| 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
|
|
|
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
|
|
|
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
|
|
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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. |