Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion

Other Surgical Procedures Clinical Trial

Official title:

Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726231
• Other study ID #: BEH GynObs-2
• Status: Completed
• Phase: N/A
• First received: November 9, 2012
• Last updated: December 24, 2013
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Bagcilar Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

In laparoscopy, over %50 of the all complications occur during establishment of the pneumoperitoneum. Lifting of the anterior abdominal wall is aimed to increase the distance between the abdominal wall and the intrabdominal structures. Elevation of the anterior abdominal wall is recommended for the access to peritoneal cavity in literatures however the benefit exactly has not proved. This study aimed to determine the distance from anterior abdominal wall to intraperitoneal structures during lifting of the abdominal wall, to represent this distance -on the average- generate the safe range whether or not and compare with this distance and patient's age, BMI and parity.

Description:

40 patients who undergoing laparoscopic surgery for various indications are enrolled in the study. The telescope is inserted at second trocar place and the distances between anterior abdominal wall and visceral organs are measured with plastic hysterometry during maximal elevation of the abdominal wall.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• the patients who performed laparoscopic surgery

Exclusion Criteria:

• the patients who suspected pregnancy

• large scale intrabdominal mass

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Other Surgical Procedures

Locations

Country	Name	City	State
Turkey	Bagcilar Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure of this study is to determine the distance in centimeters from anterior abdominal wall to intraperitoneal visceral structures during lifting of the abdominal wall with plastic hysterometry.		2-3 months	No