A Comparison of Three Different Entry Points to Establish the Pneumoperitoneum

Not Applicable

• Conditions: Laparoscopic Entry Technique
• Interventions: Device: Veress needle

• Registration Number: NCT02804529
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-17
• Study Start: 2016-07
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-08
• Last Update Posted: 2018-02-09
• Primary Completion: 2018-06
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Any patient suitable for laparoscopic abdominal surgery

Exclusion Criteria

• previous abdominal surgeries

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periumbilllicus entry	Veress needle	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.
Meng's Point entry	Veress needle	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.
Palmer's Point entry	Veress needle	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

Primary Outcome Measures

Name	Time	Method
Complications during entry in laparoscopy	During surgery

Secondary Outcome Measures

Name	Time	Method
Time to enter in the abdominal cavity	During surgery

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China