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CTRI Number  CTRI/2024/10/075571 [Registered on: 21/10/2024] Trial Registered Prospectively
Last Modified On: 19/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Two Methods for Safer Laparoscopic Gallbladder Stone Surgery A Study on Between Two Techniques  
Scientific Title of Study   Comparative efficacy of body first versus conventional techniques in achieving critical view of safety in laparoscopic cholecystectomy a single blinded block randomized controlled trial 
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 Jagani Harsha Sai 
Designation  Junior resident 
Affiliation  All India Institute of Medical Sciences Gorakhpur  
Address  Department of General Surgery All India Institute of Medical Sciences Gorakhpur

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  6301755396  
Fax    
Email  prasadleelajagani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ravi Gupta 
Designation  Associate Professor of Surgery 
Affiliation  All India Institute of Medical Sciences Gorakhpur  
Address  Department of General Surgery All India Institute of Medical Sciences Gorakhpur

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9453302264  
Fax    
Email  ravikgmc2004@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ravi Gupta 
Designation  Associate Professor of Surgery 
Affiliation  All India Institute of Medical Sciences Gorakhpur  
Address  Department of General Surgery All India Institute of Medical Sciences Gorakhpur


UTTAR PRADESH
273008
India 
Phone  9453302264  
Fax    
Email  ravikgmc2004@gmail.com  
 
Source of Monetary or Material Support  
Department of General Surgery All India Institute of Medical Sciences Kunraghat Gorakhpur Uttar Pradesh Country India Pincode 273008 
 
Primary Sponsor  
Name  Dr Jagani Harsha Sai 
Address  All India Institute of Medical Sciences Gorakhpur Uttar Pradesh India 
Type of Sponsor  Other [self] 
 
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 Jagani Harsha Sai  All India Institute of Medical Sciences Gorakhpur   Department of General Surgery All India Institute of Medical Sciences Gorakhpur
Gorakhpur
UTTAR PRADESH 
6301755396

prasadleelajagani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee All India Institute of Medical Sciences Gorakhpur India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Body First Approach of Laparoscopic Cholecystectomy  Patients in this group will undergo Laparoscopic cholecystectomy by Body First Approach under general anesthesia and sterile conditions, pneumoperitoneum is created, followed by the placement of a 10 mm umbilical port for diagnostic laparoscopy. Additional ports (5 mm anterior axillary 10 mm epigastric and 5 mm subcostal) are placed to retract the gallbladder and provide access. Anatomical landmarks such as the hepatoduodenal ligament and hepatocystic triangle are identified. and pre-dissection photography is taken. Posterior dissection begins away from Calots triangle, creating a window by separating the gallbladder body from the cystic plate to achieve the critical view of safety . Cystic artery and duct variations are documented and both are clipped and divided. The gallbladder is removed and after ensuring hemostasis and no bile staining all ports are closed with sutures and an aseptic dressing is applied. Approximate Duration of procedure is 60 to 90 minutes 
Comparator Agent  Conventional Approach of Laparoscopic Cholecystectomy  Patients in this group will undergo Laparoscopic cholecystectomy by Conventional Approach under general anesthesia and sterile conditions pneumoperitoneum is created followed by a 10 mm umbilical port for diagnostic laparoscopy. Additional ports (5 mm anterior axillary 10 mm epigastric and 5 mm subcostal) are placed for gallbladder retraction and access. Key anatomical landmarks are identified and pre-dissection photography is taken. Dissection starts with anterior and posterior peritoneal folds followed by dissection Around the infundibulum in Calots triangle to expose the cystic duct and cystic artery. The critical view of safety is achieved and variations in cystic artery and duct anatomy are documented. Both the cystic artery and duct are clipped and cut and the gallbladder is dissected from the gallbladder bed. After confirming hemostasis and no bile leakage the gallbladder is removed through the umbilical/epigastric port. Ports are closed with absorbable sutures and an aseptic dressing is applied. Approximate Duration of procedure is 60 to 90 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients scheduled for elective Laparoscopic cholecystectomy
2. Patients diagnosed with symptomatic gallbladder stone diseases based on clinical evaluation and imaging studies
3.Patients who provide informed consent to participate in the study 
 
ExclusionCriteria 
Details  1. Patients requiring urgent or emergency surgery due to acute cholecystitis will be excluded from the study as they may have different surgical considerations and outcomes
2.Patients with a history of previous upper abdominal surgery that may significantly alter the surgical anatomy such as gastric bypass or liver resection
3. Patients with known or suspected biliary tract anomalies (e.g Mirizzi syndrome, anomalous biliary anatomy) or ductal pathology (e.g choledocholithiasis, strictures) identified preoperatively
4. Patients with contraindications to laparoscopic surgery such as severe cardiopulmonary disease, uncontrolled coagulopathy, or intra-abdominal adhesions precluding safe laparoscopic access
5. Pregnant females will be excluded due to potential risks to maternal and fetal health and limitations in imaging modalities
6. Patients underwent administration of immunosuppressive agents in the past month
7. Patients with cognitive impairment or inability to provide informed consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Rate and quality of achievement of the Critical View of Safety which will be defined according to Strasberg criteria of doublet photography
2.Duration of surgery 
Primary outcome will be assessed intraoperatively and post operatively after completion of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1.Comparison of intraoperative and postoperative complications
2.Recovery of gastrointestinal function (passing of first flatus)
3.Post-operative pain, nausea and vomiting
4.Length of hospital stay
5.Pre and post operative change in inflammatory marker 6.Patient satisfaction using SF 36 criteria 
All Patients will be followed in post operative period , at the time of discharge , 1 month and 3 months interval. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 4 
Date of First Enrollment (India)   05/11/2024 
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  

Gall stone disease is a major health problem affecting people all around the world. Evidences suggests that prevalence of gall stone diseases are on the rise. Gold standard treatment for symptomatic gall stone diseases is laparoscopic cholecystectomy. Critical view of safety is measured as a end point of Hepatocystic triangle dissection, which can be achieved by different methods of dissection. The present prospective randomized trial was undertaken to compare the efficacy of achievement of the Critical View of Safety and to analyse the operative time required for each technique.

The study will be conducted at the Department of General Surgery, All India Institute of Medical Sciences, Gorakhpur Uttar Pradesh India. This tertiary care centre is equipped with advanced medical facilities and a high volume of surgical cases, providing a suitable environment for conducting a randomized controlled trial. The setting ensures access to a diverse patient population undergoing elective Laparoscopic cholecystectomy, allowing for robust data collection and analysis. This study is a prospective, randomized, controlled, single-blinded, parallel assignment, single centre trial designed to compare the efficacy and safety of the body-first technique versus the conventional technique in achieving a critical view of safety during Laparoscopic cholecystectomy . A patient who will fulfill the inclusion criteria and does not satisfy any of the exclusion criteria will be randomized in to body first or conventional approach. The institution’s experienced surgical teams and state-of-the-art surgical suites will support the accurate assessment of both surgical techniques under study . CONSORT guidelines for randomized controlled trials will be followed. Outcome measures include the successful achievement of the Critical View of Safety which will be defined according to Strasberg criteria of doublet photography and Comparison of duration of surgery ,intraoperative and postoperative complications, recovery of gastrointestinal function , post-operative pain, nausea and vomiting, length of hospital stay, pre and post op change in inflammatory marker, patient satisfaction  between the two techniques.

 
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