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IRCT20250616066203N1 IRCT 2025-07-04 Zahedan University of Medical Sciences ### General Title for Clinical Trial**Assessment of the Effectiveness of Drain Placement in Laparoscopic Cholecystectomy** Evaluation of the effectiveness of drain placement in laparoscopic cholecystectomy. 2025-07-22 anticipated 60 Complete https://irct.ir/trial/84385 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patient allocation will be conducted using permuted block stratified randomization. Initially, eligible patients will be classified based on age and gender in the order of their arrival. They will then be allocated to the desired groups based on random selection of 4-member blocks (comprising two groups A and B, each with two repetitions). These blocks have been created using the statistical software R version 4..2. 2 Acute Cholecystitis. Intervention 1: The intervention group consists of patients who will undergo cholecystectomy, and in this group, some patients will receive drains (for fluid drainage). The aim of this group is to assess the impact of the presence of drains on postoperative pain and associated complications, such as nausea and vomiting. Demographic information of these patients along with the details of the surgery will be recorded in specific forms and subsequently subjected to statistical analysis. Intervention 2: Control Group:In this study, the control group will consist of patients who have undergone cholecystectomy without drain placement. These patients will be matched with the intervention group (with drain) in terms of age, sex, body mass index (BMI), and surgical status (elective or emergency). The same inclusion and exclusion criteria (e.g., age 18–65 years, no pregnancy, and no history of psychiatric disorders) will be applied to both groups. Yes - There is a plan to make this available What will be shared: The final result will be provided in the format of the application form of the Research and Technology Deputy of the university for publication to the Knowledge Translation section of Zahedan University of Medical Sciences. When: It will be one year after the implementation of the project. To whom: University students and researchers Conditions: not applicable Where to obtain: Please refer to Dr. Sina Kiani Afzali at the surgery department of Ali Ibn Abi Talib Hospital in Zahedan. How to obtain: Please refer to Dr. Saman Kiani Afzali at the surgery department of Ali Ibn Abi Talib Hospital in Zahedan. Comments:
public Sina Kiani Afzali
University Campus of Medical Sciences.,Doctor Hesabi Square
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5570 dr.sina.kiani@zaums.ac.ir Zahedan University of Medical Sciences scientific Sina Kiani Afzali
University Campus of Medical Sciences,Doctor Hesabi Square
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5570 dr.sina.kiani@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Main inclusion criteria include patients who are candidates for drain placement during laparoscopic cholecystectomy. 18 years 80 years Both Main exclusion criterion includes conversion of laparoscopic surgery to open surgery. Acute chol K81.0 Treatment - Surgery Treatment - Surgery The intervention group consists of patients who will undergo cholecystectomy, and in this group, some patients will receive drains (for fluid drainage). The aim of this group is to assess the impact of the presence of drains on postoperative pain and associated complications, such as nausea and vomiting. Demographic information of these patients along with the details of the surgery will be recorded in specific forms and subsequently subjected to statistical analysis. Control Group:In this study, the control group will consist of patients who have undergone cholecystectomy without drain placement. These patients will be matched with the intervention group (with drain) in terms of age, sex, body mass index (BMI), and surgical status (elective or emergency). The same inclusion and exclusion criteria (e.g., age 18–65 years, no pregnancy, and no history of psychiatric disorders) will be applied to both groups. Pain. Timepoint: 12 hours and 24 hours after drainage placement. Method of measurement: Based on the VAS (Visual Analog Scale) criteria. Nausea and vomiting. Timepoint: Based on the VAS (Visual Analog Scale) criteria. Method of measurement: Based on the visual criteria. Zahedan University of Medical Sciences Approved 2025-05-11 Ethics Committee of Zahedan University of Medical Sciences medical Sciences Campus Zahedan,Dr. Hesabi Square Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)