Clinical trial NCT05416645: Prevalence, Predictors and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy
Official title: Prevalence, Predictors, and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy Multicentric Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Keywords: laparoscopic sleeve gastrectomy
morbid obesity
GERD
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 1537
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study.
Primary purpose: TREATMENT

Brief summary: From January 2017 to January 2022, we looked at patients who had primary LSG and developed GERD. Before and after surgery, patients for LSG performed barium meal in Trendelenburg position and upper GIT endoscopy. Esophageal manometry and 24 h PH metery for patients who developed GERD.

Detailed description: Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study. Patients with morbid obesity, defined as a BMI of more than 40 or less than 35 with at least one comorbidity and ages ranging from 16 to 65, were patients' eligibility criteria for LSG. Patients under the age of 16 or over 65, as well as those with severe GERD, pregnancy, or inflammatory bowel disease, were excluded from the trial.

The data were recorded in a prospective manner in a computerized file, all patients signed the informed consent form after the description of the technique and possible postoperative morbidities.

Before and after surgery, patients for LSG performed barium meal in Trendelenburg position and upper GIT endoscopy. Esophageal manometry and 24 h PH metery for patients who developed GERD.

The study's purpose was to determine the prevalence of GERD symptoms, as well as potential predictors of GERD symptoms following LSG and how GERD symptoms were managed after LSG.

Eligibility criteria: Inclusion Criteria:

* Patients with morbid obesity defined as a BMI of more than 40 or
* BMI less than 35 with at least one comorbidity and
* ages ranging from 16 to 65, were patients'

Exclusion Criteria:

* Patients under the age of 16 or over 65,
* those with severe GERD,
* pregnancy, or
* inflammatory bowel disease,

Primary outcomes:
measure: GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire
timeFrame: one month
Secondary outcomes:
measure: Gastropexy
timeFrame: one month
measure: smoking
timeFrame: one month
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Ayman El Nakeeb
Study officials:
affiliation: Mansoura University, Gastrointestinal Surgery Center
name: Ayman El E Nakeeb
role: PRINCIPAL_INVESTIGATOR
References:
citation: Emile SH, Ghareeb W, Elfeki H, El Sorogy M, Fouad A, Elrefai M. Development and Validation of an Artificial Intelligence-Based Model to Predict Gastroesophageal Reflux Disease After Sleeve Gastrectomy. Obes Surg. 2022 Aug;32(8):2537-2547. doi: 10.1007/s11695-022-06112-x. Epub 2022 May 21.
citation: Chue KM, Goh DWX, Chua CME, Toh BC, Ong LWL, Wong WK, Lim CH, Tan JTH, Yeung BPM. The Hill's Classification Is Useful to Predict the Development of Postoperative Gastroesophageal Reflux Disease and Erosive Esophagitis After Laparoscopic Sleeve Gastrectomy. J Gastrointest Surg. 2022 Jun;26(6):1162-1170. doi: 10.1007/s11605-022-05324-x.
citation: Pavone G, Tartaglia N, Porfido A, Panzera P, Pacilli M, Ambrosi A. The new onset of GERD after sleeve gastrectomy: A systematic review. Ann Med Surg (Lond). 2022 Apr 5;77:103584. doi: 10.1016/j.amsu.2022.103584. eCollection 2022 May.
citation: Sancho Moya C, Bruna Esteban M, Sempere Garcia-Arguelles J, Ferrer Barcelo L, Monzo Gallego A, Mirabet Saez B, Mulas Fernandez C, Albors Baga P, Vazquez Prado A, Oviedo Bravo M, Montalva Oron E. The Impact of Sleeve Gastrectomy on Gastroesophageal Reflux Disease in Patients with Morbid Obesity. Obes Surg. 2022 Mar;32(3):615-624. doi: 10.1007/s11695-021-05808-w. Epub 2022 Jan 20.
citation: El Nakeeb A, Aldossary H, Zaid A, El Sorogy M, Elrefai M, Attia M, Sewefy AM, Kayed T, Aldawsari MA, Al Dossari HM, Mohammed MM. Prevalence, Predictors, and Management of Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy: a Multicenter Cohort Study. Obes Surg. 2022 Nov;32(11):3541-3550. doi: 10.1007/s11695-022-06264-w. Epub 2022 Sep 10.