Comparative study of laproscopic and open cholecystectomy for symptomatic gall stone disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1- Comparison of operative time, postoperative pain, and complications
研究概览
简要总结
“Comparative Study of Laparoscopic and Open Cholecystectomy for Symptomatic Gall Stone Disease”
Submitted by: Dr. Kanishka Patel
Course: MS General Surgery (2023–2026)
Institution: Varun Arjun Medical College & Rohilkhand Hospital, Shahjahanpur, UP
- Introduction:
Cholecystectomy is the standard treatment for symptomatic gallstones. Laparoscopic cholecystectomy (LC) has largely replaced open cholecystectomy (OC) due to advantages like:
Smaller incisions
Less postoperative pain
Shorter hospital stays
Faster recovery
However, safety concerns in complex cases still persist. This study compares both methods to guide surgical decision-making.
- Review of Literature:
Operative Time: Initially longer for LC but now comparable as surgical experience has grown.
Hospital Stay & Recovery: LC results in significantly shorter stays and quicker return to normal activities.
Pain: Postoperative pain is consistently lower with LC.
Complications: OC and LC have comparable complication rates. LC had more bile duct injuries early on, now reduced.
Cost-Effectiveness: Though LC is costlier initially, it is more cost-effective long term.
Patient Satisfaction: Higher with LC due to faster recovery and better cosmetic results.
Recent Advances: SILS and robotic-assisted surgeries show promise for even better outcomes.
- Aim & Objectives:
Aim:
To compare outcomes of laparoscopic vs. open cholecystectomy in symptomatic gallstone disease.
Objectives:
-
Compare operative time
-
Compare postoperative pain
-
Evaluate hospital stay
-
Compare complications
-
Assess patient satisfaction
-
Analyze cost-effectiveness
-
Materials and Methods:
Study Type: Prospective, comparative study
Duration: 1 year
Setting: Varun Arjun Medical College & Rohilkhand Hospital
Sample Size: 60 patients (30 LC, 30 OC)
Inclusion: Adults (18–75 years) with symptomatic gallstones, ASA I/II
Exclusion: Complicated gallstones, prior abdominal surgeries, severe comorbidities, pregnancy
Randomization: Computer-generated or sealed envelope technique
Surgical Technique:
LC: 4-port technique
OC: Right subcostal incision
Data Collection Parameters:
Demographics: Age, sex, BMI, comorbidities
Operative data: Operative time, intra-op complications, conversion rates
Postoperative data: Pain score (VAS), complications, hospital stay, recovery, scar assessment
Follow-up: 1 week, 1 month, 3 months
Statistical Tests: Chi-square, Fisher’s exact, t-test (Significance: p < 0.05)
- Ethical Considerations:
Approval from the Institutional Ethics Committee
Informed consent in English & Hindi
Patient confidentiality maintained
Participation voluntary, with no effect on standard care
Risks and benefits explained
No insurance coverage; institutional care in case of complications
- Consent Form Highlights:
Explained in native language
Participant can withdraw anytime
Consent for use of anonymous data in publications
Details regarding duration, benefits, risks, and confidentiality provide
- Study Proforma Includes:
Personal details
History (complaints, medical/surgical/family/social)
Examination (general, abdominal)
Investigations (CBC, LFT, USG, etc.)
Diagnosis
Treatment & follow-up plan
- Gantt Chart:
(To be submitted as per institutional format showing proposed timeline)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Day(s) 至 75.00 Day(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with symptomatic gallstone disease (e.g., biliary colic, cholecystitis).
- •Age range: 18-75 years.
- •Both genders included.
- •Patients fit for general anesthesia (ASA I or II).
排除标准
- •Patients with complicated gallstone disease (e.g., cholangitis, pancreatitis).
- •Previous upper abdominal surgery leading to adhesions.
- •Patients with contraindications for laparoscopy (e.g., uncontrolled coagulopathy, severe cardiopulmonary diseases).
- •Pregnant women.
结局指标
主要结局
1- Comparison of operative time, postoperative pain, and complications
时间窗: 1 year
次要结局
- Comparison of hospital stay, recovery time, and cost-effectiveness.
研究者
Dr PS Powar
Varun arjun medical College and hospital