Tri-Radial Fascial Micro-Incision Technique for Difficult Gallbladder Extraction During Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Mohammad Tarequl Islam
Principal Investigator; Head of the Dept of Surgery, BNS PATENGA Hospital, Bangladesh Navy
Bangladesh Navy