Morbid ObesityNCT01760512
Clinical and Health Economic Impact of Robot-assisted Surgery vs Conventional Laparoscopy : the Case of Gastric Bypass
A study testing Gastric bypass in people with Morbid Obesity, run by IHU Strasbourg at 1 site in France.
Trial summary
The purpose of this study is to gather clinical and economic evidence on the use of robotics for bariatric surgery (gastric bypass). This monocentric, randomized, single blind, controlled study will evaluate post-operative pain, quality of life and appetite, post-operative complication incidence. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Jun 2015
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient presenting with major obesity (BMI ≥ 35) with co-morbidities or morbid obesity (BMI ≥ 40)according to French HAS (Haute Autorité de Santé) and CNAMTS (Caisse nationale de l'assurance maladie des travailleurs salariés)criteria for whom gastric bypass is scheduled
- Male or female between 18 and 65 years old
- Patient registered with the French Social Security
- Patient having provided a written informed consent prior to enrolment
- Patient accepting to attend follow-up visits as required by study protocol
Who cannot join
- Patient with a BMI ≥ 60
- Patient with a contraindication for laparoscopic gastric bypass with or without robotic assistance
- Patient having had prior bariatric surgery
- Patient having had prior major abdominal surgery
- Patient in exclusion period of another clinical study
- Patient pregnant or breastfeeding
- Patient without sufficient knowledge of french language or unable to receive or understand study related information and answer to questionnaires
- Patient with no or limited legal capacity
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Digestive et Endocrinienne
Strasbourg, 67 000
About this study
Official title: Prospective, Single-blind, Randomized, Non-inferiority, and Controlled Study of Clinical and Health Economic Impact of Robot-assisted Surgery Versus Conventional Laparoscopy in Bariatric Surgery: the Case of Gastric Bypass
The purpose of this study is to gather clinical and economic evidence on the use of robotics for bariatric surgery (gastric bypass).
This monocentric, randomized, single blind, controlled study will evaluate post-operative pain, quality of life and appetite, post-operative complication incidence. It will also provide information on direct and indirect costs of surgery.
Read the detailed description
Robot-assisted Surgery Versus Conventional Laparoscopy in Bariatric Surgery (Gastric Bypass): a prospective, single-blind, randomized, non-inferiority, and controlled study The main evaluation criterion is 24h post-operative pain assessed using visual analog scale (VAS). Secondary criteria included for clinical assessment: post 24h pain, excess weight loss, quality of life, appetite, complications, conversion rate; and for health-economics assessment : duration of surgical steps, length of stay, return to normal activity and their conversion to cost, consumables, estimation of indirect costs and benefits (e.g., robotics perception, publication).
In this study, main inclusion criteria include major obesity (IMC ≥ 35) with co-morbidities or morbid obesity (IMC ≥ 40), scheduled gastric bypass surgery Main contraindications are previous bariatric surgery and previous major abdominal surgeries To test robotic-assisted surgery non-inferiority on VAS pain score 24h post-surgery, a total of 128 patients (64 per arm) is to be included (alpha 2,5%; power 90%; drop-out rate: 5%).
The study will include 12 months of follow-up post-surgery for each patient. The total study duration is 2 years and 3 months.
- Conditions
- Morbid Obesity
- Being tested
- Gastric bypass
- Keywords
- Gastric bypass, Robot-assisted surgery, Conventional laparoscopy, Pain assessment, Health economics outcomes
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypassProcedure or surgery
Gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted surgery | Experimental | Robot-assisted (da Vinci surgical system) gastric bypass Receives: Procedure: Gastric bypass |
| Conventional laparoscopy | Active comparator | Laparoscopic gastric bypass Receives: Procedure: Gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
24h postoperative pain
Pain assessment 24h post surgery (visual analog scale)
Measured: 24h
Secondary outcomes (10)
Evaluation of post-operative pain
Evaluation of post-operative pain (beyond 24h post-operative) using VAS
Measured: 24h, 8 days, 1, 3, 6 and 12 months
Evaluation of quality of life (BAROS and GIQLI)
Evaluation of quality of life using BAROS and GIQLI questionaires
Measured: At 1, 3, 6 and 12 months
Evaluation of appetite level
Evaluation of appetite level using VAS
Measured: At 8 days, 1, 3, 6 and 12 months
Percentage of excess weight loss
Measure of excess weight loss - % from baseline
Measured: At 8 days, 1, 3, 6 and 12 months
Conversion rate to conventional laparoscopy
Conversion rate to conventional laparoscopy (only applicable to robot-assisted surgery arm)
Measured: During the procedure (Day 0)
Nature of per-operative complications
Nature of per-operative complications
Measured: During the procedure (Day 0)
Nature of post-operative complications
Nature of post-operative complications
Measured: Following the procedure (Day 0) up to 12 months
Evaluation of operative times
Evaluation of key steps of gastric bypass surgery, OR occupation time
Measured: During the procedure (Day 0)
Evaluation of direct costs
Direct costs include material used, OR occupation time, length of stay, return to normal activity
Measured: During the procedure (day 0) and up to 12 months
Evaluation of indirect costs
Combination of number of patients having surgery, perception of robot-assisted surgery by both personnel and patients, publications, and communications
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Vix, Principal investigator, Service de Chirurgie Générale et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760512
- Sponsor's protocol ID
- 12-002
- Status last verified
- May 2015
- First submitted
- 10 Dec 2012
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-blind, Randomized, Non-inferiority, and Controlled Study of Clinical and Health Economic Impact of Robot-assisted Surgery Versus Conventional Laparoscopy in Bariatric Surgery: the Case of Gastric Bypass
- ClinicalTrials.gov ID
- NCT01760512
- Acronym / sponsor ID
- 12-002
- Conditions
- Morbid Obesity
- Keywords
- Gastric bypass, Robot-assisted surgery, Conventional laparoscopy, Pain assessment, Health economics outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Jan 2013 (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 to gather clinical and economic evidence on the use of robotics for bariatric surgery (gastric bypass).
This monocentric, randomized, single blind, controlled study will evaluate post-operative pain, quality of life and appetite, post-operative complication incidence. It will also provide information on direct and indirect costs of surgery.
Detailed description
Robot-assisted Surgery Versus Conventional Laparoscopy in Bariatric Surgery (Gastric Bypass): a prospective, single-blind, randomized, non-inferiority, and controlled study The main evaluation criterion is 24h post-operative pain assessed using visual analog scale (VAS). Secondary criteria included for clinical assessment: post 24h pain, excess weight loss, quality of life, appetite, complications, conversion rate; and for health-economics assessment : duration of surgical steps, length of stay, return to normal activity and their conversion to cost, consumables, estimation of indirect costs and benefits (e.g., robotics perception, publication).
In this study, main inclusion criteria include major obesity (IMC ≥ 35) with co-morbidities or morbid obesity (IMC ≥ 40), scheduled gastric bypass surgery Main contraindications are previous bariatric surgery and previous major abdominal surgeries To test robotic-assisted surgery non-inferiority on VAS pain score 24h post-surgery, a total of 128 patients (64 per arm) is to be included (alpha 2,5%; power 90%; drop-out rate: 5%).
The study will include 12 months of follow-up post-surgery for each patient. The total study duration is 2 years and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted surgery | Experimental | Procedure: Gastric bypassRobot-assisted (da Vinci surgical system) gastric bypass |
| Conventional laparoscopy | Active comparator | Procedure: Gastric bypassLaparoscopic gastric bypass |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient presenting with major obesity (BMI ≥ 35) with co-morbidities or morbid obesity (BMI ≥ 40)according to French HAS (Haute Autorité de Santé) and CNAMTS (Caisse nationale de l'assurance maladie des travailleurs salariés)criteria for whom gastric bypass is scheduled
- Male or female between 18 and 65 years old
- Patient registered with the French Social Security
- Patient having provided a written informed consent prior to enrolment
- Patient accepting to attend follow-up visits as required by study protocol
Key exclusion criteria (8 listed)
- Patient with a BMI ≥ 60
- Patient with a contraindication for laparoscopic gastric bypass with or without robotic assistance
- Patient having had prior bariatric surgery
- Patient having had prior major abdominal surgery
- Patient in exclusion period of another clinical study
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 |
|---|---|---|
| Gastric bypassGastric bypass | Procedure or surgery | Conventional laparoscopy, Robot-assisted surgery |
Primary outcome
24h postoperative pain
Time frame: 24h
Pain assessment 24h post surgery (visual analog scale)
10 secondary outcomes
Evaluation of post-operative pain
Time frame: 24h, 8 days, 1, 3, 6 and 12 months
Evaluation of quality of life (BAROS and GIQLI)
Time frame: At 1, 3, 6 and 12 months
Evaluation of appetite level
Time frame: At 8 days, 1, 3, 6 and 12 months
Percentage of excess weight loss
Time frame: At 8 days, 1, 3, 6 and 12 months
Conversion rate to conventional laparoscopy
Time frame: During the procedure (Day 0)
Nature of per-operative complications
Time frame: During the procedure (Day 0)
Nature of post-operative complications
Time frame: Following the procedure (Day 0) up to 12 months
Evaluation of operative times
Time frame: During the procedure (Day 0)
Evaluation of direct costs
Time frame: During the procedure (day 0) and up to 12 months
Evaluation of indirect costs
Time frame: Up to 12 months
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 10 Dec 2015.
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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.
Michel Vix principal investigator
Service de Chirurgie Générale et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric bypass in people with Morbid Obesity, run by IHU Strasbourg at 1 site in France.
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 5 inclusion and 8 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 10 Dec 2015. 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 France. 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?
24h postoperative pain (time frame: 24h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2015.