Hiatal Interrogation in Sleeve Gastrectomy

NCT03527810 | Terminated

• 1 other identifier: Pro47769
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The subject will undergo standard pre-operative preparation. Subjects will be evaluated for the presence of bothersome GERD symptoms by GERD questionnaires and use of Proton-Pump Inhibitor (PPI) medications. Those eligible will be approached at their preoperative appointment about participation in the study and consent will be reviewed with subject. Signed consent will be collected from the subject prior to entry into the operating room. After induction of anesthesia, the subject will be randomized to sleeve gastrectomy with or without interrogation of the hiatus. The SG will be performed as per standard approaches already described. In those randomized to interrogation, the hiatus will be opened posteriorly with preservation of the phreno-esophageal ligament where possible, as per standard described techniques. Dissection into the mediastinum will be stopped if no hernia is seen or when appropriate intra-abdominal length of 2 cm of esophagus is created. Once opened, the Hiatal Surface Area (appendix B)17 will be measured, calculated and recorded and when possible, a photo taken of the area. Repair of the crura will then be performed around the sizing tube used to create the sleeve with enough space to allow a 5 mm instrument to be easily inserted. Permanent sutures will be placed posterior to the esophagus. Subjects will be recovered and be discharged per standard protocol. Evaluation for reflux will be conducted pre-operatively and then 3, 6, 12 and 24 months (+/- 30 days) after surgery or on demand if symptoms occur between follow up periods. Many groups advocate the use of PPI for the first 30 days after bariatric surgery - accordingly assessments of reflux will not occur until 3 months post operatively when most groups stop prophylactic PPI use. A visit within the first 30 days after surgery (+/- 15 days) should occur to evaluate for potential complications of surgery.

Conditions

Sleeve Gastrectomy

Keywords

sleeve gastrectomy; hiatal interrogation; GERD

Outcome Measures

Primary Outcomes (1)

• Change in patients dependent on proton pump inhibitors therapy for confirmed GERD.

  Statistically significant change in total patients on PPI therapy for confirmed GERD (by either questionnaire or pH test confirmed GERD).

  6 months

Secondary Outcomes (4)

• Time free from GERD symptoms compared between both groups

  24 months

• Time free from GERD medications compared between both groups

  24 months

• Number of patients with symptomatic hiatal hernias at 24 months

  24 months

• Number of patients requiring secondary procedures for reflux at 12, 24 months

  12, 24 months

Study Arms (2)

Sleeve Gastrectomy With Interrogation of Hiatus

EXPERIMENTAL

In those randomized to interrogation, the hiatus will be opened posteriorly during surgical procedure intervention with preservation of the phreno-esophageal ligament where possible, as per standard described techniques. Dissection into the mediastinum will be stopped if no hernia is seen or when appropriate intra-abdominal length of 2 cm of esophagus is created. Once opened, the Hiatal Surface Area will be measured, calculated and recorded and when possible, a photo taken of the area. Repair of the crura will then be performed around the sizing tube used to create the sleeve with enough space to allow a 5 mm instrument to be easily inserted. Permanent sutures will be placed posterior to the esophagus.

Procedure: Sleeve Gastrectomy With Interrogation of Hiatus

Sleeve Gastrectomy Without Interrogation of Hiatus

ACTIVE COMPARATOR

In those randomized without interrogation, the stomach is reduced to about 15% of its original size, by surgical removal of a large portion of the stomach along the greater curvature. The procedure involves a longitudinal resection of the stomach starting from the antrum at the point 5-6 cm from the pylorus and finishing at the fundus close to the cardia.\[1\] The remaining gastric sleeve is calibrated with a bougie. Most surgeons prefer to use a bougie between 36-40 Fr with the procedure and the ideal approximate remaining size of the stomach after the procedure is about 150 mL.

Procedure: Sleeve Gastrectomy Without Interrogation of Hiatus

Interventions

Sleeve Gastrectomy Without Interrogation of Hiatus PROCEDURE

Weight-loss procedure to reduce the stomach.

Sleeve Gastrectomy Without Interrogation of Hiatus

Sleeve Gastrectomy With Interrogation of Hiatus PROCEDURE

Weight-loss procedure to reduce the stomach with hiatal repair.

Sleeve Gastrectomy With Interrogation of Hiatus

Eligibility Criteria

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

You may qualify if:

• Any patient deemed a candidate for Sleeve Gastrectomy.
• Age 18 years or older.
• Body Mass Index equal or greater to 40 without comorbidities OR Body Mass Index equal or greater than 35 with at least one obesity co-morbidity.

You may not qualify if:

• Daily Proton Pump Inhibitor or H2 blocker use for typical GERD symptoms during Screening day to Surgery day
• GERD Health Related Quality of Life (HRQL) questionnaire score greater than or equal to 15.
• Hiatal hernia greater than 2cm by either preoperative endoscopy or Upper gastrointestinal (UGI) within one year of evaluation for bariatric surgery.
• The Los Angeles classification of the severity of reflux esophagitis: C,D
• Barrett's esophagus
• Dysphagia with poor esophageal function measured by motility testing.
• Does not meet National Institute of Health's weight loss surgery criteria.
• Inability to commit to no pregnancy for 18 months post operatively.
• Gastroparesis as defined by 4 hour nuclear emptying study.
• Previous bariatric surgery.
• Eosinophilia esophagitis.

Sponsors & Collaborators

• Miguel Burch: lead
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Miguel Burch, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Director, Minimally Invasive Surgery

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: May 17, 2018
• Study Start: September 4, 2018
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)