Tri-Radial Port Extension for Difficult Gallbladder Extraction

NCT07595692 | Completed

• 1 other identifier: BNSP-TPE-LC-2024-001
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholelithiasis; Difficult Gallbladder Extraction; Laparoscopic Cholecystectomy Surgery; Port-Site Fascial Extension

Keywords

Laparoscopic cholecystectomy; gallbladder extraction; Tri-radial fascial micro-incision; Tareq's Port Extension; port-site extension; fascial extension; port-site hernia; gallstone disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Fascial Extension Length

  Intraoperative, immediately after specimen extraction

• Postoperative Pain Score

  24 hours after surgery

• Analgesic Requirement

  Within 24 hours after surgery

• Port-Site Wound Complications

  Up to 30 days after surgery

• Cystic Duct Clip Dislodgement

  Intraoperative, during gallbladder specimen extraction

Study Arms (3)

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.

Procedure: Vertical Fascial Extension

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.

Procedure: Horizontal Fascial Extension

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.

Procedure: Tri-Radial Fascial Micro-Incision

Interventions

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.

Vertical Fascial Extension

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.

Horizontal Fascial Extension

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.

Tri-Radial Fascial Micro-Incision

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangladesh Navy: lead

Study Sites (1)

Bns Patenga

Dhaka, Chattogram, 4204, Bangladesh

Location

Related Publications (10)

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MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Head of the Dept of Surgery, BNS PATENGA Hospital, Bangladesh Navy

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 19, 2026
• Study Start: January 22, 2024
• Primary Completion: April 28, 2025
• Study Completion: April 27, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months after publication of the main study results and will remain available for 5 years.
• 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.

Locations

BA (1)