Prevalence, Predictors and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy

NCT05416645 | Completed DMC

• 1 other identifier: LSG
• Study Type: interventional
• Target: 1,537
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux

Keywords

laparoscopic sleeve gastrectomy; morbid obesity; GERD

Outcome Measures

Primary Outcomes (1)

• GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire

  GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire including GERD symptoms easch one scaled from 1 to 5 the less score the better out come (1 the best and 5 is the worset)

  one month

Secondary Outcomes (2)

• Gastropexy

  one month

• smoking

  one month

Study Arms (2)

Patients in group I (G1) had GERD

ACTIVE COMPARATOR

Patients developed GERD after LSG

Procedure: patients with GERD after LSG

Patients in group I (G2) had no GERD

ACTIVE COMPARATOR

Patients not developed GERD after LSG

Procedure: patients with GERD after LSG

Interventions

patients with GERD after LSG PROCEDURE

patients with GERD after LSG

Also known as: GERD after LSG

Patients in group I (G1) had GERD; Patients in group I (G2) had no GERD

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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'

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Ayman El Nakeeb

Al Mansurah, 356111, Egypt

Location

Related Publications (5)

• 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.

  PMID: 35596915 RESULT

• 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.

  PMID: 35445323 RESULT

• 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.

  PMID: 35432994 RESULT

• 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.

  PMID: 35048247 RESULT

• 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.

  PMID: 36087223 DERIVED

Related Links

• mansoura university

MeSH Terms

Conditions

Gastroesophageal Reflux; Obesity, Morbid

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayman El E Nakeeb

  Mansoura University, Gastrointestinal Surgery Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Model Details: Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study.

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 13, 2022
• Study Start: January 1, 2017
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: available for any researcher at any time
• Access Criteria: e-mail elnakeebayman@yahoo.com

Locations

EG (1)