Comparison of laparoscopic procedures with and without the aid the AutoLap system - a Robotic Camera Holder

Completed

• Conditions: coloncarcinoma/adenoma; diverticulosis/diverticulitis; gastroesophageal reflux disease; Hiatal hernia; 10017943; 10017991; 10017998

• Registration Number: NL-OMON43195
• Lead Sponsor: Medical Surgery Technologies ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1) Aged * 18 years
2) Able to provide a written informed consent
3) Fit for standard laparoscopic general surgery

Exclusion Criteria

1) Pregnancy
2) Contra-indications for laparoscopy
3) Obesity (BMI >35 Kg/m2)
4) Patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The success rate, in terms of the ability to successfully complete an elective<br /><br>general laparoscopic procedure, with one less person in the OR compared with<br /><br>the number of OR personnel used in routine laparoscopic procedures. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Duration of the operation, defined as the time from the first abdominal<br /><br>incision until the surgical procedure is completed<br /><br>(skin incisions are closed)<br /><br>Number of times that the laparoscope was removed for cleaning<br /><br>Baseline characteristics: age, sex, BMI, ASA score, comorbidities, surgical<br /><br>procedure and indication<br /><br>Surgical characteristics: date of surgery, type of surgery, surgeon,<br /><br>intra-operative complications<br /><br>Length of stay in the hospital, complications during hospitalization</p><br>