NCT04168060

Brief Summary

The purpose of this study is to identify if there is a benefit in routine dissection of the diaphragmatic crura during sleeve gastrectomy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

November 22, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

5.5 years

First QC Date

November 15, 2019

Last Update Submit

May 28, 2025

Conditions

Sleeve Gastrectomy

Keywords

sleeve gastrectomycrura dissectionbariatric surgery

Outcome Measures

Primary Outcomes (4)

  • Change in Perioperative Symptoms as assessed by the Intermediate and Late-Post Operative Pain, Nausea and Dysphagia Questionnaire

    The Intermediate and Late Post-Operative Pain, Nausea and Dysphagia Questionnaire is a 7-item questionnaire with scores ranging 0-40 with the higher score indicating severe symptoms.

    Day 1, 12 months

  • Change in Perioperative Symptoms as assessed by the Rhodes Index of Nausea, Vomiting and Retching Questionnaire

    The Rhodes Index of Nausea, Vomiting and Retching Questionnaire is an 8-item questionnaire with scores ranging from 0 to 32 with a higher score indicating increased symptoms of nausea.

    Day 1, 12 months

  • Change in Perioperative Symptoms as assessed by the Gastroesophageal Reflux Disease-Questionnaire (GERD-Q)

    The GERD-Q has a scoring range between 0-18 with a higher score indicating increased likelihood of GERD.

    Baseline, 12 months

  • Change in Perioperative Symptoms as assessed by the Brief Esophageal Dysphagia Questionnaire (BEDQ)

    The BEDQ has a scoring range between 0-40 with a higher score indicating increased symptoms of dysphagia.

    Baseline, 12 months

Secondary Outcomes (1)

  • Correlation of the presence of hiatal hernias

    Day 1

Study Arms (3)

Crura Dissection

EXPERIMENTAL

Participants with a visually detectable hiatal hernia at the time of sleeve gastrectomy procedure will undergo a crura dissection and hiatal hernia repair.

Procedure: Crura dissectionProcedure: Sleeve gastrectomyProcedure: Hiatal hernia repair

National Practice

EXPERIMENTAL

Participants with no detectable hiatal hernia will be randomized to either Group 2 or 3. Group 2 participants will be treated to the national practice patterns of complete dissection of the curvature of the stomach without dissection of the crura.

Procedure: Sleeve gastrectomy

Standard of Care

EXPERIMENTAL

Participants with no detectable hiatal hernia will be randomized to either Group 2 or 3. Group 3 participants will undergo the institutional standard of care with the dissection of the crura.

Procedure: Crura dissectionProcedure: Sleeve gastrectomy

Interventions

Crura dissectionPROCEDURE

The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy.

Crura DissectionStandard of Care
Sleeve gastrectomyPROCEDURE

Surgical weight-loss procedure in which 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.

Crura DissectionNational PracticeStandard of Care
Hiatal hernia repairPROCEDURE

This involves tightening the opening in your diaphragm with stitches to keep your stomach from bulging upward through the opening in the muscle wall.

Crura Dissection

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing primary sleeve gastrectomy at the University of Miami Division of Bariatric surgery
  • Age between 18-69 years
  • Able to provide consent

You may not qualify if:

  • History of anti-reflux procedure
  • History of foregut surgery
  • Narcotic dependence
  • History of gastroparesis
  • Special/vulnerable populations such as minors, patients unable to consent, pregnant women, and prisoners will not be included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Medical Campus

Miami, Florida, 33136, United States

Location

Study Officials

  • Nestor De La Cruz-Munoz, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 19, 2019

Study Start

November 22, 2019

Primary Completion

May 28, 2025

Study Completion

May 28, 2025

Last Updated

June 3, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)