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Safe and Easy Access Technique for the First Trocar in Laparoscopic Obesity Surgery

Safe and Easy Access Technique for the First Trocar in Laparoscopic Obesity Surgery. A Prospective Controlled-cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03015935
Enrollment
500
Registered
2017-01-10
Start date
2010-01-31
Completion date
2018-05-31
Last updated
2017-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid

Keywords

Obesity, Morbid

Brief summary

Laparoscopic surgery has become very popular and standard in many indications after advancements of technique. Various methods have been used in first entry to the abdomen. Safety, wound size, to be not time-consuming, low cost, learning curve and efficacy are important. Several techniques, instruments, and approaches to minimize the risk of injury (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have been introduced. There is no consensus yet on an optimal method has yet emerged. The investigators aimed to evaluate efficacy of entry methods that ensures safe insertion of the first trocar at any site of the abdomen. To evaluate the efficacy of entry technique, the investigators used cohort of patients who will be planned to laparoscopic obesity surgery. Two methods are commonly used in surgical literature and in our center. The investigators have been used visible optical-entry technique in some patients for first entry and Veress technique in some other patients. For this purpose, the investigators designed an observational study.

Detailed description

Several techniques, instruments, and approaches to minimize the risk of injury (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have been introduced. These methods include the standard technique of insufflation after insertion of the Veress needle, the open (Hasson technique), the direct trocar insertion and optical trocar insertion. Furthermore, it is more difficult to perform in the obese patient, especially if the first trocar is not umbilical, like obesity surgery. This is because obese patients have a very thick abdominal wall (particularly in women) as well as a thick peritoneum. Very different complications, some even potentially fatal, i.e., injury to viscera or to major intra-abdominal and abdominal wall vessels, have been reported in surgical literature. Complications of first entry develop in up to 1-2% of patients and more than half of all are fatal complications. Major vascular and abdominal organ injury rates of 0.03-0.1% and 0.08-0.14%, respectively, have been reported. Surprisingly, there has been little change in entry techniques since the dawn of laparoscopic surgery. Some risk factors are defined for prediction of complications, such as obesity. Laparoscopic obesity surgery has become very attractive and gaining popularity, recently, and however it possess many complications and challenges such as (it starts with) entry to the abdomen.

Interventions

PROCEDUREvisual-assisted entry

First trocar entry will be performed with visual-assisted trocar

PROCEDUREVeress entry

First trocar entry will be performed with Veress

Sponsors

Umraniye Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with body mass index of \>40

Exclusion criteria

* Patients who have skin disease at operation area

Design outcomes

Primary

MeasureTime frame
Entry timeintraoperative

Countries

Turkey (Türkiye)

Contacts

Primary ContactFatih Basak, MD
fatihbasak@gmail.com5055034571

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026