The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections (right hemicolectomy, left hemicolectomy/sigmoid resection), anti-reflux/hiatal hernia…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The success rate, in terms of the ability to successfully complete an elective
general laparoscopic procedure, with one less person in the OR compared with
the number of OR personnel used in routine laparoscopic procedures.
Secondary outcome
Duration of the operation, defined as the time from the first abdominal
incision until the surgical procedure is completed
(skin incisions are closed)
Number of times that the laparoscope was removed for cleaning
Baseline characteristics: age, sex, BMI, ASA score, comorbidities, surgical
procedure and indication
Surgical characteristics: date of surgery, type of surgery, surgeon,
intra-operative complications
Length of stay in the hospital, complications during hospitalization
Background summary
Laparoscopic surgery has become the preferred method for performing many
general surgery procedures. The popularity of laparoscopic surgery is mainly
because of the advantages that it offers to the patient in terms of shorter
hospital stay, shorter recovery time, improvements in cosmetic outcome, and
decreased postoperative complications. Standard laparoscopic procedures are
often performed by teams consisting of two or three surgeons and a surgical
nurse. Increasing cost pressure within the health system has raised the need
for manpower saving in the OR by using robotic systems.
Robotic active camera holders which have been developed provide steady camera
movements and view during the procedure and may replace the assistant holding
the camera. The AutoLap system, an image guided robotic active camera holder,
enables the surgeon to fully control the laparoscopic camera movements during
surgery using a small button which is affixed to his hand or the surgical tool,
and subsequently direct the surgical view with less erroneous camera motions,
providing steady camera movement and view during the laparoscopic surgery.
Additionally, the use of the AutoLap system may reduce the amount of personnel
needed in the operating room during surgery thus sparing valuable highly skilled
personnel for other tasks.
Study objective
The objective of this study is to evaluate the ability to reduce the number of
OR personnel required while performing the following procedures: colon
resections (right hemicolectomy, left hemicolectomy/sigmoid resection),
anti-reflux/hiatal hernia surgery with the AutoLap system compared with the
standard operation.
Study design
Prospective, randomized controlled single center study, open label
Intervention
NA
Study burden and risks
Minimal / theoretical: damage to internal organs due to unexpected or rude
movements of the endoscope and infection.
Kochav Yokneam POB 685
Yokneam 2069208
IL
Kochav Yokneam POB 685
Yokneam 2069208
IL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56735.100.16 |