Analgesia After Endoscopic Sleeve Gastroplasty

NCT07875283 | Completed

• 2 other identifiers: Pain and Sleeve AHPBoccara Gilles
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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). 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

Conditions

Sleeve; Postoperative Pain; Obese Adult Male

Keywords

pain; endoscopic sleeve; postoperative

Outcome Measures

Primary Outcomes (1)

• postoperative Morphine consumption

  Morphine consumption following the endoscopic sleeve gastroplasty

  first day postoperative period

Secondary Outcomes (2)

• postoperative pain scores

  first day postoperative period

• number of patient requiring morphine

  first day postoperative period

Other Outcomes (1)

• postoperative nausea and vomiting

  first day postoperative period

Interventions

Postoperative analgesia PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Endoscopic sleeve gastroplasty Obesity adult patient

You may not qualify if:

• previous bariatric surgery (Kuzmack gastric band, sleeve or bypass) patient older less 18 years

Sponsors & Collaborators

• American Hospital of Paris: lead

Study Sites (1)

American Hospital of Paris

Neuilly-sur-Seine, 92200, France

Location

Related Publications (6)

• 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.

  PMID: 37858323 BACKGROUND

• Moy 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.

  PMID: 38235688 BACKGROUND

• Lopez-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.

  PMID: 28451929 BACKGROUND

• Fayad 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.

  PMID: 30148991 BACKGROUND

• Abu 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.

  PMID: 35908555 BACKGROUND

• Fogel 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.

  PMID: 18355825 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Luc Karsenty, Professor

  American Hospital of Paris, France

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesiologist, MD, PhD

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 15, 2026
• Study Start: January 1, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: October 15, 2026

Record last verified: 2026-10

Locations

FR (1)