Skip to content

Comparison of minimally invasive versus conventional laparoscopic (keyhole) bariatric surgery

Single incision laparoscopic sleeve gastrectomy versus conventional multiport sleeve gastrectomy (ONE SLEEVE): a prospective non-randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN49101970
Enrollment
100
Registered
2021-03-04
Start date
2021-06-01
Completion date
Unknown
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic sleeve gastrectomy Surgery

Interventions

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

Sponsors

Hôpital Antoine-Béclère
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Previous upper abdominal surgery (except laparoscopic cholecystectomy) 2. Patient under guardianship and trusteeship

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

France

Contacts

Public ContactJoseph Derienne
joseph.derienne@aphp.fr+33 (0)1 45 37 43 47

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026