| CTRI Number |
CTRI/2023/01/048969 [Registered on: 13/01/2023] Trial Registered Prospectively |
| Last Modified On: |
01/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The effects of a laparoscopically inserted feeding tube in the intestine in persons who have had completely blocked food pipe |
|
Scientific Title of Study
|
A Retrospective study of our technique of laparoscopic feeding jejunostomy tube placement |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjunath Maruti Pol |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9990187137 |
| Fax |
|
| Email |
manjunath.pol123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghav Garg |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9811551377 |
| Fax |
|
| Email |
drraghavgarg1248@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raghav Garg |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9811551377 |
| Fax |
|
| Email |
drraghavgarg1248@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Surgical Disciplines AIIMS New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi |
| 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 |
| Manjunath Maruti Pol |
AIIMS Delhi |
Department of Surgical Disciplines, first floor,B-1 ward, Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
South
DELHI |
9990187137
manjunath.pol123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K228||Other specified diseases of esophagus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.18 to 70 years of age, both male and female
2. Indications for feeding jejunostomy
a) corrosive oesophageal injury
b) upper gastrointestinal malignancies (Ca. Esophagus, Ca stomach, Ca head ofpancreas, Ca duodenum):
• Obstructed inoperable or metastatic
• Locally advanced (planned for neoadjuvant chemotherapy): staging laparoscopy
• Nutritional conditioning required prior to curative procedure |
|
| ExclusionCriteria |
| Details |
1. Age < 18 years and > 70 Years
2. Pregnancy
3. Refusal to consent or participate in the study
4. It is possible to insert nasogastric tube (or orogastric) tube either blind bedside orendoscopic guided technique.
5. Prior abdominal surgery
6. Undergone PEG or feeding jejunostomy in the past
7. Active Inflammatory bowel disease
8. Hypotension (blood pressure < 90/60 mmHg) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the technical feasibility and safety of Laparoscopic feeding jejunostomy |
Immediately after completion of surgery to 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total operative time
2. Haematoma and Intra-operative blood loss
3. Catheter related complications: blockage / kink/ displacement / dislodgement
4. Surgical Site Infection
5. Bowel related complications: bowel obstruction / ischaemia
6. Duration of Post-Operative Hospital Stay
7. Re exploration
8. Mortality |
. In minutes
2. In millilitre
3. In 30 days
4. In 30 days
5. In 30 days
6. In days
8. in 30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/01/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
According
to Mastoridis et al.’s (2021) retrospective study, laparoscopic feeding
jejunostomy is a feasible and safe procedure that provides the benefits of
minimally invasive surgery. Since the first reported totally laparoscopic
feeding jejunostomy, several techniques for laparoscopic feeding jejunostomy
have been described. Most of them used costly commercial kits and complex
suturing techniques. However, there is no standard technique proposed for the
creation of laparoscopic FJ. Thus, there is a need to simplify this technique
in a way that reduces the learning curve and makes it cost-effective without
increasing complications.
1. Mastoridis S, Bracalente G, Hanganu CB, et al.
Laparoscopic vs. open feeding jejunostomy insertion in oesophagogastric cancer.
BMC Surg. 2021 Oct 13;21(1):367 |