An observational study in Sleeve, Postoperative Pain and Obese Adult Male, sponsored by American Hospital of Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by American Hospital of Paris · Observational
Endoscopic sleeve gastroplasty (ESG) is a new mini-invasive technique proposed to treat obesity (1-5). According to the endoscopic procedure compared to videolaparoscopy, this technique is supposed less painful and provide a reduction in postoperative complications (6-7). There are rare informations about the influence of ESG on postoperative painful (8). In this observational pilot study, the investigators prospectively assessed the postoperative analgesia concerns for this recent technique.
The authors evaluated the pain relief, including morphine consumption, pain and satisfaction scores and morbidity following a new endoscopic sleeve gastroplasty scheduled on the first 100 consecutive patients
Endoscopic sleeve gastroplasty (ESG) is a new mini-invasive technique proposed to treat obesity (1-5). According to the endoscopic procedure compared to videolaparoscopy, this technique is supposed less painful and provide a reduction in postoperative complications (6-7). There are rare informations about the influence of ESG on postoperative painful (8). In this observational pilot study, the investigators prospectively assessed the postoperative analgesia concerns for this recent technique.
The first 100 consecutive patients scheduled to undergo ESG performed by the same operator (LK) according to a standardized technique, were included (Apollo Endosurgery, UK, Ltd). All the patients were informed and gave their consentment. After premedication using oral hydroxyzine, the anesthesia was standardized using intravenous sufentanil, propofol, dexamethasone and succinylcholine to facilitate oral tracheal intubation using videolaryngoscopy (MacGrath). After to control empty stomach without injury by initial endoscopy, a dose of intravenous atracurium was administered to help mechanical ventilation during stomach continuous CO2 insufflation and its EtCO2 monitoring. Anesthesia is maintained using sevoflurane inhalation, adjusted to get a 40-60 on the bispectral index of the electroencephalogram (BIS, Aspect Medical Systems, Newton, MA). Before discontinuation of volatile anesthetic and tracheal extubation, the postoperative analgesia was started using intravenous paracetamol 1 g, parecoxib 40 mg and tramadol 100 mg. Upon waking, and after endotracheal extubation, intravenous morphine was titrated in the recovery room if the Visual Analog Scale (VAS) pain score was greater than 3/10. Then, a standardized multimodal analgesia protocol was implemented starting in the recovery room, consisting of intravenous paracetamol, phloroglucinol and patient-controlled intravenous morphine (PCA; bolus dose 1 mg, lockout interval 5 min). If additional anxiolytic or relaxant treatment was required, intravenous hydroxyzine and sublingual amitriptyline (8-14 mg) were administered. Patient has to stay strictly fasting the first day following the procedure. Each patient was treated using esomeprazole 40 mg twice a day during one month. The investigators recorded all the demographic and postoperative pain relief data and morbidity.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 622 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →American Hospital of Paris is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The first 100 consecutive adult patients scheduled to undergo ESG performed by the same operator (LK) according to a standardized technique, were included (Apollo Endosurgery, UK, Ltd). All the patients were informed and gave their consentment.
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Endoscopic sleeve gastroplasty Obesity adult patient
Exclusion Criteria:
previous bariatric surgery (Kuzmack gastric band, sleeve or bypass) patient older less 18 years
The first 100 consecutive patients scheduled to undergo ESG performed by the same operator (LK) according to a standardized technique, were included (Apollo Endosurgery, UK, Ltd). All the patients were informed and gave their consentment. After premedication using oral hydroxyzine, the anesthesia was standardized using intravenous sufentanil, propofol, dexamethasone and succinylcholine to facilitate oral tracheal intubation using videolaryngoscopy (MacGrath). After to control empty stomach without injury by initial endoscopy, a dose of intravenous atracurium was administered to help mechanical ventilation during stomach continuous CO2 insufflation and its EtCO2 monitoring. Anesthesia is maintained using sevoflurane inhalation, adjusted to get a 40-60 on the bispectral index of the electroencephalogram (BIS, Aspect Medical Systems, Newton, MA). Before discontinuation of volatile anesthetic and tracheal extubation, the postoperative analgesia was started using intravenous paracetamol 1 g
postoperative Morphine consumption
Morphine consumption following the endoscopic sleeve gastroplasty
Time frame: first day postoperative period
postoperative pain scores
Visual or Numeric Pain Score (Zero is equivalent to no pain and 10 indicates the worst possible pain) following the endoscopic sleeve gastroplasty
Time frame: first day postoperative period
number of patient requiring morphine
rate of the patient having a postoperative morphine requirement
Time frame: first day postoperative period
postoperative nausea and vomiting
number of patients requiring anti-emisis for nausea-vomiting event
Time frame: first day postoperative period
Plan to share: Undecided — It was a pilot and observational study concerning the pain management of a new endoscopic bariatric technique, the endoscopic sleeve gastroplasty
Ran from Jan 2018 to primary completion in Aug 2020, 31 months.
Of 347 non-industry observational studies under Pain, Postoperative, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 31 months is above that.
Counting every sponsor, half of 352 studies reached it within 14 months; a quarter within 6 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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American Hospital of Paris