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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.
This is a prospective, randomized, three-arm interventional study conducted at BNS PATENGA Hospital, Bangladesh Navy. The study evaluates a tri-radial fascial micro-incision technique for difficult gallbladder extraction during laparoscopic cholecystectomy.
During laparoscopic cholecystectomy, the gallbladder is usually removed through a 10 mm umbilical port. In some cases, extraction becomes difficult because of a large gallbladder, thick gallbladder wall, large stone, or multiple packed stones. When the gallbladder cannot pass smoothly through the port, surgeons often enlarge the fascial opening. Conventional methods include vertical or horizontal fascial extension. However, these techniques may be associated with bleeding, irregular tissue tearing, increased pain, and port-site complications.
The intervention being studied is the Tri-Radial Fascial Micro-Incision Technique, also designated as Tareq's Port Extension (TPE). In this technique, instead of extending the fascial opening in one linear direction, three small radial micro-incisions are made around the existing umbilical fascial defect. These small cuts are placed approximately at the 12, 4, and 8 o'clock positions and are kept within the linea alba. The purpose is to create a controlled cloverleaf-shaped expansion of the fascial opening, allowing easier gallbladder extraction while minimizing tissue trauma.
Participants with intraoperatively confirmed difficult gallbladder extraction are randomized into one of three groups:
Vertical fascial extension Horizontal fascial extension Tri-radial fascial micro-incision technique / Tareq's Port Extension
The primary outcomes are extraction time and extraction-site bleeding severity, categorized as minimal, moderate, or profuse. Secondary outcomes include fascial extension length, postoperative pain score, analgesic requirement, port-site infection, hematoma, seroma, clip dislodgement, and port-site hernia at 12 months.
The study is designed to assess whether TPE provides a safer, faster, and more controlled method of gallbladder extraction compared with conventional fascial extension techniques. The technique does not require any special device or additional costly equipment and may be useful in routine laparoscopic surgical practice, especially in settings where commercial specimen retrieval systems are not consistently available or reliable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vertical Fascial Extension | Active Comparator | Participants assigned to this arm undergo conventional vertical extension of the umbilical fascial opening when gallbladder extraction is difficult during laparoscopic cholecystectomy. The fascial opening is extended vertically in the midline as required to facilitate specimen extraction. |
|
| Horizontal Fascial Extension | Active Comparator | Participants assigned to this arm undergo conventional horizontal extension of the umbilical fascial opening when gallbladder extraction is difficult during laparoscopic cholecystectomy. The fascial opening is extended transversely as required to facilitate specimen extraction. |
|
| Tri-Radial Fascial Micro-Incision | Experimental | Participants assigned to this arm undergo the tri-radial fascial micro-incision technique, also designated Tareq's Port Extension. Three small radial fascial micro-incisions are made around the umbilical fascial opening to create controlled expansion and facilitate difficult gallbladder extraction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vertical Fascial Extension | Procedure | Conventional vertical extension of the umbilical fascial opening during difficult gallbladder extraction in laparoscopic cholecystectomy. The fascial defect is extended vertically in the midline as required to allow extraction of a large or stone-filled gallbladder specimen. |
| Measure | Description | Time Frame |
|---|---|---|
| Extraction-Site Bleeding Severity | Severity of bleeding from the umbilical fascial extraction site during difficult gallbladder extraction. Bleeding will be categorized as minimal, moderate, or profuse. Minimal bleeding is defined as no active bleeding or minor oozing controlled with simple pressure or brief cautery. Moderate bleeding is defined as bleeding requiring additional hemostatic intervention but not causing major operative interruption. Profuse bleeding is defined as brisk bleeding requiring prolonged hemostatic effort, suturing, or significant interruption of specimen extraction. | Intraoperative, during gallbladder specimen extraction |
| Specimen Extraction Time | Time required to extract the gallbladder specimen after confirmation of difficult extraction and initiation of fascial extension technique. Time will be measured in minutes from the start of fascial extension to complete removal of the gallbladder specimen through the umbilical port site. | Intraoperative, during gallbladder specimen extraction |
| Measure | Description | Time Frame |
|---|---|---|
| Fascial Extension Length | Total length of fascial extension required to complete difficult gallbladder extraction through the umbilical port site, measured in millimeters. | Intraoperative, immediately after specimen extraction |
| Postoperative Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bns Patenga | Dhaka | Chattogram | 4204 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15273542 | Background | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. | |
| 20332511 | Background | Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available. |
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De-identified individual participant data underlying the reported results may be shared upon reasonable request after publication of the main study results. Data will include demographic variables, operative findings, allocated intervention, primary outcome measures, secondary outcome measures, and follow-up data relevant to port-site complications and hernia. No directly identifiable patient information will be shared.
Data will be available beginning 6 months after publication of the main study results and will remain available for 5 years.
Data may be shared with qualified researchers who submit a scientifically sound proposal for secondary analysis, systematic review, meta-analysis, or validation of the study findings. Requests will be reviewed by the principal investigator and the institutional authority of BNS PATENGA Hospital. Data sharing will require institutional approval, a signed data use agreement, and assurance that the data will be used only for approved academic or scientific purposes.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2026 | May 8, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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Participants with intraoperatively confirmed difficult gallbladder extraction during laparoscopic cholecystectomy are randomized in a 1:1:1 ratio into three parallel intervention arms: vertical fascial extension, horizontal fascial extension, and tri-radial fascial micro-incision technique/Tareq's Port Extension. Outcomes are compared among the three groups.
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| Horizontal Fascial Extension | Procedure | Conventional horizontal extension of the umbilical fascial opening during difficult gallbladder extraction in laparoscopic cholecystectomy. The fascial defect is extended transversely as required to facilitate removal of a large or stone-filled gallbladder specimen. |
|
| Tri-Radial Fascial Micro-Incision | Procedure | Tri-radial fascial micro-incision technique used during difficult gallbladder extraction in laparoscopic cholecystectomy. Three small radial fascial micro-incisions are made around the umbilical fascial opening, approximately at the 12, 4, and 8 o'clock positions, to create controlled expansion and facilitate specimen extraction. |
|
Postoperative pain at the umbilical port site measured using a visual analog scale, where 0 indicates no pain and 10 indicates worst imaginable pain. |
| 24 hours after surgery |
| Analgesic Requirement | Number of doses of postoperative analgesic medication required during the first 24 hours after surgery. | Within 24 hours after surgery |
| Port-Site Wound Complications | Occurrence of port-site wound complications including surgical site infection, seroma, hematoma, or wound discharge at the umbilical extraction site. | Up to 30 days after surgery |
| Cystic Duct Clip Dislodgement | Occurrence of cystic duct clip displacement or dislodgement during gallbladder extraction. | Intraoperative, during gallbladder specimen extraction |
| Port-Site Hernia | Occurrence of clinically detected or ultrasound-confirmed hernia at the umbilical extraction port site | 12 months after surgery |
| 21686296 | Background | Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. Open Med. 2010;4(1):e60-8. Epub 2010 Mar 24. No abstract available. |
| 21672662 | Background | Owens M, Barry M, Janjua AZ, Winter DC. A systematic review of laparoscopic port site hernias in gastrointestinal surgery. Surgeon. 2011 Aug;9(4):218-24. doi: 10.1016/j.surge.2011.01.003. Epub 2011 Feb 1. |
| 22213083 | Background | Swank HA, Mulder IM, la Chapelle CF, Reitsma JB, Lange JF, Bemelman WA. Systematic review of trocar-site hernia. Br J Surg. 2012 Mar;99(3):315-23. doi: 10.1002/bjs.7836. Epub 2011 Dec 30. |
| 27177957 | Background | Comajuncosas J, Hermoso J, Jimeno J, Gris P, Orbeal R, Cruz A, Pares D. Effect of bag extraction to prevent wound infection on umbilical port site wound on elective laparoscopic cholecystectomy: a prospective randomised clinical trial. Surg Endosc. 2017 Jan;31(1):249-254. doi: 10.1007/s00464-016-4965-z. Epub 2016 May 13. |
| 30453917 | Background | La Regina D, Mongelli F, Cafarotti S, Saporito A, Ceppi M, Di Giuseppe M, Ferrario di Tor Vajana A. Use of retrieval bag in the prevention of wound infection in elective laparoscopic cholecystectomy: is it evidence-based? A meta-analysis. BMC Surg. 2018 Nov 19;18(1):102. doi: 10.1186/s12893-018-0442-z. |
| 27643488 | Background | Majid MH, Meshkat B, Kohar H, El Masry S. Specimen retrieval during elective laparoscopic cholecystectomy: is it safe not to use a retrieval bag? BMC Surg. 2016 Sep 19;16(1):64. doi: 10.1186/s12893-016-0181-y. |
| 1826143 | Background | Southern Surgeons Club. A prospective analysis of 1518 laparoscopic cholecystectomies. N Engl J Med. 1991 Apr 18;324(16):1073-8. doi: 10.1056/NEJM199104183241601. |
| 8000648 | Background | Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995 Jan;180(1):101-25. No abstract available. |