Health Condition 1: K801- Calculus of gallbladder with othercholecystitis
Conditions
Interventions
Intervention1: TRUTIE Ligating clips: Trutie ligating clips are used for ligation of tubular structure or vessels where a non-absorbable ligating clip is indicated. Once applied will not be removed fr
Sponsors
Healthium Medtech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female patients aged between 18 to 60 years 2. Subjects scheduled for elective laparoscopic cholecystectomy surgery 3. Subjects willing to give written informed consent and willing to comply with all study requirements
Exclusion criteria
Exclusion criteria: 1. Subjects with history of pancreatitis 2. Subjects with suspicion of gallbladder carcinoma or other metastatic diseases 3. Subjects who are pregnant or lactating at the time of surgery 4. Subjects with coagulation disorder 5. Subjects intraoperatively found to have with modified Nassar difficulty grading scale 3 4 and 5 6. Subjects whose surgical approach got converted from laparoscopic to open surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the incidence of bile leakage and bleeding after closure of cystic duct and cystic artery in both groupsTimepoint: Day of surgery, Day of discharge, Day 10 post surgery, Day 30 post surgery, Day 180 post surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of intra and post operative complications adverse device reactions and adverse events from day of surgery to 6 months post operativelyTimepoint: Day of surgery Day of discharge Day 10 post surgery Day 30 post surgery Day 180 post surgery;Assessment of intraoperative handling of clips between the two groups using 5 point scale and Assessment of number of clip breakage failure to ligate and malformed or deformed clipsTimepoint: Day of surgery;Number of clips used to ligate cystic duct and arteryTimepoint: Day of surgery;Postoperative length of hospital stay in both the groupsTimepoint: Day of discharge;Time taken from initial incision to closure of wound Timepoint: Day of surgery;To assess the incidence of residual risks of ligating clipsTimepoint: Day of surgery Day of discharge Day 10 post surgery Day 30 post surgery Day 180 post surgery;To assess the time to recovery as measured by return to the normal day to day activitiesTimepoint: Day 10 post surgery Day 30 post surgery Day 180 post surgery;To evaluate the quality of life using the Otago gallstones condition specific questionnaireTimepoint: Baseline visit Day 30 post surgery Day 180 post surgery | — |
Countries
India
Contacts
Public ContactDr Ashok Kumar Moharana
Healthium Medtech Limited
Outcome results
None listed