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Laparoscopic Lightweight Mesh Repair of Large Hiatal Hernias (LARGE)

This study is currently recruiting participants.
Verified January 2013 by Odessa National Medical University
Sponsor:
Information provided by (Responsible Party):
Dr. Andriy V. Malynovskyy, Odessa National Medical University
ClinicalTrials.gov Identifier:
NCT01408108
First received: August 1, 2011
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

This study is prospective randomized trial enrolling at least 100 participants which compares efficacy and safety of two alternative methods of laparoscopic hiatal repair for large (i.e. with hiatal surface area (HSA) ranging from 10 to 20 sq.cm, which corresponds to diameter of defect from 5 to 8 cm) types I, II, and III hiatal hernias: primary crural repair and repair with partially absorbable lightweight mesh. According to the literature, rates of anatomical failure and recurrence of GERD after primary repair of large hiatal hernias reach 42 %. Mesh repair decreases rates of failures, however, polypropylene and composite PTFE meshes used most widely, result in unacceptable rates of long-term dysphagia and oesophageal strictures. Our own experience of more than 400 repairs using partially absorbable lightweight mesh Ultrapro (Ethicon) and original sub-lay technique of its fixation precluding contact of the mesh with the oesophagus, showed low recurrence rate and a few cases of long-term dysphagia. Thus, final conclusions could be established by prospective randomized study. Our hypothesis is: original technique of lightweight mesh repair is highly effective for prevention of recurrences compared to primary repair and safe in terms of mesh-related dysphagia and oesophageal strictures. The long-term results (24 months post surgery for every patient) will be studied using symptom questionnaires, quality of life and satisfaction questionnaires, barium studies, endoscopic examinations, 24-hour pH testing, and analysis of possible reoperations.


Condition Intervention Phase
Hernia, Hiatal
 Procedure: Laparoscopic hiatal repair with sub-lay partially absorbable lightweight mesh
Procedure: Laparoscopic primary posterior crural repair
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Phase III Study of Laparoscopic Lightweight Mesh Repair of Large Hiatal Hernias

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odessa National Medical University:

Primary Outcome Measures:
  • Anatomical and functional recurrence of hiatal hernia and GERD [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Recurrence of hiatal hernia, i.e. anatomical recurrence, will be assessed by symptom questionnaire with visual analogue scales, MAINLY by barium study, and data from possible redo procedures. Recurrence of GERD, i.e. functional recurrence, will be evaluated by symptom questionnaire with visual analogue scales, endoscopic examination with assessment of degree of reflux-oesophagitis according to Los-Angeles classification, and 24 hour pH-testing with calculation of DeMeester score.


Secondary Outcome Measures:
  • Repair-related dysphagia/oesophageal stricture/prosthetic erosion [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Short- and long-term dysphagia, including due to repair-related oesophageal stricture, will be assessed by symptom questionnaire with visual analogue scales, barium study, endoscopic examination, and data from possible redo procedures. Patients also will be endoscopically assessed for such rare complication as prosthetic erosion of oesophagus.

  • Quality of life and satisfaction [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Quality of life and satisfaction will be assessed by GERD-HRQL score

  • Operative time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Postoperative hospital stay [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Influence on extra-oesophageal complications [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Extra-oesophageal complications to be assessed are: asthma, COPD, laryngitis, angina, and arrhythmias


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lightweight mesh repair
Laparoscopic hiatal repair with sub-lay partially absorbable lightweight mesh
 Procedure: Laparoscopic hiatal repair with sub-lay partially absorbable lightweight mesh
A fashioned according to the dimensions of hernia defect partially absorbable lightweight mesh Ultrapro™ (Ethicon, Inc.) will be sutured to both crura with 3 to 5 interrupted non-absorbable (Ethibond™ 3-0 by Ethicon, Inc.) sutures (as tension-free repair). Subsequent 2 to 3 interrupted non-absorbable sutures will approximate crura to completely cover a mesh to preclude its contact with the esophagus (original "sandwich" sub-lay technique).
Other Names:
  • Laparoscopic mesh hiatoplasty
  • Laparoscopic mesh hiatal closure
Active Comparator: Primary crural repair
Laparoscopic primary posterior crural repair
 Procedure: Laparoscopic primary posterior crural repair

Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable (Ethibond™ 3-0 by Ethicon, Inc.) sutures.

In the both arms laparoscopic procedure will be done in a standard fashion: reduction of hernia with excision of hernia sac and mobilization of distal esophagus, exposure of borders of hiatal opening including crura posteriorly to esophagus, repair if hiatal hernia defect (30 Fr esophageal bougie is used), a short (2,5 - 3,5 cm) 360° fundoplication wrap (floppy-Nissen procedure) (30 Fr esophageal bougie is used).

Other Names:
  • Laparoscopic posterior crurorrhaphy
  • Laparoscopic posterior crural closure

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type I, II and III hiatal hernias, including complicated by GERD
  • Able to undergo elective laparoscopic hiatal hernia repair
  • Able to 24 months follow-up with office examinations
  • Hiatal surface area (HSA) measuring 10 to 20 sq.cm (by granderath et al, 2007) which correspond to the diameter of hernia defect measuring 5 to 8 cm (the distinct size is determined intraoperatively, those with smaller or larger diameter will be excluded from the study)

Exclusion Criteria:

  • Unable to undergo laparoscopic hiatal hernia repair due to: severe comorbidities (ASA III and more), previous major surgery with severe adhesions, etc.
  • Cases of conversion to open surgery
  • Age < 20 years and > 80 years
  • BMI < 16 and > 39 kg/m2
  • Pregnancy or plans for pregnancy within next 2 years (in females)
  • Uncorrectable coagulopathy and immunosuppression
  • Oesophageal motility disorders
  • Oesophageal peptic strictures
  • Oesophageal diverticula, other types (i.e. non-reflux) of chronic esophagitis, connective tissue disorders (e.g. scleroderma)
  • Oesophageal shortening (determined intraoperatively as inability to achieve intra-abdominal length of oesophagus at least 3 cm in spite of intramediastinal oesophageal mobilization)
  • Barrett's oesophagus
  • History of oesophageal/gastric/duodenal surgery including vagotomy
  • Relapsing course of ulcer disease/hyperacid gastritis including complicated by delayed gastric/duodenal emptying
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408108

Contacts
Contact: Andriy V. Malinovskyy, PhD +380663269040 avmalinovskiy@rambler.ru
Contact: Volodymyr V. Grubnik, Prof., MD +380503912196 algrub@te.net.ua

Locations
Ukraine
Department of surgery # 1 of Odessa national medical university, Odessa regional hospital Recruiting
Odessa, Ukraine, 65025
Contact: Andriy V. Malynovskyy, PhD     +380663269040     avmalinovskiy@rambler.ru    
Principal Investigator: Volodymyr V. Grubnik, Prof., MD            
Sub-Investigator: Andriy V. Malynovskyy, PhD            
Sponsors and Collaborators
Odessa National Medical University
Investigators
Principal Investigator: Volodymyr V. Grubnik, Prof., MD Department of surgery # 1 of Odessa national medical university
  More Information

Publications:
Champion JK, McKernan JB. Hiatal size and risk of recurrence after laparoscopic fundoplication [abstract]. Surg Endosc. 1998; 12:565-570.

Responsible Party: Dr. Andriy V. Malynovskyy, Assistant of department of surgery # 1, Odessa National Medical University
ClinicalTrials.gov Identifier: NCT01408108     History of Changes
Other Study ID Numbers: ONMU-1
Study First Received: August 1, 2011
Last Updated: January 14, 2013
Health Authority: Ukraine: Ministry of Health

Keywords provided by Odessa National Medical University:
Hiatal hernia
Gastro-oesophageal reflux disease
Laparoscopic hiatal repair
Laparoscopic anti-reflux surgery
Partially absorbable lightweight mesh

Additional relevant MeSH terms:
Hernia
Hernia, Hiatal
Hernia, Diaphragmatic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013