NCT01760512

Brief 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. It will also provide information on direct and indirect costs of surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2012

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 10, 2015

Status Verified

May 1, 2015

Enrollment Period

2.6 years

First QC Date

December 10, 2012

Last Update Submit

December 9, 2015

Conditions

Morbid Obesity

Keywords

Gastric bypassRobot-assisted surgeryConventional laparoscopyPain assessmentHealth economics outcomes

Outcome Measures

Primary Outcomes (1)

  • 24h postoperative pain

    Pain assessment 24h post surgery (visual analog scale)

    24h

Secondary Outcomes (10)

  • Evaluation of post-operative pain

    24h, 8 days, 1, 3, 6 and 12 months

  • Evaluation of quality of life (BAROS and GIQLI)

    At 1, 3, 6 and 12 months

  • Evaluation of appetite level

    At 8 days, 1, 3, 6 and 12 months

  • Percentage of excess weight loss

    At 8 days, 1, 3, 6 and 12 months

  • Conversion rate to conventional laparoscopy

    During the procedure (Day 0)

  • +5 more secondary outcomes

Study Arms (2)

Robot-assisted surgery

EXPERIMENTAL

Robot-assisted (da Vinci surgical system) gastric bypass

Procedure: Gastric bypass

Conventional laparoscopy

ACTIVE COMPARATOR

Laparoscopic gastric bypass

Procedure: Gastric bypass

Interventions

Gastric bypassPROCEDURE

Gastric bypass

Conventional laparoscopyRobot-assisted surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne

Strasbourg, 67 000, France

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Michel Vix

    Service de Chirurgie Générale et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2012

First Posted

January 4, 2013

Study Start

November 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 10, 2015

Record last verified: 2015-05

Locations

FR(1)