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CTRI Number  CTRI/2018/06/014457 [Registered on: 07/06/2018] Trial Registered Retrospectively
Last Modified On: 06/06/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Use of keyhole surgery in pain abdomen 
Scientific Title of Study   Role of Laparoscopy in Acute Abdomen 
Trial Acronym  LAB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MAYANK NARANI 
Designation  SENIOR RESIDENT 
Affiliation  Dr. Ram Manohar Lohia Hospital Post Graduate Institute of Medical Education and Research 
Address  Dr. Ram Manohar Lohia Hospital Post Graduate Institute of Medical Education and Research A Central Government Hospital
Department of General Surgery Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi, Delhi 110001
New Delhi
DELHI
110001
India 
Phone  919811887880  
Fax    
Email  mayank_narani@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  DR ALOK AGRAWAL 
Designation  SENIOR CONSULTANT 
Affiliation  MAHARAJA AGRASEN HOSPITAL 
Address  MAHARAJA AGRASEN HOSPITAL DEPARTMENT OF GENERAL SURGERY & MINIMAL ACCESS SURGERY
WEST PUNJABI BAGH, NEW DELHI – 110026
West
DELHI
110092
India 
Phone  9810622722  
Fax    
Email  dralokagrawal@yahoo.com  
 
Details of Contact Person
Public Query  
Name  MAYANK NARANI 
Designation  SENIOR RESIDENT 
Affiliation  Dr. Ram Manohar Lohia Hospital Post Graduate Institute of Medical Education and Research 
Address  Dr. Ram Manohar Lohia Hospital Post Graduate Institute of Medical Education and Research A Central Government Hospital
Department of General Surgery Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi, Delhi 110001
New Delhi
DELHI
110001
India 
Phone  919811887880  
Fax    
Email  mayank_narani@yahoo.co.in  
 
Source of Monetary or Material Support  
MAHARAJA AGRASEN HOSPITAL PUNJABI BAGH, NEW DELHI- 110026 
 
Primary Sponsor  
Name  MAHARAJA AGRASEN HOSPITAL 
Address  PUNJABI BAGH, NEW DELHI-110026 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR MAYANK NARANI  MAHARAJA AGRASEN HOSPITAL  DEPARTMENT OF GENERAL SURGERY & MINIMAL ACCESS SURGERY MAHARAJA AGRASEN HOSPITAL ROHTAK ROAD, WEST PUNJABI BAGH
West
DELHI 		 9811887880

mayank_narani@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE MAHARAJA AGRASEN HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  SURGICAL ACUTE ABDOMEN,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL   NIL  
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Acute abdominal pain of recent onset.
2. Patients whose age is 14 years and above.
3. Patients giving consent for surgical procedure.
 
 
ExclusionCriteria 
Details  1. Uncontrolled coagulopathy.
2. Haemodynamically unstable patients.
3. Patients presenting with chronic abdominal pain.
4. Patients having undergone multiple previous abdominal procedures.
5. Patients refusing the minimal access technique (diagnostic laparoscopy) for diagnosis.
6. Other causes which exclude laparoscopy in acute abdomen. (e.g. multiple stab wounds)
7. Patients undergoing elective procedures.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
50 patients with surgical acute abdomen were selected for this study.
The pre- operative diagnosis was compared with laparoscopic diagnosis to evaluate accuracy of diagnostic laparoscopy. With the use of diagnostic laparoscopy a diagnosis could be reached in 49 (98%) cases. It confirmed the diagnosis in 35 (70%) patients.In 14 patients (28%) laparoscopy changed the diagnosis.  		 The Laparoscopic/ post operative diagnosis was compared with pre- operative diagnosis after each procedure. 
 
Secondary Outcome  
Outcome  TimePoints 
In our series 28 (56%) laparoscopic appendectomy were performed.
Therapeutic laparoscopy was done in 37 (74%) cases. Lap assisted procedure were done in 4 (8%) cases. 8 (16%) cases required conversion to open procedure. Hence, the conversion rate was 16%. The main causes for conversion were due to extensive adhesions, distended bowel. 		 For feasibility of laparoscopy for management of acute abdomen 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2014 
Date of Study Completion (India) 31/08/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NOT YET PUBLISHED OR SUBMITTED FOR PUBLICATION 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Acute abdomen continues to be the commonest complaint for emergency surgical admission and demands a large portion of the general surgeons workload. Patients selected for this study were admitted with surgical causes of acute abdomen. Based on clinical history and examination, relevant investigations of patients with acute abdomen were done. A detailed proforma was used to collect this information. After initial assessment and informed written consent, they were subjected to laparoscopy. All patients were informed about the risk and benefit of procedure and also about the probability of laparotomy if need arose.

The preoperative diagnosis was compared with laparoscopic diagnosis to evaluate accuracy of diagnostic laparoscopy. Wherever possible, therapeutic procedure was undertaken. If the therapeutic procedure required conversion to open procedure (laparotomy) the same was done. The patients were managed in Intensive Care Unit or surgical wards. The patients were followed postoperatively till 6 months.The patient were thus divided into three groups after undergoing diagnostic laparoscopy. The patients undergoing therapeutic laparoscopy, those who had laparoscopic assisted procedure done and those patients on whom laparoscopy was converted to laparotomy. The parameters compared were operating time, hospital stay and complication.

Diagnostic laparoscopy was found to be more accurate than preoperative diagnosis. Laparoscopy was found to decrease the time of procedure and duration of hospital stay. By exact diagnosis, diagnostic laparoscopy prevents non- therapeutic laparotomy. Laparoscopic assisted procedures also serve as a bridge between laparoscopy and laparotomy as it reduces operating time and their is faster postoperative recovery. Laparoscopy is an helpful tool for the diagnosis and treatment of surgical abdominal emergencies in patients especially in right lower abdominal pain, small bowel pathology and gallbladder and liver pathologies. The usage of laparoscopy is further widened by its application in the case of abdominal trauma.

Laparoscopy was found to be of great diagnostic value and a therapeutic procedure was feasible in significant number of patients. Moreover, observation on laparoscopy changed the further course of management in several cases.
 
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