Laparoscopic Clip-Gastroplasty With The Use Of Bariclip

NCT ID: NCT05557084

Last Updated: 2022-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-03-31

Brief Summary

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Sleeve gastrectomy, the most commonly performed bariatric surgery procedure, carries limitations both short-term including postoperative complications such as hemorrhage and gastric fistula and long-term such as weight regain and gastro-esophageal reflux. A new procedure has been proposed to overcome many of these limitations: laparoscopic vertical clip gastroplasty (LVCG) with Bariclip. Primary outcome were major postoperative complications. Secondary outcomes included weight loss, incidence of de-novo GERD and comorbidity resolution.

Detailed Description

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Methods. The investigators performed a review of data from a prospectively collected database. All patients submitted to primary LVCG were examined. Patients were submitted to LVCG Between July 2021 and March 2022. Collected data included demographic factors, pre-operative weight, pre-operative BMI, operative time, surgical complications, and clinical outcomes in terms of short and mid-term weight loss.

Conditions

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Obesity Obesity, Abdominal Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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laparoscopic vertical clip gastroplasty (LVCG) with Bariclip.

The investigator performed laparoscopic vertical clip gastroplasty, This procedure consists of a nonadjustable clip that is vertically placed around the stomach, parallel to the lesser curvature, mimicking the effect of sleeve gastrectomy. The clip restricts oral intake, the anatomy of the stomach is not permanently changed, the small bowel remains untouched, the digestive pathway is not diverted, no stapling or resection are required and the magnitude of restriction is supposed to remain constant during the years. The vertical clip is thus placed without risks of staple line leak, malabsorption side effects, changes in anatomy, and is potentially reversible \[9\]. creating a 4-cm window to enter the lesser sac while lifting the stomach to create sufficient space to be able to suture. Plication of the antrum for 3-5 cm is performed. Fluid testing for patency is performed with methylene blue or normal saline and the procedure is terminate.

Intervention Type PROCEDURE

Other Intervention Names

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Bariclip

Eligibility Criteria

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Inclusion Criteria

BMI \> 40 BMI \> 35 and comorbidities BMI \> 30 with poorly controlled Diabetes mellitus II or hypertension

Exclusion Criteria

Alcoholism Drug addiction Psychiatric Disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

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Paolo Gentileschi

Head of Department of Bariatric and Metabolic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Michela Campanelli

Rome, RM, Italy

Site Status

Department of Bariatric and Metabolic Surgery, San Carlo of Nancy Hospital and University of Rome "Tor Vergata", Rome, Italy

Roma, , Italy

Site Status

Countries

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Italy

References

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Noel P, Eddbali I, Nedelcu M. Laparoscopic Clip Gastroplasty with the BariClip. Obes Surg. 2020 Dec;30(12):5182-5183. doi: 10.1007/s11695-020-04803-x.

Reference Type BACKGROUND
PMID: 32996101 (View on PubMed)

Noel P, Nedelcu AM, Eddbali I, Zundel N. Laparoscopic vertical clip gastroplasty - quality of life. Surg Obes Relat Dis. 2018 Oct;14(10):1587-1593. doi: 10.1016/j.soard.2018.07.013. Epub 2018 Jul 20.

Reference Type BACKGROUND
PMID: 30449515 (View on PubMed)

Other Identifiers

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UNRome1

Identifier Type: -

Identifier Source: org_study_id

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