Study for assessment of change in symptoms and quality of life following cholecystectomy (Gall bladder removal surgery)

Not yet recruiting

• Conditions: Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,

• Registration Number: CTRI/2019/03/017958
• Lead Sponsor: Department of Surgical Disciplines

Brief Summary

Minimally invasive cholecystectomy (which includes Laparoscopic / Robotic Cholecystectomy) is emerging as one of the most commonly performed elective surgical procedures performed worldwide.

However, the audit of symptom improvement and emergence of newer symptoms post minimally invasive cholecystectomy is lacking in the literature.

Further, the literature of impact of minimally invasive cholecystectomy on Quality of Life especially for patients with atypical symptoms and asymptomatic Gall stones is scant.

Hence, we wish to undertake this study to perform an audit of symptom improvement and emergence of newer symptoms and Quality of Life post minimally invasive cholecystectomy.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-03-03
• Study Start: 2019-10-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• a) Patients with cholelithiasis undergoing minimally invasive cholecystectomy.
• b) Age greater than or equal to 18 years.

Exclusion Criteria

• a)Patients suspected or diagnosed case of carcinoma gall bladder.
• b)Patients undergoing cholecystectomy along with other surgery(for instance hernia repair in same sitting).
• c) Patients undergoing open cholecystectomy.
• d) Patients deemed unfit for General Anaesthesia.
• e) Patients not giving consent.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief of pre-operative symptoms and change in the quality of life after minimally invasive cholecystectomy.	Pre-operative and then Follow up at around 01 week, 03 months and 6 months after surgery.

Secondary Outcome Measures

Name	Time	Method
Persistence and/or emergence of new symptoms following minimally invasive cholecystectomy.	Follow up at around 01 week, 03 months and 6 months after surgery.

Trial Locations

Locations (1)

ALL INDIA INSTITUTE OF MEDICAL SCIENCES (AIIMS), New Delhi, Department of surgical disciplines; 🇮🇳 Delhi, DELHI, India

ALL INDIA INSTITUTE OF MEDICAL SCIENCES (AIIMS), New Delhi, Department of surgical disciplines

🇮🇳Delhi, DELHI, India

Dr Toshib G A

Principal investigator

9818226267

toshibga@gmail.com