Rawal Institute of Health Sciences
Islamabad, Federal, 44000, Pakistan
Location status: Recruiting
Location contact
Mirza
CONTACT
Mirza Inam Ul Haq, MBBS,MPH,MBA,PhD,PGD-HPE,MHPE
CONTACT
Recruiting
NCT Number: NCT07823803
Improvised Endobag vs Direct Gallbladder Extraction in Laparoscopic Cholecystectomy
Eligigble patients will be enrolled after obtaining informed consent. Basic information such as age, gender, body weight, smoking and alcohol history, number of gallstones, and gallbladder characteristics will be recorded.
During surgery, the method used to remove the gallbladder, the port used for extraction, and the duration of surgery will be documented. Any gallbladder perforation, leakage of bile, or spillage of gallstones during the procedure will also be recorded.
After surgery, patients will be monitored in the hospital for 24 hours. Their pain will be assessed before discharge. Patients will then be followed in the outpatient clinic for 10 days to assess wound healing and identify any wound infection or other complications.
The study aims to compare the safety and effectiveness of an improvised retrieval bag with removal of the gallbladder without a retrieval bag during laparoscopic surgery.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
20 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Eligible patients undergoing laparoscopic cholecystectomy will be enrolled after obtaining written informed consent. Baseline demographic and clinical characteristics, including age, gender, body mass index, smoking and alcohol history, hypertension, number of gallstones, and gallbladder wall thickness, will be recorded.
Patients will be randomly allocated to receive one of the predefined gallbladder extraction techniques. The port site used for gallbladder retrieval and total operative time will be documented. Intraoperative events, including gallbladder perforation, bile spillage, and stone spillage, will be recorded according to predefined operational definitions.
All procedures will be performed under general anesthesia by the same surgical team. Wound closure will be performed by the researcher using a standardized technique to minimize procedural variability and potential bias.
Following surgery, patients will be monitored in the postoperative ward for 24 hours. Postoperative pain will be assessed using a standardized pain score before discharge. Patients will subsequently be followed in the outpatient department for 10 days, during which the surgical wound will be assessed for infection and other relevant postoperative complications.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Elective Laparoscopic Cholecystectomy
Exclusion criteria
- Patients having common bile duct stones or dilatation
- Acute cholecystitis, gallbladder perforation, malignancy (on medical record).
- Patients requiring conversion to open cholecystectomy, ASA III-IV
- Patients with skin diseases near wound site, diabetes (HbA1c>6.5%), and Hb <10gm/dl
Treatment and study plan
Endobag
DeviceGallbladder will be removed using Endobag
Placebo Group
DeviceGallbladder will be removed without using Endobag during Laparoscopic Cholecystectomy
Primary outcomes
-
Surgical Time
Time frame: This will be the time in minutes measured Peri-procedurally from skin incision to skin closure
-
Visible perforation of the gallbladder developed during gallbladder removal
Time frame: Perioperative/Periprocedural
-
Visible spillage of bile from the gallbladder during gallbladder removal
Time frame: Perioperative/Periprocedural (at the time of gallbladder removal)
-
Visible spillage of gallstones from the gallbladder during gallbladder removal
Time frame: Perioperative/Periprocedural
-
Port site pain
Time frame: It will be assessed using Visual Analog scale at 24 hours post procedure
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Rawal Institute of Health Sciences Islamabad
Other
Registry information
Official study title
Retrieval of Gallbladder by Improvised Endobag Versus Direct Extraction in Laparoscopic Cholecystectomy
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Sep 16, 2026
- Registry last updated
- Sep 16, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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