A Comparison of Three Different Entry Points to Establish the Pneumoperitoneum

China-Japan Friendship Hospital

Status: Unknown

Conditions: Laparoscopic Entry Technique

Treatments: Device: Veress needle

Study type: Interventional

Funder types: Other

Identifiers

NCT02804529

ChinaJapanFH Meng001

Details and patient eligibility

About

The Palmer's point and periumbilical region are the common laparoscopic entry site to establish the pneumoperitoneum. In the present study, the investigators assess the safety and feasibility of Meng's point as a new laparoscopic entry site in cases to perform the gastrointestinal surgery.

This prospective and randomized study will compare the three entry techniques with regard to:

• Complications related to the entry technique
• Time taken to enter the abdomen.
• The number of attempts taken to enter the abdomen

Full description

Patients of China-Japan Friendship Hospital that are having a laparoscopic surgery for general surgery purposes will participate in the study. Patients with previous abdominal surgeries will be excluded from the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will be randomized into the three arms of the trial. All patient information will be confidential and only be available to researches involved in the study. Only one attending surgeon of the General Surgery Department of China-Japan Friendship Hospital will participate in the study. 90 patients will be recruited over one year period and the data will be analysed by a statistician.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient suitable for laparoscopic abdominal surgery

Exclusion criteria

• previous abdominal surgeries

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Meng's Point entry

Experimental group

Description:

Meng's entry involved a 0.2 cm horizontal or vertical incision using the Veress needle in the cross of lateral border of the left rectus abdominis and rib arch.

Treatment:

Device: Veress needle

Palmer's Point entry

Experimental group

Description:

Palmer's entry involved a 0.2 cm horizontal or vertical incision with the Veress needle in the left midclavicular line approximately 3 cm caudal to the 10th rib

Treatment:

Device: Veress needle

Periumbilllicus entry

Experimental group

Description:

Periumbilllicus entry involved a 0.2 cm horizontal or vertical midline incision using the Veress needle in the lower or uper border of the umbilicus.

Treatment:

Device: Veress needle