NCT01726231

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 25, 2013

Status Verified

December 1, 2013

Enrollment Period

1.1 years

First QC Date

November 9, 2012

Last Update Submit

December 24, 2013

Conditions

Other Surgical Procedures

Keywords

Laparoscopic accessAbdominal wall liftingDirect trocar insertionSafety endoscopy

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

the patiens undergoing laparoscopic surgery for various indications

You may qualify if:

  • the patients who performed laparoscopic surgery

You may not qualify if:

  • the patients who suspected pregnancy
  • large scale intrabdominal mass

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Study Officials

  • TANER A USTA, M.D.

    Bagcilar Training and Research Hospital, Istanbul, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2012

First Posted

November 14, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 25, 2013

Record last verified: 2013-12

Locations

TU(1)