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Comparing two types of keyhole surgery for gallbladder removal: A clinical trial

Conventional versus two ports plus one puncture laparoscopic cholecystectomy: A clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN50339464
Enrollment
98
Registered
2024-09-11
Start date
2019-12-01
Completion date
Unknown
Last updated
2024-10-28

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

Conditions

Two ports plus one puncture laparoscopic cholecystectomy is as safe and effective as conventional laparoscopic cholecystectomy. Surgery

Interventions

This is a hospital-based, interventional, randomized controlled study that was carried out over a period of 21 months in a surgical unit at No. (1) Military Hospital (700 bedded) in Pyin Oo Lwin, Myan

Sponsors

Defence Services Medical Academy
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients with symptomatic gall stones with ASA I & II

Exclusion criteria

Exclusion criteria: 1. Patients with ASA III, IV & V 2. Previous upper abdominal surgery 3. Patients with common bile duct pathology 4. Patients with clinical or USG suspected gall bladder cancer 5. Patients with bleeding disorders

Design outcomes

Secondary

MeasureTime frame
There are no secondary outcome measures

Primary

MeasureTime frame
Measured using patient records unless noted otherwise: 1. The operation time is noted from the time of skin incision to the last stitch of skin closure. 2. Intraoperative complications including bile duct injury, bowel injury, vascular injury, and injuries to nearby structures are observed in all cases during operation. 3. Postoperative pain is measured using a visual analogue scale (VAS) within 12 hour, 24 hour, 36 hour and 48 hour. 4. Rescue analgesia is added with injection of intravenous tramadol 1mg/kg if VAS is more than 4 and/or if the patient suffers breakthrough pain or if the patient complains of pain between the assessments. 5. Postoperative complications like prolonged ileus and wound infection in all cases are observed daily during the hospital stay. 6. The duration of a hospital stay is measured from the time it takes from the date of surgery to the date of discharge based on the discharge criteria.

Countries

Myanmar

Contacts

Public ContactMin Nay Zar Wyke
minnayzarwyke3681@gmail.com+95 95501867

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026