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Clip Ascent and Sleeve Gastrectomy

NCT ID: NCT03932968

Last Updated: 2021-12-14

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

223 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-17

Study Completion Date

2019-06-13

Brief Summary

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This is a single institution study. All patients, one year after sleeve gastrectomy will be included. All will have a CT scan looking for clip ascent. For patients with chronic gastric symptoms such as retrosternal burning, regurgitations, and epigastric pain, a pH-metry will be performed. Those symptoms appeared at least 6 months after the surgery. A second consultation is done one year after. The aim of the study is to correlate clip ascent, pyrosis proved by ph-metry and epigastric symptoms after sleeve gastrectomy. The demographic data collection confirms the definition of clip ascent, define its frequency, and look for correlation with the median weight loss.

Detailed Description

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There is a strong association between gastric reflux and obesity. A severe reflux is a contraindication for a sleeve gastrectomy for some surgeons. However the impact of sleeve gastrectomy on reflux is not clear. A de novo reflux is described for 2 to 18% of patients and many patients have unclear epigastric symptoms. One of the cause could be clip ascent which could justify a second surgery. This is a single institution study. All patients, one year after sleeve gastrectomy will be included. All will have a CT scan looking for clip ascent. For patients with gastric symptoms such as retrosternal burning, regurgitations, and epigastric pain, a pH-metry will be performed. A second consultation is done one year after. The aim of the study is to correlate clip ascent, pyrosis proved by ph-metry and epigastric symptoms after sleeve gastrectomy. The demographic data collection, confirms the definition of clip ascent, define its frequency, and look for correlation with the median weight loss. A medical information note is given to every patient at the first consultation.

Conditions

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Sleeve Gastrectomy Obesity

Keywords

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sleeve gastrectomy clip ascent oesogastric reflux sleeve gastrectomy follow-up

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Symptomatic pain

For patients with gastric symptoms such as retrosternal burning, regurgitations, and epigastric pain, a pH-metry during 24 hours will be performed.

pH-metry during 24 hours

Intervention Type PROCEDURE

For patients with gastric symptoms such as retrosternal burning, regurgitations, and epigastric pain, a pH-metry will be performed

Control

patients after a sleeve gastrectomy without symptomatic pain

No interventions assigned to this group

Interventions

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pH-metry during 24 hours

For patients with gastric symptoms such as retrosternal burning, regurgitations, and epigastric pain, a pH-metry will be performed

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* sleeve gastrectomy operated for at least 1 year

Exclusion Criteria

* acute abdominal pain,
* epigastric pain occuring after the surgery (no 6 months delay),
* pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PASCALE KARILA-COHEN, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital Bichat

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2017-A01608-45

Identifier Type: OTHER

Identifier Source: secondary_id

NI17015J

Identifier Type: -

Identifier Source: org_study_id