection, hernia repair, pancreatectomy, splenectomy, Whipple procedure
Age between 20 – 60 years
With no hearing impairment
Able to communicate in Kannada/ English
Hospitalized 2 days prior to surgery and available for 3-5 days after the surgery
|
|
| ExclusionCriteria |
| Details |
Patients who are critically ill
Patients undergoing laparoscopic surgery and robotic surgeries
With impaired consciousness
With psychiatric disorders
On chronic treatment with analgesics
Who have undergone surgery in the past
Cesarean section, aortic femoral bypass and abdominal hysterectomy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Enhanced Surgical recovery |
Baseline- Preoperatively 2 days before surgery
Postoperative day 1
Postoperative day 2
Postoperative day 3
Postoperative day 4
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Less postoperative complications
high level of perioperative patient satisfaction
|
On the day of discharge from hospital |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Perioperative phase
includes a variety of procedures and practices that aim to prepare the patient,
physically and psychologically and prevent postoperative complications, thereby
reducing the length of hospital stay. Enhanced recovery or Multimodal Rehabilitation Programs (MMRH) or ERAS (Enhanced Recovery After Surgery), is a revised traditional care intervention in order to rationalize
perioperative treatment and thus improve the postoperative course of the
patient. These programs include the application of various perioperative
measures and strategies and the active participation of the patient in this
process. Enhanced recovery is currently considered to be the treatment of various
elective major surgeries. In order to prepare a standard nursing practice while caring for a patient
undergoing abdominal surgery, the investigator found the need for an enhanced
recovery program to improve the postoperative outcomes.
|