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Comparison of Gallbladder Extraction Via Subxiphoid vs Infraumbilical Port in Laparoscopic Cholecystectomy

23. juni 2026 opdateret af: King Edward Medical University

Comparison of Gallbladder Extraction Via the Subxiphoid Port and the Infraumbilical Port During Laparoscopic Cholecystectomy: A Prospective Randomized Clinical Trial

Laparoscopic cholecystectomy is the standard surgical treatment for symptomatic gallstone disease due to its advantages in reducing postoperative pain and recovery times. However, surgeons continue to debate the optimal port site for retrieving the gallbladder specimen from the abdominal cavity, as this choice can influence wound-related morbidity.

Traditionally, the gallbladder is extracted through the infraumbilical port site. While effective, this route is associated with a potential risk of port-site infections due to bacterial colonization within the umbilicus and risk of contamination during specimen extraction. Retrieving the gallbladder through the subxiphoid port has been proposed as an alternative technique that may utilize a cleaner surgical site, potentially reducing patient pain scores and regional wound complications.

This prospective randomized clinical trial aims to directly compare the clinical outcomes of extracting the gallbladder through the subxiphoid port versus the traditional infraumbilical port. The study will evaluate and compare mean postoperative pain intensity within the first 24 hours, as well as the regional development of port-site infections, seromas, or hematomas within 7 days following elective laparoscopic surgery.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is structured as a parallel-group randomized controlled trial conducted at Mayo Hospital, Lahore, to evaluate the optimal retrieval site for specimen extraction during elective laparoscopic cholecystectomy.

Eligible patients aged 18 to 60 years diagnosed with symptomatic gallstone disease who meet all predefined inclusion criteria will be invited to participate. All surgical procedures will be standardized and performed under general anesthesia by a senior consultant surgeon using a conventional four-port technique. Following the successful mobilization of the gallbladder, the specimen will be enclosed safely inside a sterile endo-bag to control potential bile contamination.

Patients will then be dynamically allocated via a computer-generated randomization system into one of two surgical groups:

  • Group A (Experimental Arm): The endo-bag containing the gallbladder is carefully retrieved through the subxiphoid port site under direct vision.
  • Group B (Active Comparator Arm): The endo-bag containing the gallbladder is retrieved through the primary infraumbilical camera port site under direct vision.

Postoperatively, all participating patients will be systematically tracked for primary and secondary outcomes. Postoperative physical distress will be quantified while the patient is at rest using a 10-point Visual Analogue Scale (VAS) at regular intervals of 6, 12, and 24 hours. Additionally, specialized clinical assessments will be performed through the first 7 postoperative days to monitor and log the occurrence of port-site infections, staged using the Southampton Wound Classification system, alongside local complications including seroma or hematoma formation.

Statistical analyses will be executed using SPSS, utilizing independent t-tests for quantitative variables and Chi-square testing for qualitative categorical outcomes to evaluate significance.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

66

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Rekruttering
        • Department of Surgery ,Mayo Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Muhammad Zeeshan Sarwar, MBBS,FCPS

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

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Patients aged between 18 to 60 years.
  • Diagnosed with symptomatic gallstones on ultrasonography.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Scheduled for elective laparoscopic cholecystectomy.
  • Presence of acute or empyematous cholecystitis

Exclusion Criteria:

  • Intraoperative conversion to open cholecystectomy.
  • Diagnosed with Diabetes mellitus type 2.

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group A: Subxiphoid Port Extraction
Patients undergoing standard four-port laparoscopic cholecystectomy where the gallbladder specimen is placed in a sterile endo-bag and extracted through the subxiphoid port site under direct vision to minimize bile spillage.
Procedure: Subxiphoid Gallbladder Retrieval
Following standard four-port laparoscopic cholecystectomy, the cystic duct and artery are clipped and divided. The gallbladder specimen is then placed within a sterile endo-bag and extracted through the subxiphoid port site under direct laparoscopic visualization to minimize bile spillage and abdominal wall contamination.
Aktiv komparator: Group B: Infraumbilical Port Extraction
Patients undergoing standard four-port laparoscopic cholecystectomy where the gallbladder specimen is placed in a sterile endo-bag and extracted through the primary infraumbilical (camera) port site under direct vision.
Procedure: Infraumbilical Gallbladder Extraction
Following standard four-port laparoscopic cholecystectomy, the cystic duct and artery are clipped and divided. The gallbladder specimen is then placed within a sterile endo-bag and extracted through the primary camera port site at the infraumbilical incision under direct laparoscopic visualization.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Postoperative Pain Score
Tidsramme: At 6, 12, and 24 hours post-surgery
Postoperative pain intensity will be assessed while the patient is at rest using a 10-point Visual Analogue Scale (VAS), where 0 represents "No Pain" and 10 represents "Worst Possible Pain".
At 6, 12, and 24 hours post-surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Port-Site Infection
Tidsramme: Up to 7 postoperative days
The presence and severity of port-site infections will be evaluated and graded according to the objective criteria of the Southampton Wound Classification System (Grades 0 to V)
Up to 7 postoperative days
Incidence of Local Wound-Related Complications
Tidsramme: Up to 7 postoperative days
The development of local wound site complications, specifically tracking the presence or absence of a clinically or ultrasonographically confirmed seroma (clear fluid collection) or hematoma (localized blood collection).
Up to 7 postoperative days

Samarbejdspartnere og efterforskere

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

Sponsor

King Edward Medical University

Efterforskere

  • Ledende efterforsker: Dr Muhammad Zeeshan Sarwar, MBBS,FCPS, King Edward Medical University

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)

20. maj 2026

Primær færdiggørelse (Anslået)

15. juli 2026

Studieafslutning (Anslået)

15. august 2026

Datoer for studieregistrering

Først indsendt

15. juni 2026

Først indsendt, der opfyldte QC-kriterier

23. juni 2026

Først opslået (Faktiske)

26. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Dr Abdur Rehman

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared outside of the primary research team to maintain strict patient confidentiality, as mandated by the Institutional Review Board (IRB) and the Advanced Studies & Research Board (ASRB) of King Edward Medical University, Lahore. According to the signed institutional data protection affidavit and the informed patient consent protocol, all collected clinical data are strictly restricted for use within this specific postgraduate master's thesis project.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Kolecystitis, akut

Kliniske forsøg med Subxiphoid Gallbladder Retrieval

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