NCT05851794

Brief Summary

Laparoscopic Nissen fundoplication (LNF) is a surgical intervention for gastroesophageal reflux disease (GERD); however, it can be followed by recurrent symptoms or complications that may affect patient satisfaction. Intraoperative endomanometric evaluation of esophagogastric competence and pressure, combined with LNF in patients with large sliding hiatus hernia (\>5cm) with severe GERD (DeMeester score \>100), is needed.This is a retrospective, multicenter, comparative study. Baseline characteristics, initial reflux symptoms, preoperative and postoperative antacid medication use, postoperative complications (dysphagia and gas bloat syndrome), recurrent symptoms, and satisfaction were collected from a prospective database. Outcomes measures were recurrent reflux symptoms, postoperative side-effects, and satisfaction with surgery. Quantitative data were compared between the studied groups using the independent t-test or Mann-Whitney U test for normally and non-normally distributed numerical variables, respectively

Trial Health

100
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Status
completed

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

Study Start

First participant enrolled

April 1, 2012

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

8 years

First QC Date

May 1, 2023

Last Update Submit

July 3, 2023

Conditions

GERD

Outcome Measures

Primary Outcomes (2)

  • DeMeester score (0-3)

    0 is best while 3 is worst

    3 years

  • dysphagia score(0-3)

    0 is best while 3 is worst

    3 years

Study Arms (2)

endomanometric laparoscopic Nissen fundoplication

ACTIVE COMPARATOR

use endomanometry and endoscope during laparoscopic Nissen fundoplication

Procedure: endomanometric guided LNF

laparoscopic Nissen fundoplication alone

ACTIVE COMPARATOR

laparoscopic Nissen fundoplication only

Procedure: laparoscopic Nissen fundoplication alone

Interventions

endomanometric guided LNFPROCEDURE

use of endomanometry during LNF

endomanometric laparoscopic Nissen fundoplication
laparoscopic Nissen fundoplication alonePROCEDURE

laparoscopic Nissen fundoplication alone

laparoscopic Nissen fundoplication alone

Eligibility Criteria

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

You may qualify if:

  • patients 18≥ years with large sliding hiatus hernia (\> 5 cm) with severe GERD patients (DeMeester score \>100)with typical symptoms and successful medical management (due to quality of life considerations, life-long need medication intake or cost) or patients with unresponsive or inadequate symptom control despite eight weeks of adequate medical therapy with or without extra-esophageal Atypical symptoms that are related to GERD(cough, Globus, or hoarseness) confirmed diagnosis by hypotensive lower esophageal sphincter confirmed by HRM and a positive pH/impedance test (based on DeMeester scores)
  • fitness and consenting for surgery
  • patients that completed three year follow up period,
  • with esophagitis

You may not qualify if:

  • \<18years,
  • pregnancy,
  • Patients unfit for surgery \[ comorbid condition like severe cardiac illness, chronic respiratory diseases, chronic renal failure, and bleeding disorder\],
  • Non cooperative or lost patients for regular follow up,
  • Patients who had undergone previous antireflux surgery or who required a concurrent abdominal procedure at the same time as fundoplication (eg, cholecystectomy), -
  • psychiatric disorders.
  • esophageal dysmotility,

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professour of general and laparoscopic surgery

Study Record Dates

First Submitted

May 1, 2023

First Posted

May 10, 2023

Study Start

April 1, 2012

Primary Completion

April 1, 2020

Study Completion

April 1, 2023

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share