An interventional study of Vertical Fascial Extension and Horizontal Fascial Extension in Cholelithiasis, Difficult Gallbladder Extraction and Laparoscopic Cholecystectomy Surgery, sponsored by Bangladesh Navy. Completed at 1 site in Bangladesh. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Bangladesh Navy · Not applicable, Interventional, and Treatment
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.
286 studies on the registry are indexed under Cholelithiasis; 48 are open to participants now.
This study's enrollment of 156 is above the median of 90 across 197 interventional studies indexed under Cholelithiasis.
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Exclusion Criteria:
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.
Procedure: Vertical Fascial Extension
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.
Procedure: Horizontal Fascial Extension
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.
Procedure: Tri-Radial Fascial Micro-Incision
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.
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 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.
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.
Time frame: 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.
Time frame: Intraoperative, during gallbladder specimen extraction
Fascial Extension Length
Total length of fascial extension required to complete difficult gallbladder extraction through the umbilical port site, measured in millimeters.
Time frame: Intraoperative, immediately after specimen extraction
Postoperative Pain Score
Postoperative pain at the umbilical port site measured using a visual analog scale, where 0 indicates no pain and 10 indicates worst imaginable pain.
Time frame: 24 hours after surgery
Analgesic Requirement
Number of doses of postoperative analgesic medication required during the first 24 hours after surgery.
Time frame: 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.
Time frame: Up to 30 days after surgery
Cystic Duct Clip Dislodgement
Occurrence of cystic duct clip displacement or dislodgement during gallbladder extraction.
Time frame: Intraoperative, during gallbladder specimen extraction
Port-Site Hernia
Occurrence of clinically detected or ultrasound-confirmed hernia at the umbilical extraction port site
Time frame: 12 months after surgery
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
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