NCT00872755

Brief Summary

Laparoscopic Nissen Fundoplication has established itself as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease (GERD). Postoperative paraesophageal herniation has incidence ranges up to 7% in the immediate postoperative period. This randomized controlled study was scheduled to investigate the role of the posterior gastropexy, in combination with laparoscopic Nissen fundoplication, in prevention of paraesophageal herniation and improvement of postoperative results, in surgical treatment of GERD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

January 1, 2002

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
Last Updated

March 31, 2009

Status Verified

March 1, 2009

Enrollment Period

6.3 years

First QC Date

March 30, 2009

Last Update Submit

March 30, 2009

Conditions

Gastroesophageal Reflux DiseaseHiatal HerniaBarrett's EsophagusEsophagitisDysphagia

Outcome Measures

Primary Outcomes (1)

  • Laparoscopic Nissen fundoplication combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD

    9-94 months postoperatively

Study Arms (2)

Nissen

ACTIVE COMPARATOR

Laparoscopic Nissen Fundoplication

Procedure: Nissen

Gastropexy

ACTIVE COMPARATOR

Procedure/Surgery Laparoscopic Nissen Fundoplication combined with posterior gastropexy

Procedure: NissenProcedure: Gastropexy

Interventions

NissenPROCEDURE

Laparoscopic Nissen Fundoplication

GastropexyNissen
GastropexyPROCEDURE

posterior gastropexy

Gastropexy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Indications for surgical treatment of GERD
  • ASA I, II

You may not qualify if:

  • ASA III, IV
  • Previous gastric procedures
  • Conversion to open procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G. Hatzikosta General Hospital Department of Surgery

Ioannina, Epirus, 45001, Greece

Location

Related Publications (1)

  • Tsimogiannis KE, Pappas-Gogos GK, Benetatos N, Tsironis D, Farantos C, Tsimoyiannis EC. Laparoscopic Nissen fundoplication combined with posterior gastropexy in surgical treatment of GERD. Surg Endosc. 2010 Jun;24(6):1303-9. doi: 10.1007/s00464-009-0764-0. Epub 2009 Dec 4.

    PMID: 19960205DERIVED

MeSH Terms

Conditions

Gastroesophageal RefluxHernia, HiatalBarrett EsophagusEsophagitisDeglutition Disorders

Interventions

FundoplicationGastropexy

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPrecancerous ConditionsNeoplasmsGastroenteritisPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Evangelos C. Tsimoyiannis, M.D. chairman

    G. Hatzikosta General Hospital, Ioannina, Greece

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2009

First Posted

March 31, 2009

Study Start

January 1, 2002

Primary Completion

April 1, 2008

Study Completion

December 1, 2008

Last Updated

March 31, 2009

Record last verified: 2009-03

Locations

GR(1)