Comparison of minimally invasive versus conventional laparoscopic (keyhole) bariatric surgery
| ISRCTN | ISRCTN49101970 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49101970 |
- Submission date
- 19/02/2021
- Registration date
- 04/03/2021
- Last edited
- 05/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Laparoscopic Sleeve Gastrectomy (also called bariatric surgery) is the most performed bariatric surgery worldwide with 155,000 procedures in the United States in 2018 and 36,000 in France in 2016.
LSG surgery is done in a hospital under general anesthesia. The surgeon will make about five small cuts in the belly. He or she will do the surgery using a thin, long, telescope with a tiny camera at the end. Instruments pushed through the incisions will be used to remove about 80% of the stomach. The surgeon will do the procedure using images on a TV screen in the operating room.
This surgery takes out the part of the stomach that curves outward, called the fundus. After the fundus is taken out, the surgeon will close the rest of the stomach into a tube shape that looks like a banana or the sleeve of the shirt, hence the name "sleeve gastrectomy."
A recent systematic review demonstrated the safety and efficacity of single incision laparoscopic sleeve gastrectomy. But to our knowledge, no trial has compared traditional multiport sleeve gastrectomy to single incision laparoscopic sleeve gastrectomy. The aim of this study is to compare these two techniques and to determine the superiority of one of them considering the following aspects: postoperative pain, postoperative scars esthetic aspect, postoperative sex life along with postoperative diurnal and nocturnal quality of life.
Who can participate?
Adult patients with body mass index >40 kg/m² or with a body mass index >35 kg/m² with serious comorbidity such as obstructive sleep apnea, diabetes mellitus or hypertension undergoing laparoscopic sleeve gastrectomy as a primary bariatric procedure.
What does the study involve?
As participants undergoing sleeve gastrectomy (regardless of number of used ports) sign up for a scheduled postoperative follow-up, no additional outpatient visit or examination is required in this study.
What are the possible benefits and risks of participating?
This study is a non-randomized trial. Patients will be freely addressed to one of two teams of surgeons who adopted and routinely perform exclusively one of two surgical approaches (conventional laparoscopy or single-port laparoscopic sleeve gastrectomy). Therefore, no specific additional benefits and risks are expected from the participation of patients in the trial.
Where is the study run from?
Antoine Beclere Hospital of Assistance Publique-Hôpitaux de Paris (France)
When is the study starting and how long is it expected to run for?
January 2021 to June 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Hadrien Tranchart
hadrien.tranchart@aphp.fr
Contact information
Public
Department of minimally invasive digestive surgery
Hôpital Antoine Béclère
157 rue de la porte de trivaux
Clamart
92140
France
 ORCID ID |
0000-0002-2562-6507 |
|---|---|
| Phone | +33 (0)1 45 37 43 47 |
| joseph.derienne@aphp.fr |
Scientific
Department of minimally invasive digestive surgery
Hôpital Antoine Béclère
157 rue de la porte de trivaux
Clamart
92140
France
| ORCID ID |
0000-0003-2173-2828 |
|---|---|
| Phone | +33 (0)1 45 37 43 47 |
| hadrien.tranchart@aphp.fr |
Study information
| Study design | Single-centre prospective non-randomized controlled observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Single incision laparoscopic sleeve gastrectomy versus conventional multiport sleeve gastrectomy (ONE SLEEVE): a prospective non-randomized controlled trial |
| Study acronym | ONE SLEEVE |
| Study objectives | Single incision laparoscopic sleeve gastrectomy provides an improved postoperative outcome compared to conventional multiport sleeve gastrectomy. |
| Ethics approval(s) | No ethics approval is required for this study, since it is a nonrandomized controlled trial of a routine procedure. This was validated with the clinical research unit of the Paris-Sud University. |
| Health condition(s) or problem(s) studied | Laparoscopic sleeve gastrectomy |
| Intervention | Patients undergo a laparoscopic sleeve gastrectomy either using a single incision or a conventional multiport technique depending on the surgical team they are assigned to. This is a routine procedure. There is a one-year follow-up which is not additional to usual treatment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | A written questionnaire with 0-10 scales is completed at 3 months evaluating: 1. Scar esthetic impact on patients 2. Postoperative parietal pain 3. Impact of the scar on postoperative sex life 4. Scar impact on diurnal quality of life (daily basis movements, work) 5. Scar impact on nocturnal quality of life (sleep) |
| Secondary outcome measures | 1. 6 and 12 months written questionnaires with 0-10 scales evaluating: 1.1. Scar esthetic impact on patients 1.2. Postoperative parietal pain 1.3. Impact of the scar on postoperative sex life 1.4. Scar impact on diurnal quality of life (daily basis movements, work) 1.5. Scar impact on nocturnal quality of life (sleep) 2. 90 days postoperative Morbi-mortality from patient records 3. Bodyweight (kg) (at baseline, 3, 6 and 12 months) 4. Body Mass index (kg/m²) (at baseline, 3, 6 and 12 months) 5. Co-morbidities (at baseline and 12 months) from patient records 6. Incisional hernia rate (at 12 months) with clinical and radiological (CT scan) evaluation |
| Overall study start date | 01/01/2021 |
| Completion date | 01/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 176 |
| Key inclusion criteria | 1. Consecutive patients undergoing laparoscopic sleeve gastrectomy 2. Decision for intervention after multidisciplinary discussion 3. Sleeve gastrectomy as a primary bariatric procedure 4. Body mass index >40 kg/m² or >35 kg/m² with severe comorbidities. |
| Key exclusion criteria | 1. Previous upper abdominal surgery (except laparoscopic cholecystectomy) 2. Patient under guardianship and trusteeship |
| Date of first enrolment | 01/06/2021 |
| Date of final enrolment | 01/06/2023 |
Locations
Countries of recruitment
- France
Study participating centre
157 rue de la porte de trivaux
Clamart
92140
France
Sponsor information
Hospital/treatment centre
Department of minimally invasive digestive surgery
157 rue de la porte de trivaux
Clamart
92140
France
| Phone | +33 (0)1 45 37 43 39 |
|---|---|
| ibrahim.dagher@aphp.fr | |
| Website | http://www.aphp.fr/contenu/hopital-antoine-beclere-1 |
"ROR" |
https://ror.org/04sb8a726 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Editorial Notes
05/07/2024: The total final enrolment was changed from 100 to 176.
20/06/2023: Total final enrolment added.
12/12/2022: The intention to publish date was changed from 01/12/2022 to 01/12/2024.
08/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/12/2022 to 01/06/2023.
2. The overall trial end date was changed from 01/12/2022 to 01/06/2024.
30/04/2021: The recruitment start date has been changed from 01/04/2021 to 01/06/2021.
03/03/2021: Trial's existence confirmed by Hopital Antoine-Beclere.
