Cholelithiasis, Difficult Gallbladder Extraction, Laparoscopic Cholecystectomy Surgery, Port-Site Fascial Extension
Conditions
Keywords
Laparoscopic cholecystectomy, gallbladder extraction, Tri-radial fascial micro-incision, Tareq's Port Extension, port-site extension, fascial extension, port-site hernia, gallstone disease
Brief 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.
Detailed description
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.
Interventions
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.
Sponsors
Study design
Intervention model description
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.
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extraction-Site Bleeding Severity | Intraoperative, during gallbladder specimen extraction | 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. |
| Specimen Extraction Time | Intraoperative, during gallbladder specimen extraction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fascial Extension Length | Intraoperative, immediately after specimen extraction | Total length of fascial extension required to complete difficult gallbladder extraction through the umbilical port site, measured in millimeters. |
| Postoperative Pain Score | 24 hours after surgery | Postoperative pain at the umbilical port site measured using a visual analog scale, where 0 indicates no pain and 10 indicates worst imaginable pain. |
| Analgesic Requirement | Within 24 hours after surgery | Number of doses of postoperative analgesic medication required during the first 24 hours after surgery. |
| Port-Site Wound Complications | Up to 30 days after surgery | Occurrence of port-site wound complications including surgical site infection, seroma, hematoma, or wound discharge at the umbilical extraction site. |
| Cystic Duct Clip Dislodgement | Intraoperative, during gallbladder specimen extraction | Occurrence of cystic duct clip displacement or dislodgement during gallbladder extraction. |
| Port-Site Hernia | 12 months after surgery | Occurrence of clinically detected or ultrasound-confirmed hernia at the umbilical extraction port site |
Countries
Bangladesh