NCT03527810

Hiatal Interrogation in Sleeve Gastrectomy

Terminated NA Last updated 1 April 2022

What this trial tests

NA trial testing Sleeve Gastrectomy Without Interrogation of Hiatus in Sleeve Gastrectomy in 16 participants. Terminated before completion.

Timeline

4 September 2018

Primary endpoint
7 March 2022

7 March 2022

Quick facts

Lead sponsor	Miguel Burch
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	16
Start date	4 September 2018
Primary completion	7 March 2022
Estimated completion	7 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Sleeve Gastrectomy Without Interrogation of Hiatus
• Sleeve Gastrectomy With Interrogation of Hiatus

Conditions studied

• Sleeve Gastrectomy — all drugs for Sleeve Gastrectomy →

Sponsor

Miguel Burch

Who can join

18 and older, any sex, with Sleeve Gastrectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.