| CTRI Number |
CTRI/2025/03/083435 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Feasibility of performing Laparoscopic Interval Appendicectomy as a day care procedure. |
|
Scientific Title of Study
|
Feasibility of Day Care Laparoscopic Interval Appendicectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Matiz Hossain |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College , New Delhi. |
| Address |
Department of Surgery, Maulana Azad Medical College , New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
8700497328 |
| Fax |
|
| Email |
matizhossain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Chandra Bhushan Singh |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College , New Delhi. |
| Address |
Department of Surgery, Maulana Azad Medical College , New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
9717212602 |
| Fax |
|
| Email |
drchandrabhushansingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Matiz Hossain |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College , New Delhi. |
| Address |
Department of Surgery, Maulana Azad Medical College , New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
9717212602 |
| Fax |
|
| Email |
matizhossain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Surgery,Maulana Azad Medical College, New Delhi, Delhi-110002, India. |
|
|
Primary Sponsor
|
| Name |
Department of Surgery Maulana Azad Medical College New Delhi |
| Address |
Maulana Azad Medical College, New Delhi, Delhi-110002, India. |
| Type of Sponsor |
Government medical college |
|
|
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 MATIZ HOSSAIN |
Maulana Azad Medical College and Lok Nayak Hospital |
Department of Surgery, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi.
New Delhi
DELHI |
8700497328
matizhossain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and associated Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K358||Other and unspecified acute appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group from 18-65 years.
2. Motivated to undergo day care surgery.
3. Patients fulfilling the criteria for day care surgery. (as per ASA Guidelines for Ambulatory Anesthesia and Surgery)
|
|
| ExclusionCriteria |
| Details |
1. BMI of more than 35 kg/m2
2. Pregnancy.
3. Coagulation Disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasibility of performing Laparoscopic Interval Appendicectomy as a daycare procedure as per ASA guideline for Ambulatory Aneasthesia and Surgery. |
1 Postoperative day 0
2 Postoperative day 2 to 5
3 Postoperative day 7
4 Postoperative day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Incidence of post operative pain
2 Incidence of post operative complications
3 Duration of hospital stay in hours
4 Time taken to resume activities of daily living.
5 Patient satisfaction score
|
1 Postoperative day 0
2 Postoperative day 2 to 5
3 Postoperative day 7
4 Postoperative day 14 |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
07/04/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The primary aim of day-care surgery units is to allow for early recovery of the patients so that they can return to their home environment. While much has been done internationally, there is an immense opportunity for expansion in day-care surgery in India to ensure faster and safer, cost-effective patient turnover. Performing a successful and efficient day surgery not only includes appropriate patient selection but also their timely discharge. Studies have proven laparoscopic appendicectomy to be a safe procedure associated with shorter hospital stay and decreased complication rates as compared to the open procedure. This is mostly due to improved post-operative course and reduced complication rate, especially from the wound site, which is a serious problem in this group of patients. The low rate of adverse events or complications during the intraoperative or immediate postoperative periods has further encouraged the acceptance of ambulatory surgeries. Nowadays, improved surgical instruments, less invasive surgical techniques, a team approach in preparing a person for surgery and home recovery that involves both a surgeon and an anaesthesiologist, newer anaesthesiÄ… practice and newer anaesthesia drugs allow patients to recover faster after surgery and allows their timely discharge. Early discharge allows early return of patients to their normal lifestyle and also allows a greater institutional turnover of patients, benefiting the patients as well as the overall health care. |