An interventional study of Endobag and placebo group in Cholecystectomy, Laparoscopic and Cholelithiasis, sponsored by Rawal Institute of Health Sciences Islamabad. Recruiting at 1 site in Pakistan. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Rawal Institute of Health Sciences Islamabad · Not applicable, Interventional, and Treatment
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.
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.
189 studies on the registry are indexed under Cholelithiasis; 42 are open to participants now.
This study's planned enrollment of 120 is above the median of 90 across 135 interventional studies indexed under Cholelithiasis.
Browse Cholelithiasis studies →This is the only study on the registry with Rawal Institute of Health Sciences Islamabad as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Endobag
Device: placebo group
Gallbladder will be removed using Endobag
Gallbladder will be removed without using Endobag during Laparoscopic Cholecystectomy
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
Plan to share: No — Ethical committee doesnt allow data sharing
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