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Benefit of Single Port-surgery in Sleeve Gastrectomy

NCT02360176 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2020-09-16

No results posted yet for this study

Summary

Demonstrate non-inferiority of the single port for sleeve gastrectomy compared to the reference method in terms of complications using a score of morbidity and mortality at 6 and 24 months: Rate of fistula, intra and extra abdominal abcess, hemorrhage, gastric stenosis, splenic lesions, hernia, residual gastric pouch and mortality

Conditions

  • Surgical Treatment of Obesity

Interventions

PROCEDURE

Sleeve gastrectomy single port

Bariatric surgery: one incision of 2.5 to 3 cm

PROCEDURE

Sleeve gastrectomy multi trocar

Bariatric surgery: 4 to 7 incisions of 1 to 2 cm

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Guillaume Pourcher, MD PhD · Montsouris Institut

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-04
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02360176 on ClinicalTrials.gov