| CTRI Number |
CTRI/2018/01/011064 [Registered on: 01/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
27/09/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
A single hospital study on the occurrence of leaks between anastomosis of small and large bowel. |
|
Scientific Title of Study
|
Ileocolic Anastomotic Leaks - An Institutional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Kalyan Reddy Janumpalli |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, manipal |
| Address |
Department of General Surgery,
Third floor,
Smt.Sharada Madhav Pai OPD,
Kasturba Hospital,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105135208 |
| Fax |
|
| Email |
kalyanreddy@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Rajgopal Shenoy |
| Designation |
Professor and Associate Dean |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room No.2,
Department of General Surgery,
Smt.Sharada Madhav Pai OPD,
Kasturba Hospital,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
kallyarajgopalshenoy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Kalyan Reddy Janumpalli |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, manipal |
| Address |
Department of General Surgery
Third floor
Smt.Sharada Madhav Pai OPD
Kasturba Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105135208 |
| Fax |
|
| Email |
kalyanreddy@outlook.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,
Madhav Nagar,
Manipal-576104,
Karnataka,
India |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Madhav Nagar, Manipal, Karnataka |
| Type of Sponsor |
Private 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 Krishna Kalyan Reddy Janumpalli |
Kasturba Hospital, Manipal |
Department of General Surgery,
Third Floor,
Smt.Sharada Madhav Pai OPD,
Kasturba Hospital,
Manipal-576104
Udupi
KARNATAKA |
8105135208
kalyanreddy@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC & KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Any disease condition requiring surgery in the form of ileocolic anastomosis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Colectomy (radical/limited) with Ileocolic Anastomosis
End ileostomy reversal with Ileocolic Anastomosis
|
|
| ExclusionCriteria |
| Details |
Patients who underwent Ileocolic Anastomosis elsewhere and were referred to Kasturba Hospital with Anastomotic Leak
Patients with Ileocolic Anastomosis with Diversion Loop Ileostomy
Patients with Ileorectal Anastomosis
Patients with Ileal pouch Anal Anastomosis
Age below 18 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The objective is to investigate any association between the variables considered and the occurrence of Anastomotic Leak.
Age
Coexisting illness
Preoperative Albumin
Indication for surgery
Nature of surgery
Preoperative bowel preparation
Technique of anastomosis
Type of anastomosis
Intraoperative complications
Experience of the surgeon
Duration of surgery
Mode of diagnosis of leak
Time of diagnosis of leak after surgery
Management of leak
|
The occurrence of leak within 30 days of the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyze how anastomotic leaks affect hospital stay |
Hospital stay is measured in terms of total number of days the patient was admitted in the hospital |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="224" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/12/2016 |
| Date of Study Completion (India) |
31/01/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Anastomotic leak is the most feared complication following intestinal resection with incidence varying between 1.8%1 and 15.9%. Anastomotic leakage is associated with the need for re-operation, prolonged hospital stay and increased morbidity and mortality. Controversy surrounds the list of risk factors associated with Anastomotic Leaks with preoperative Serum Protein concentration being found to be an independent risk factor. The influence of surgeon factors over the occurrence of anastomotic leaks has found little evidence. Multiple reoperations and stoma creation are often necessary to control the leak, which significantly increases health risks and health care costs. Hence knowledge about risk factors predisposing patients to Anastomotic Leak will be helpful in early detection and management of an otherwise fatal complication.
|