NCT04652336

Brief Summary

The aim of this study is to investigate the effect of ligamentum teres cardiopexy on incidence of de Novo GERD.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Status
unknown

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 26, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

December 10, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

November 26, 2020

Last Update Submit

December 17, 2020

Conditions

GERD

Keywords

de Novo GERD

Outcome Measures

Primary Outcomes (1)

  • GERD

    Subjective (Gastroesophageal Reflux Disease questionnaires - GERD - Q) and objective (24 hour pH study) measurement of occurence of GERD will be done GERD - Q - Score 0-2 denotes no GERD. Score more than or equal to 3 indicates presence of GERD 24 hr pH study - Demeester score more than 14.7 is indicative of presence of GERD

    6 months

Study Arms (2)

LSG

ACTIVE COMPARATOR

This group will receive standard laparoscopic sleeve gastrectomy

Procedure: laparoscopic sleeve gastrectomy

LSG with LTC

EXPERIMENTAL

This group will receive LSG along with the novel LTC procedure

Procedure: ligamentum teres cardiopexy with sleeve gastrectomy

Interventions

laparoscopic sleeve gastrectomyPROCEDURE

Comparator arm - will receive standard laparoscopic sleeve gastrectomy

LSG
ligamentum teres cardiopexy with sleeve gastrectomyPROCEDURE

experimental arm - Ligamentum teres will be divided from umbilicus to up to umbilical fissure. The ligament will then be wrapped around lower esophagus and sutured.

LSG with LTC

Eligibility Criteria

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

You may qualify if:

  • candidate for bariatric surgery according to IFSO - APC guidelines
  • No evidence (objective and subjective) of GERD

You may not qualify if:

  • Presence of GERD either by history or by 24 hr pH study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

PRAKHAR GUPTA

CONTACT

+919582438389mailto.guptaprakhar@gmail.com

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
SPONSOR

Study Record Dates

First Submitted

November 26, 2020

First Posted

December 3, 2020

Study Start

December 10, 2020

Primary Completion

May 10, 2021

Study Completion

December 10, 2021

Last Updated

December 21, 2020

Record last verified: 2020-12