| CTRI Number |
CTRI/2024/07/071362 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Factors predicting postoperative outcomes in patients with Perforation Peritonitis |
|
Scientific Title of Study
|
Predictors of postoperative outcome in emergency laparotomy for perforation peritonitis-A prospective cross sectional study |
| 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 POOSARLA RAM SOHAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Department of General Surgery,Acharya Vinobha Bhave Rural Hospital,Jawaharlal Nehru Medical College,DMIHER,Sawangi Meghe,Wardha 442004,Maharashtra,India
Wardha
MAHARASHTRA
442107
India |
| Phone |
8500252484 |
| Fax |
|
| Email |
poosarlaramsohan138@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.C.Mahakalkar |
| Designation |
professor |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Department of General Surgery,Acharya Vinobha Bhave Rural Hospital,Jawaharlal Nehru Medical College,DMIHER,Sawangi Meghe,Wardha 442004,Maharashtra,India
Wardha
MAHARASHTRA
442004
India |
| Phone |
9822369277 |
| Fax |
|
| Email |
cmahakalkar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR POOSARLA RAM SOHAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Department of General Surgery,Acharya Vinobha Bhave Rural Hospital,Jawaharlal Nehru Medical College,DMIHER,Sawangi Meghe,Wardha 442004,Maharashtra,India
Wardha
MAHARASHTRA
442004
India |
| Phone |
8500252484 |
| Fax |
|
| Email |
poosarlaramsohan138@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education And Research ,SAWANGI MEGHE,Wardha |
|
|
Primary Sponsor
|
| Name |
Poosarla Ram Sohan |
| Address |
Deparatment Of General Surgery,Acharya Vinobha Bhave Rural Hospital,Jawaharlal Nehru Medical College,DMIHER,SAWANGI,WARDHA-442107 |
| 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 Poosarla Ram Sohan |
Acharya Vinobha Bhave Rural Hospital |
Department of General Surgery,Acharya Vinobha Bhave Rural Hospital,Jawaharlal Nehru Medical College,DMIHER,Sawangi Meghe,Wardha 442004,Maharashtra,India
Wardha
MAHARASHTRA |
8500252484
Poosarlaramsohan138@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, Re-regd. no.: ECR/440/InsUMH/2013/RR-2019 Sawangi (MEGHE),Wardha-442107,MAHARASHTRA,India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Gastric Perforation
2.Patients with Gallbladder Perforation
3.Patients With Duodenal Perforation
4.Patients with Jejunal Perforation
5.Patients with Ileal Perforation
6.Patients with Caecal Perforation
7. Patients with Appendicular Perforation 8. Patients with Colonic Perforation
9. Patients with Rectal Perforation |
|
| ExclusionCriteria |
| Details |
1.Pregnancy/Puerperium
2.Know case of Diabetes mellitus
3.Malignancies
4.Patients on immunosuppressive theory
5.Patients infected with Hepatitis B and C virus as well as HIV |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To predict postoperative anastomotic leak.
2.To Analyse postoperative complications.
3.To assess post operative mortality. |
2 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To compare the postoperative outcome in patients who underwent exploratory laparotomy |
2 years |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
02/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gastrointestinal tract perforation is one of the most common surgical emergencies worldwide. Peritonitis causing the sepsis and systemic complications due to the perforation are still responsible for significant mortality despite the advent of newer antibiotics, safe operative and anaesthetic techniques, and an improved understanding of pre and postoperative management . Rapid source control through surgical exploration and prudent antimicrobial therapy is fundamental for treating intra-abdominal sepsis due to perforation. Billing et al. proposed early prognostic assessment of patients with perforation peritonitis to allow triaging of patients for a more aggressive therapeutic approach . Several scoring systems have since been developed to enable general and prognostic evaluation of patients with perforation peritonitis . Bohen et al. did an anatomical classification of intra-abdominal infections into three groups (group I- appendicitis and perforated duodenal ulcer; group II- peritonitis from all other intra-abdominal organs, not following surgery; and group III- postoperative peritonitis) and showed a difference in outcomes between them. The Acute Physiology and Chronic Health Evaluation (APACHE) system, on the other hand, is a non-specific physiologic scoring system that has been validated for risk stratification and has also been used in several studies for intra-abdominal infections . Meakins and associates proposed an approach for the study and clinical management of intra- abdominal infections that combined functional and anatomical components. Singh et al. did a prospective analysis of 84 patients with perforation peritonitis and identified laboratory indices, delay in presentation, and surgery as good predictors of postoperative mortality. Most of these scoring systems are exhaustive and challenging to use in emergency departments. This study aimed to evaluate the predictive factors of postoperative outcome in patients undergoing emergency laparotomy for perforation peritonitis. |