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.
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Chattogram
-
Dhaka、Chattogram、孟加拉国、4204
- Bns Patenga
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器: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.
|
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.
|
|
有源比较器: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.
|
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.
|
|
实验性的: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.
|
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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Extraction-Site Bleeding Severity
大体时间: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
大体时间: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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fascial Extension Length
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:Intraoperative, during gallbladder specimen extraction
|
Occurrence of cystic duct clip displacement or dislodgement during gallbladder extraction.
|
Intraoperative, during gallbladder specimen extraction
|
|
Port-Site Hernia
大体时间:12 months after surgery
|
Occurrence of clinically detected or ultrasound-confirmed hernia at the umbilical extraction port site
|
12 months after surgery
|
合作者和调查者
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- BNSP-TPE-LC-2024-001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.