Hernia, InguinalRobust _1NCT02975401
Robotic Utility for Surgical Treatment of Groin Hernias
An observational study of Hernia, Inguinal, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial summary
The purpose of this study is the measurement of the evolution of the operation time during the start-up phase of robotic-assisted surgery for the treatment of inguinal hernia's of 50 patients treated in Maria Middelares in laparoscopic rTAPP technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- rTAPP technique
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2016to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All eligible patients who are scheduled for laparoscopic repair of a unilateral or bilateral inguinal hernia. A total of 50 patients will be enrolled in this observational study.
Who may be able to join
- 50 patients selected and operated by the PI.
Who cannot join
- patients under the age of 18
- pregnancy
- BMI > 35
- recurrent groin hernia
- no Informed Consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Cohort Study on Robot-assisted Laparoscopic Hernia Repair (rTAPP)
The purpose of this study is the measurement of the evolution of the operation time during the start-up phase of robotic-assisted surgery for the treatment of inguinal hernia's of 50 patients treated in Maria Middelares in laparoscopic rTAPP technique.
Read the detailed description
Minimally invasive hernia repair by laparoscopy is the standard treatment in adult patients in Maria Middelares, Ghent. A previously conducted study demonstrated that the symptoms of patients with inguinal hernias (verified via EuraHS Quality of Life score) can be effectively treated and the technique has a low recurrence rate and low frequency of long-term side effects.
Robot-assisted laparoscopic surgery has become standard in urology for resection of the prostate carcinoma. In general abdominal surgery, a large group of surgeons are currently working on the introduction of robotic-assisted surgery for resection of colon and rectal cancer in their daily practice. The third generation robot (DaVinci Xi), has extended the applicability of this technology within the field of general surgery.
For the surgical treatment of hernia's and other abdominal wall defects (umbilical or/and incisional hernia's), currently only surgeons in the US have experiences in structured treatment programs.
From September 1, 2016 Maria Middelares hospital will introduce robot-assisted surgery, including the laparoscopic TAPP inguinal hernia repair.
Main obstacles to the introduction of robot technology in abdominal wall surgery are prolonged preparation time in the operating room required for installation of the robot, and higher material costs related to the robot-assisted surgery. However, there are few precise data available on the exact size of extra time or increased costs related to the introduction of robotic assisted surgery in a program for abdominal surgery.
The purpose of this study is the measurement of the evolution of the operation time during the start-up phase of robotic-assisted surgery for the treatment of inguinal hernias by 50 patients in Maria Middelares hospital.
- Conditions
- Hernia, Inguinal
- Being tested
- rTAPP technique
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTAPP techniqueProcedure or surgery
Also called laparoscopic robot-assisted TAPP technique
robot-assisted rTAPP technique
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of the operation
Recording of the operation time needed for robot-assisted TAPP groin hernia repair
Measured: from the start of the operation until the end of the operation, approximately 3 hours
Secondary outcomes (3)
intra-operative complications
Intra-operative complications registered until 4 weeks post-operative
Measured: until 4 weeks post-operative
post-operative complications
Post-operative complications detected until 4 weeks after hernia repair by clinical follow up.
Measured: until 4 weeks post-operative
Quality of Life
Quality of Life measured with the EuraHS QoL score preoperative and until 4 weeks after hernia repair by clinical follow up.
Measured: until 4 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Muysoms, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Filip Muysoms, MD, PhD, Principal investigator, Maria Middelares hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975401
- Sponsor's protocol ID
- Robust_1
- Acronym
- Robust _1
- Status last verified
- Jul 2017
- First submitted
- 24 Oct 2016
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Muysoms F, Van Cleven S, Kyle-Leinhase I, Ballecer C, Ramaswamy A. Robotic-assisted laparoscopic groin hernia repair: observational case-control study on the operative time during the learning curve. Surg Endosc. 2018 Dec;32(12):4850-4859. doi: 10.1007/s00464-018-6236-7. Epub 2018 May 15.
PubMed 29766308
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Cohort Study on Robot-assisted Laparoscopic Hernia Repair (rTAPP)
- ClinicalTrials.gov ID
- NCT02975401
- Acronym / sponsor ID
- Robust _1 / Robust_1
- Conditions
- Hernia, Inguinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is the measurement of the evolution of the operation time during the start-up phase of robotic-assisted surgery for the treatment of inguinal hernia's of 50 patients treated in Maria Middelares in laparoscopic rTAPP technique.
Detailed description
Minimally invasive hernia repair by laparoscopy is the standard treatment in adult patients in Maria Middelares, Ghent. A previously conducted study demonstrated that the symptoms of patients with inguinal hernias (verified via EuraHS Quality of Life score) can be effectively treated and the technique has a low recurrence rate and low frequency of long-term side effects.
Robot-assisted laparoscopic surgery has become standard in urology for resection of the prostate carcinoma. In general abdominal surgery, a large group of surgeons are currently working on the introduction of robotic-assisted surgery for resection of colon and rectal cancer in their daily practice. The third generation robot (DaVinci Xi), has extended the applicability of this technology within the field of general surgery.
For the surgical treatment of hernia's and other abdominal wall defects (umbilical or/and incisional hernia's), currently only surgeons in the US have experiences in structured treatment programs.
From September 1, 2016 Maria Middelares hospital will introduce robot-assisted surgery, including the laparoscopic TAPP inguinal hernia repair.
Main obstacles to the introduction of robot technology in abdominal wall surgery are prolonged preparation time in the operating room required for installation of the robot, and higher material costs related to the robot-assisted surgery. However, there are few precise data available on the exact size of extra time or increased costs related to the introduction of robotic assisted surgery in a program for abdominal surgery.
The purpose of this study is the measurement of the evolution of the operation time during the start-up phase of robotic-assisted surgery for the treatment of inguinal hernias by 50 patients in Maria Middelares hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All eligible patients who are scheduled for laparoscopic repair of a unilateral or bilateral inguinal hernia. A total of 50 patients will be enrolled in this observational study.
Key inclusion criteria (1 listed)
- 50 patients selected and operated by the PI.
Key exclusion criteria (5 listed)
- patients under the age of 18
- pregnancy
- BMI > 35
- recurrent groin hernia
- no Informed Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTAPP techniqueAlso: laparoscopic robot-assisted TAPP techniquerobot-assisted rTAPP technique | Procedure or surgery | – |
Primary outcome
duration of the operation
Time frame: from the start of the operation until the end of the operation, approximately 3 hours
Recording of the operation time needed for robot-assisted TAPP groin hernia repair
3 secondary outcomes
intra-operative complications
Time frame: until 4 weeks post-operative
post-operative complications
Time frame: until 4 weeks post-operative
Quality of Life
Time frame: until 4 weeks post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Derived from this study: PubMed 29766308Muysoms F, Van Cleven S, Kyle-Leinhase I, Ballecer C, Ramaswamy A. Robotic-assisted laparoscopic groin hernia repair: observational case-control study on the operative time during the learning curve. Surg Endosc. 2018 Dec;32(12):4850-4859. doi: 10.1007/s00464-018-6236-7. Epub 2018 May 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Muysoms, MD, PhD principal investigator
Maria Middelares hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Inguinal, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of the operation (time frame: from the start of the operation until the end of the operation, approximately 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02975401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.