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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Chattogram
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Dhaka, Chattogram, Bangladesh, 4204
- Bns Patenga
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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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.
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Comparador activo: 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.
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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.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Extraction-Site Bleeding Severity
Periodo de tiempo: Intraoperative, during gallbladder specimen extraction
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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.
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Intraoperative, during gallbladder specimen extraction
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Specimen Extraction Time
Periodo de tiempo: Intraoperative, during gallbladder specimen extraction
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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.
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Intraoperative, during gallbladder specimen extraction
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fascial Extension Length
Periodo de tiempo: Intraoperative, immediately after specimen extraction
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Total length of fascial extension required to complete difficult gallbladder extraction through the umbilical port site, measured in millimeters.
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Intraoperative, immediately after specimen extraction
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Postoperative Pain Score
Periodo de tiempo: 24 hours after surgery
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Postoperative pain at the umbilical port site measured using a visual analog scale, where 0 indicates no pain and 10 indicates worst imaginable pain.
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24 hours after surgery
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Analgesic Requirement
Periodo de tiempo: Within 24 hours after surgery
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Number of doses of postoperative analgesic medication required during the first 24 hours after surgery.
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Within 24 hours after surgery
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Port-Site Wound Complications
Periodo de tiempo: Up to 30 days after surgery
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Occurrence of port-site wound complications including surgical site infection, seroma, hematoma, or wound discharge at the umbilical extraction site.
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Up to 30 days after surgery
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Cystic Duct Clip Dislodgement
Periodo de tiempo: Intraoperative, during gallbladder specimen extraction
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Occurrence of cystic duct clip displacement or dislodgement during gallbladder extraction.
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Intraoperative, during gallbladder specimen extraction
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Port-Site Hernia
Periodo de tiempo: 12 months after surgery
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Occurrence of clinically detected or ultrasound-confirmed hernia at the umbilical extraction port site
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12 months after surgery
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BNSP-TPE-LC-2024-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
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