Assessment of the efficacy of drain placement in laparoscopic cholecystectomy.
Design
A randomized controlled trial, phase 2, will use permuted block stratified randomization for the allocation of 60 participants.
Settings and conduct
This study investigates the complications following laparoscopic cholecystectomy and the impact of drain usage in patients. The aim of this research is to enhance awareness regarding the potential outcomes of drain usage and its relation to patients' quality of life. The trial will be conducted at Imam Ali Hospital in Zahedan, where 60 patients meeting specific criteria will be randomly allocated into intervention and control groups using stratified block randomization. Demographic information and post-operative complications will be recorded in relevant forms and subsequently analyzed using SPSS software.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
All patients diagnosed with cholecystitis, whether elective or urgent, provided personal and informed consent.
Exclusion Criteria
Pregnant women, lack of personal consent from patients, any history of psychiatric disorders, age under 18 and over 65 years, having a BMI greater than 30, and having a BMI less than 19.
Intervention groups
The intervention group consists of patients who will have therapeutic drains placed during laparoscopic cholecystectomy. The aim of this procedure is to evaluate the impact of using drains on postoperative complications, including pain levels, nausea, vomiting, and the duration of recovery.
Control Group
The control group consists of patients who will not have any drains placed during laparoscopic cholecystectomy. The objective of this group is to compare postoperative complications with the intervention group.
Main outcome variables
Pain after drain placement
Duration of the surgery
Type of surgical procedure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250616066203N1
Registration date:2025-07-04, 1404/04/13
Registration timing:prospective
Last update:2025-07-04, 1404/04/13
Update count:0
Registration date
2025-07-04, 1404/04/13
Registrant information
Name
Sina Kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5770
Email address
dr.sina.kiani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-22, 1404/04/31
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of drain placement in laparoscopic cholecystectomy.
Public title
### General Title for Clinical Trial**Assessment of the Effectiveness of Drain Placement in Laparoscopic Cholecystectomy**
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Main inclusion criteria include patients who are candidates for drain placement during laparoscopic cholecystectomy.
Exclusion criteria:
Main exclusion criterion includes conversion of laparoscopic surgery to open surgery.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
medical Sciences Campus Zahedan,Dr. Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2025-05-11, 1404/02/21
Ethics committee reference number
IR.ZAUMS.REC.1404.057
Health conditions studied
1
Description of health condition studied
Acute Cholecystitis
ICD-10 code
Acute chol
ICD-10 code description
K81.0
Primary outcomes
1
Description
Pain
Timepoint
12 hours and 24 hours after drainage placement
Method of measurement
Based on the VAS (Visual Analog Scale) criteria
2
Description
Nausea and vomiting
Timepoint
Based on the VAS (Visual Analog Scale) criteria
Method of measurement
Based on the visual criteria
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Surgery
2
Description
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.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Talib Hospital, Zahedan
Full name of responsible person
Sina
Street address
Persian Gulf Boulevard, Surgery Department,Ali Ibn Abi Talib Hospital,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5564
Email
dr.sina.kiani@zaums.ac.ir
Web page address
https://alihos.zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Ansari Moghaddam
Street address
Vice Chancellor for Research and Technology, University of Zahedan,Medical Sciences Campus,Persian Gulf Boulevard
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2117
Email
nfo@zaums.ac.ir
Web page address
https://research.zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sina Kiani Afzali
Position
Specialized Surgical Assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
University Campus of Medical Sciences.,Doctor Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5570
Email
dr.sina.kiani@zaums.ac.ir
Web page address
https://zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sina Kiani Afzali
Position
Specialized Surgical Assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
University Campus of Medical Sciences,Doctor Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5570
Email
dr.sina.kiani@zaums.ac.ir
Web page address
https://zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sina Kiani Afzali
Position
Specialized Surgical Assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
University Campus of Medical Sciences,Doctor Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5570
Email
dr.sina.kiani@zaums.ac.ir
Web page address
https://zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
It will be one year after the implementation of the project.
To whom data/document is available
University students and researchers
Under which criteria data/document could be used
not applicable
From where data/document is obtainable
Please refer to Dr. Sina Kiani Afzali at the surgery department of Ali Ibn Abi Talib Hospital in Zahedan.
What processes are involved for a request to access data/document
Please refer to Dr. Saman Kiani Afzali at the surgery department of Ali Ibn Abi Talib Hospital in Zahedan.