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

2026년 5월 15일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

156

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 방글라데시
    • Chattogram
      • Dhaka, Chattogram, 방글라데시, 4204
        • Bns Patenga

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
절차: 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.
활성 비교기: 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.
절차: 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.
실험적: 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.
절차: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Extraction-Site Bleeding Severity
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Fascial Extension Length
기간: 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
기간: 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
기간: 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
기간: 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
기간: Intraoperative, during gallbladder specimen extraction
Occurrence of cystic duct clip displacement or dislodgement during gallbladder extraction.
Intraoperative, during gallbladder specimen extraction
Port-Site Hernia
기간: 12 months after surgery
Occurrence of clinically detected or ultrasound-confirmed hernia at the umbilical extraction port site
12 months after surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Bangladesh Navy

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 1월 22일

기본 완료 (실제)

2025년 4월 28일

연구 완료 (실제)

2026년 4월 27일

연구 등록 날짜

최초 제출

2026년 5월 8일

QC 기준을 충족하는 최초 제출

2026년 5월 15일

처음 게시됨 (실제)

2026년 5월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 15일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BNSP-TPE-LC-2024-001

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Vertical Fascial Extension에 대한 임상 시험

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약물 개입

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스폰서 / 협력자

위치

구독하다