| CTRI Number |
CTRI/2026/01/100581 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study of Two Methods of Closing the Bile Duct in Laparoscopic Gallbladder Surgery |
|
Scientific Title of Study
|
A Comparative Study on Harmonic Scalpel Assisted Cystic Duct Ligation with Absorbable Suture Versus Clip Ligation of Cystic Duct in Conventional Laparoscopic Cholecystectomy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
UTKARSH SUNIL LANGADE |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DATTA MEGHE MEDICAL COLLEGE |
| Address |
Datta Meghe Medical College (DMMC), Datta Meghe Institute of Higher Education & Research (DMIHER), Nagpur, Maharashtra, India
Datta Meghe Medical College (DMMC), Datta Meghe Institute of Higher Education & Research (DMIHER), Nagpur, Maharashtra, India
Nagpur
MAHARASHTRA
431010
India |
| Phone |
9922328042 |
| Fax |
|
| Email |
utkarshsl1708@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAJIV SONARKAR |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
DATTA MEGHE MEDICAL COLLEGE |
| Address |
Datta Meghe Medical College (DMMC), Datta Meghe Institute of Higher Education & Research (DMIHER), Nagpur, Maharashtra, India
Datta Meghe Medical College (DMMC), Datta Meghe Institute of Higher Education & Research (DMIHER), Nagpur, Maharashtra, India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9922328042 |
| Fax |
|
| Email |
rsonarkar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
UTKARSH SUNIL LANGADE |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DATTA MEGHE MEDICAL COLLEGE |
| Address |
Datta Meghe Medical College (DMMC), Datta Meghe Institute of Higher Education & Research (DMIHER), Nagpur, Maharashtra, India
Datta Meghe Medical College (DMMC), Datta Meghe Institute of Higher Education & Research (DMIHER), Nagpur, Maharashtra, India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9922328042 |
| Fax |
|
| Email |
utkarshsl1708@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
UTKARSH SUNIL LANGADE |
| Address |
Datta Meghe Medical College (DMMC), Datta Meghe Institute of Higher Education & Research (DMIHER), Nagpur, Maharashtra, India |
| Type of Sponsor |
Other [PRINCIPAL INVESTIGATOR] |
|
|
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 |
| UTKARSH SUNIL LANGADE |
SHALINITAI MEGHE HOSPITAL AND RESEARCH CENTRE |
Department of General Surgery
Nagpur
MAHARASHTRA |
9922328042
utkarshsl1708@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE, DATTA MEGHE MEDICAL COLLEGE, NAGPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CYSTIC DUCT LIGATION WITH CLIPS IN LAPAROSOCPIC CHOLECYSTECTOMY |
Dissection of Calots triangle performed using a hook electrocautery. The cystic duct and artery are secured with titanium clips and divided. The gallbladder is then dissected from its hepatic bed using electrocautery. |
| Intervention |
HARMONIC SCALPEL ASSISTED CYSTIC DUCT LIGATION WITH ABSORBABLE SUTURE |
Dissection and hemostasis are performed using the Harmonic scalpel. The cystic artery and duct are sealed and divided using harmonic energy, followed by ligation of the cystic duct with absorbable sutures (e.g., 2-0 Vicryl) using the Loop method(Roeder’s Knot). The power setting is adjusted (level 2 for coagulation and level 5 for cutting) as needed.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18–80 years
Diagnosis of gallbladder stones confirmed by radiological investigations.
Symptomatic Cholelithiasis
Resolved Acute Cholecystitis
Post ERCP (for Choledocholithiasis) patients.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean operative time (in minutes) required for laparoscopic cholecystectomy in harmonic scalpel–assisted absorbable suture ligation versus conventional clip ligation. |
Expected mean operative time with clips = 60 min (SD = 10 min)
Expected mean with harmonic scalpel = 54 min
Effect size = 6 min
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
10/01/2026 |
| 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
|
This study is a prospective, randomized, single-centre, comparative clinical trial comparing the safety and efficacy of harmonic scalpel-assisted cystic duct ligation using absorbable sutures versus conventional clip ligation of the cystic duct in patients undergoing elective laparoscopic cholecystectomy. The study will be conducted over a period of 2 years at a tertiary care teaching hospital in Central India and will include 88 adult patients with symptomatic gallstone disease, randomized equally into two groups. The primary outcome measures will be intraoperative safety and efficacy, assessed by operative time, intraoperative complications, and incidence of postoperative bile leakage. The secondary outcome measures will include cost analysis, postoperative pain scores, duration of hospital stay, and long-term complications such as clip migration or chronic inflammatory sequelae, assessed during a follow-up period of six months.
|