Sleevepain & SleeveNCT07875283
Analgesia After Endoscopic Sleeve Gastroplasty
An observational study of Sleeve and Postoperative Pain, run by American Hospital of Paris at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleeve, Postoperative Pain, Obese Adult Male
- What is being tested?
- Postoperative analgesia
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 31 Aug 2020
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Endoscopic sleeve gastroplasty Obesity adult patient
Who cannot join
- previous bariatric surgery (Kuzmack gastric band, sleeve or bypass) patient older less 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain Management in Endoscopic Sleeve Gastroplasty: an Observational Study of the First 100 Cases
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
Read the detailed description
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.
- Conditions
- Sleeve, Postoperative Pain, Obese Adult Male
- Being tested
- Postoperative analgesia
- Keywords
- pain, endoscopic sleeve, postoperative
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative analgesiaProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative Morphine consumption
Morphine consumption following the endoscopic sleeve gastroplasty
Measured: first day postoperative period
Secondary outcomes (2)
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
Measured: first day postoperative period
number of patient requiring morphine
rate of the patient having a postoperative morphine requirement
Measured: first day postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Jan 2018
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SleeveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Hospital of Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilles BOCCARA, American Hospital of Paris
- Investigators
- Luc Karsenty, Professor, Study director, American Hospital of Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875283
- Sponsor's protocol ID
- Pain and Sleeve AHP
- Other IDs
- Boccara Gilles
- Acronym
- pain & Sleeve
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It was a pilot and observational study concerning the pain management of a new endoscopic bariatric technique, the endoscopic sleeve gastroplasty
Publications
Ford AC, Wright-Hughes A, Alderson SL, Ow PL, Ridd MJ, Foy R, Bianco G, Bishop FL, Chaddock M, Cook H, Cooper D, Fernandez C, Guthrie EA, Hartley S, Herbert A, Howdon D, Muir DP, Nath T, Newman S, Smith T, Taylor CA, Teasdale EJ, Thornton R, Farrin AJ, Everitt HA; ATLANTIS trialists. Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment in primary care (ATLANTIS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Nov 11;402(10414):1773-1785. doi: 10.1016/S0140-6736(23)01523-4. Epub 2023 Oct 16.
PubMed 37858323Moy BM, Volk S, Richards B, Guduguntla BA, Schulman AR. Use of Postoperative Opioid Therapy Following Endoscopic Sleeve Gastroplasty. Am J Gastroenterol. 2024 Jun;119(6):1186-1181. doi: 10.14309/ajg.0000000000002665. Epub 2024 Feb 23.
PubMed 38235688Lopez-Nava G, Sharaiha RZ, Vargas EJ, Bazerbachi F, Manoel GN, Bautista-Castano I, Acosta A, Topazian MD, Mundi MS, Kumta N, Kahaleh M, Herr AM, Shukla A, Aronne L, Gostout CJ, Abu Dayyeh BK. Endoscopic Sleeve Gastroplasty for Obesity: a Multicenter Study of 248 Patients with 24 Months Follow-Up. Obes Surg. 2017 Oct;27(10):2649-2655. doi: 10.1007/s11695-017-2693-7.
PubMed 28451929Fayad L, Adam A, Schweitzer M, Cheskin LJ, Ajayi T, Dunlap M, Badurdeen DS, Hill C, Paranji N, Lalezari S, Kalloo AN, Khashab MA, Kumbhari V. Endoscopic sleeve gastroplasty versus laparoscopic sleeve gastrectomy: a case-matched study. Gastrointest Endosc. 2019 Apr;89(4):782-788. doi: 10.1016/j.gie.2018.08.030. Epub 2018 Aug 25.
PubMed 30148991Abu Dayyeh BK, Bazerbachi F, Vargas EJ, Sharaiha RZ, Thompson CC, Thaemert BC, Teixeira AF, Chapman CG, Kumbhari V, Ujiki MB, Ahrens J, Day C; MERIT Study Group; Galvao Neto M, Zundel N, Wilson EB. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet. 2022 Aug 6;400(10350):441-451. doi: 10.1016/S0140-6736(22)01280-6. Epub 2022 Jul 28.
PubMed 35908555Fogel R, De Fogel J, Bonilla Y, De La Fuente R. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc. 2008 Jul;68(1):51-8. doi: 10.1016/j.gie.2007.10.061. Epub 2008 Mar 19.
PubMed 18355825