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Study to compare Quality Of Life After Single Stage Vs Two Stage treatment Of Patients With Gall Stones And Common Bile Duct Stones

Comparison Of Quality Of Life After Single Stage Vs Two Stage Management Of Patients With Concomitant Gall Stones And Common Bile Duct Stones: A Prospective Randomized Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/014276
Enrollment
53
Registered
2018-05-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- ASA 1/2 pateints with concomitant gall stones and CBD stones

Interventions

Intervention1: Endoscopic Stone Extraction followed by Laparoscopic Cholecystectomy: Bile duct stones will be removed by ERCP first and then laparoscopic cholecystectomy will be performed. Control Int

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with symptomatic gall stone disease with choledocholithiasis 2. Patients with dilated common bile duct.

Exclusion criteria

Exclusion criteria: 1. Patients who do not give consent for participation in the study. 2. Patients with previous hepatobiliary surgery. 3. Patients with morbid obesity. 4. Patients with uncorrectable coagulopathy. 5. Patients unfit for GA. 6. Patients who have undergone previous endoscopic papillotomy / sphincterotomy. 7. Patients with significant comorbid conditions

Design outcomes

Primary

MeasureTime frame
Assessment of quality of life via EORTC QLQ C-30, WHO BREF and HADS questionnairesTimepoint: Preoperatively and 3 months post operatively—

Secondary

MeasureTime frame
Success Rate, Complications, Cost of procedures, Pain scores, Operative time, Hospital stay, Ease of Cholecystectomy, Follow upTimepoint: All patients will be followed up at 1 week, 6 weeks, 3 months and 6 months to one year or if they develop symptoms at any time—

Countries

India

Contacts

Public ContactVirinder Kumar Bansal

All India Institute of Medical Sciences, New Delhi, India

sunitasuman.aiims@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026