Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-01 @ 4:30 AM
Study NCT ID:
NCT01513005
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2012-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery
Sponsor:
Centre Hospitalier Universitaire, Amiens
Organization:
Study Overview
Official Title:
Feasibility of Day Case Management by Laparoscopic Sleeve Gastrectomy for Obesity: a Pilot Study
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GASTRAMBU
Brief Summary:
The aim of this study is to determinate the feasibility of the Laparoscopic Sleeve Gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be proposed as a Day-Case surgery.
Detailed Description:
The purpose of this study is to investigate whether the patients with morbid obesity requiring a surgical approach by Laparoscopic Sleeve Gastrectomy could be operated according to a "day-case surgery" modality.
The sequence of this study is the following:
1. patients consultation for bariatric management: during this consultation, the investigator is looking for exclusion criteria and prescribes laboratory tests.
2. medical records of each patient are reviewed by an obesity-related staff: Laparoscopic Sleeve Gastrectomy is proposed.
3. during a second consultation, the surgeon informed the patient about the proposition of the staff and his potential inclusion in this study
4. after obtained his consent, the surgical procedure is planned and Laparoscopic Sleeve Gastrectomy is done in the Day-Case Surgery Unit.
5. the following day the surgery, a nurse calls the patient to identify a potential postoperative outcome (nausea, vomiting, uncontrolled pain...)
6. the 8th postoperative day, a consultation is done with laboratory tests and dietary follow-up.
7. follow-up consultations are scheduled at 3, 6 and 12 months to evaluate the efficiency of the surgery procedure.
The sequence of this study is the following:
1. patients consultation for bariatric management: during this consultation, the investigator is looking for exclusion criteria and prescribes laboratory tests.
2. medical records of each patient are reviewed by an obesity-related staff: Laparoscopic Sleeve Gastrectomy is proposed.
3. during a second consultation, the surgeon informed the patient about the proposition of the staff and his potential inclusion in this study
4. after obtained his consent, the surgical procedure is planned and Laparoscopic Sleeve Gastrectomy is done in the Day-Case Surgery Unit.
5. the following day the surgery, a nurse calls the patient to identify a potential postoperative outcome (nausea, vomiting, uncontrolled pain...)
6. the 8th postoperative day, a consultation is done with laboratory tests and dietary follow-up.
7. follow-up consultations are scheduled at 3, 6 and 12 months to evaluate the efficiency of the surgery procedure.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-A01178-31 | OTHER | ID-RCB | View |