Tri-Radial Port Extension for Difficult Gallbladder Extraction (NCT07595692) | Clinical Trial Compass
CompletedNot Applicable
Tri-Radial Port Extension for Difficult Gallbladder Extraction
Bangladesh156 participantsStarted 2024-01-22
Plain-language summary
Laparoscopic cholecystectomy is a common operation for gallbladder stones. In some patients, the removed gallbladder is difficult to extract through the umbilical port because it is large, thick-walled, or packed with stones. Surgeons commonly enlarge the fascial opening either vertically or horizontally to remove the specimen. These extensions may cause bleeding, tissue trauma, pain, and possible port-site complications.
This study compares three methods of enlarging the umbilical fascial opening during difficult gallbladder extraction: vertical fascial extension, horizontal fascial extension, and a new tri-radial fascial micro-incision technique called Tareq's Port Extension (TPE). In TPE, three small radial cuts are made around the fascial opening to create a controlled expansion and facilitate extraction.
The study aims to determine whether TPE reduces extraction difficulty, extraction-site bleeding, extraction time, postoperative pain, and port-site complications compared with conventional vertical and horizontal fascial extension techniques. Patients will also be followed for 12 months to assess port-site hernia.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients aged 18 to 70 years.
* Patients undergoing laparoscopic cholecystectomy for benign gallbladder disease.
* Intraoperatively confirmed difficult gallbladder extraction through the umbilical port site.
* Difficult extraction due to large gallbladder size, thickened gallbladder wall, large stone, multiple packed stones, or resistance at the fascial level.
* Patients willing to participate and provide written informed consent.
* Patients willing to attend follow-up for assessment of port-site complications and hernia.
Exclusion Criteria:
* Conversion to open cholecystectomy before gallbladder extraction.
* Suspected or confirmed gallbladder malignancy.
* Uncorrected coagulopathy.
* Pregnancy.
* Previous major midline abdominal surgery affecting the umbilical port site.
* Uncontrolled gallbladder perforation or major stone spillage before extraction.
* Refusal to provide informed consent.
* Inability or unwillingness to complete follow-up.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Extraction-Site Bleeding Severity
Timeframe: Intraoperative, during gallbladder specimen extraction
2
Specimen Extraction Time
Timeframe: Intraoperative, during gallbladder specimen extraction