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

15. maj 2026 opdateret af: Mohammad Tarequl Islam, Bangladesh Navy

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

156

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Aktiv komparator: 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.
Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Extraction-Site Bleeding Severity
Tidsramme: 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.
Intraoperative, during gallbladder specimen extraction
Specimen Extraction Time
Tidsramme: 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.
Intraoperative, during gallbladder specimen extraction

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fascial Extension Length
Tidsramme: Intraoperative, immediately after specimen extraction
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
Tidsramme: 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.
24 hours after surgery
Analgesic Requirement
Tidsramme: Within 24 hours after surgery
Number of doses of postoperative analgesic medication required during the first 24 hours after surgery.
Within 24 hours after surgery
Port-Site Wound Complications
Tidsramme: 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.
Up to 30 days after surgery
Cystic Duct Clip Dislodgement
Tidsramme: Intraoperative, during gallbladder specimen extraction
Occurrence of cystic duct clip displacement or dislodgement during gallbladder extraction.
Intraoperative, during gallbladder specimen extraction
Port-Site Hernia
Tidsramme: 12 months after surgery
Occurrence of clinically detected or ultrasound-confirmed hernia at the umbilical extraction port site
12 months after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bangladesh Navy

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. januar 2024

Primær færdiggørelse (Faktiske)

28. april 2025

Studieafslutning (Faktiske)

27. april 2026

Datoer for studieregistrering

Først indsendt

8. maj 2026

Først indsendt, der opfyldte QC-kriterier

15. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BNSP-TPE-LC-2024-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

Data will be available beginning 6 months after publication of the main study results and will remain available for 5 years.

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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