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Transumbilical Versus Infraumbilical Pneumoperitoneum in Laparoscopic Cholecystectomy

2026年5月20日 更新者:Dr Mudassar Saeed Pansota

Transumbilical Versus Infraumbilical Pneumoperitoneum in Laparoscopic Cholecystectomy a Comparative Study

The case study is planned to emanate a comparison between transumbilical pneumoperitoneum and infraumbilical in patients that undergo laparoscopic cholecystectomy. It concentrates on the port access time, events during intraoperative access, postoperative change of events, pain, hospitalization, and cosmetic satisfaction. Through evaluation of both technical and patient centred outcomes, this study can help elucidate on whether transumbilical approach possesses practical benefits compared with its alternative, the conventional method of infraumbilical, without adding risk to the operations. These findings can justify other safer, more efficient and aesthetically correct primary port placement in laparoscopic cholecystectomy.

研究概览

详细说明

The recognized standard care surgical therapy of symptomatic case of gallstone disease is laparoscopic cholecystectomy due to the provision of smaller wounds, lesser postoperative pain, happen faster to mobilize, hospital stay, and speedy restoration to usual activity relative to open surgery. Although this has these benefits, the process does not go without morbidity. They may occur when dissecting the gallbladder, clipping, cystous structures, extracting the specimen or sewing wounds of trocar but one of the most severe scenarios occurs when entering the peritoneal cavity and the formation of pneumoperitoneum. This is performed before direct intraperitoneal visualization is fully matured and, due to this, is prone to the problems of access, such as bowel trauma, vascular trauma, inability to enter and extraperitoneal incontinence, loss of gases, subcutaneous emphysema, postoperative bleeding and associated wound morbidity.

Safety of pneumoperitoneum safe creation has been a key issue in laparoscopic surgery. Various methods such as the closed Veress needle, open Hassan, optical trocar insertion and direct trocar access have been performed with mixed outcomes. In laparoscopic cholecystectomy, the main entry point is most frequently located at or around the umbilicus due to the access point being central, the abdominal wall is isotomically thin and the location of the cosmetically acceptable scar is located. Nevertheless, the exact site of umbilical access varies among surgeons. Clinical practice with infraumbilical, supraumbilical, periumbilical, and transumbilical is common, mostly depending on the preferences of the surgeon, the body habitus of the patient or any surgical history, and common institutional routine.

Infraumbilical type has long been popular as the initial mode of port insertion as it is common, technically easy and well taught. It can however leave a visible scar beneath the umbilicus and can be correlated with port-site bleeding, infection, hematoma, seroma, pain and hernia. There is clinical significance in port-site morbidity as it may influence recovery, patient satisfaction, visits to the hospital, antibiotic usage, and quality of life in the long run.6 Most port-site complications are harmless, but trocar-site hernia deserves attention since it can manifest itself late and in some cases necessitate operative intervention. There is recent evidence that site of extraction of the specimen can also contribute to the risk of trocar-site hernia, particularly in cases where the umbilical port is extended during gallbladder removal.

Due to its ability to utilise the natural umbilical depression, the transumbilical approach has become of growing interest as the surgical scar can be hidden within the umbilicus. This can enhance the cosmetic satisfaction which is a well-known patient-centered outcome in minimally invasive surgery. Transumbilical could also offer an alternative path through the most flakey section of the anterior abdominal wall and may help to decrease the number of other apparent cuts. Recent prospective trials of transumbilical and single-incision laparoscopic cholecystectomy have documented positive cosmetic and acceptable safety, and possibly advantages of postoperative recovery when carried out on trained surgeons. Nonetheless, these benefits need to be offset against potential issues like crowding of instruments, wound infection, umbilical pain, and incisional hernia threat.

The evaluation of transumbilical versus infraumbilical pneumoperitoneum presently compared is thus applicable in the aspects of safety in surgery as also patient satisfaction. Although serious complications remain rare, even minor variations in access time, gas leakage, bleeding, postoperative pain, infection or scar satisfaction can be significant since laparoscopic cholecystectomy can and often is practiced worldwide. Existing literature has compared open and closed entry methods, single incision with the traditional laparoscopic cholecystectomy entry methods, and transumbilical incision and periumbilical access but there is limited evidence comparing transumbilical and infraumbilical access when applied to routine laparoscopic cholecystectomy procedures.2,4,8 Furthermore, the results can be variable as they depend on patient features in a local area, experience of the surgeon, emergency or elective operation, and perioperative procedures.

研究类型

介入性

注册 (实际的)

125

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Punjab Province
      • Rawalpindi、Punjab Province、巴基斯坦、60000
        • Pakistan Railway Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adult patients (≥18 years) undergoing laparoscopic cholecystectomy for symptomatic gallstone disease (biliary colic, cholecystitis, gallbladder polyps requiring surgery).
  • Both elective and emergency laparoscopic cholecystectomy cases.
  • Patients of both genders

Exclusion Criteria:

  • Patients with choledocholithiasis, obstructive jaundice, or dilated common bile duct requiring ERCP or alternative interventions.
  • Patients undergoing a planned open cholecystectomy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:Transumbilical pneumoperitoneum
In transumbilical group, umbilical cicatrix was incised and primary port was inserted by the use of the transumbilical route to create pneumoperitoneum.
安慰剂比较:Infraumbilical pneumoperitoneum
In the infraumbilical group, a skin incision was made just below the umbilicus, and the primary port was introduced through the infraumbilical route. Another routine surgical procedure at the study center was the creation of a pneumoperitoneum. Once pneumoperitoneum was created successfully, laparoscope was inserted and the rest of ports were done under direct vision as per the traditional laparoscopic cholecystectomy procedure

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
Percentage of complications
大体时间:day 1
bleeding, vessel injury, bowel injury
day 1

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月9日

初级完成 (实际的)

2026年5月8日

研究完成 (实际的)

2026年5月8日

研究注册日期

首次提交

2026年5月15日

首先提交符合 QC 标准的

2026年5月15日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月20日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • Pakistan Railways Hospital

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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