Tri-Radial Port Extension for Difficult Gallbladder Extraction (TPE-LC)

Tri-Radial Fascial Micro-Incision Technique for Difficult Gallbladder Extraction During Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Cholelithiasis; Laparoscopic Cholecystectomy Surgery; Difficult Gallbladder Extraction; Port-Site Fascial Extension
• Intervention / Treatment: Procedure: Vertical Fascial Extension; Procedure: Horizontal Fascial Extension; Procedure: Tri-Radial Fascial Micro-Incision

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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Chattogram
    • Dhaka, Chattogram, Bangladesh, 4204
      • Bns Patenga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vertical Fascial Extension; 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; 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.
Active Comparator: Horizontal 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; 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.
Experimental: Tri-Radial Fascial Micro-Incision; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bangladesh Navy

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Actual): April 28, 2025
• Study Completion (Actual): April 27, 2026

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Laparoscopic cholecystectomy; gallstone disease; gallbladder extraction; Tri-radial fascial micro-incision; Tareq's Port Extension; port-site extension; fascial extension; port-site hernia
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Cholelithiasis
• Other Study ID Numbers: BNSP-TPE-LC-2024-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the main study results and will remain available for 5 years.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No