Trial record 2 of 8 for:    Open Studies | "Hernia, Hiatal"

Laparoscopic Repair of Giant Hiatal Hernias With Nitinol-framed Lightweight Polytetrafluoroethylene Mesh (GIANT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Odessa National Medical University
Sponsor:
Information provided by (Responsible Party):
Dr. Andriy V. Malynovskyy, Odessa National Medical University
ClinicalTrials.gov Identifier:
NCT01780285
First received: January 26, 2013
Last updated: November 17, 2013
Last verified: November 2013
  Purpose

This study is prospective randomized trial enrolling at least 50 participants which compares efficacy and safety of two alternative methods of laparoscopic hiatal repair for giant (i.e. with hiatal surface area (HSA) exceeding 20 sq.cm) types II and III hiatal hernias: partially absorbable lightweight mesh repair, and nitinol-framed lightweight polytetrafluoroethylene (PTFE) mesh repair. In the literature, mean rate of anatomical recurrence of giant hiatal hernias is 25 %, reaching 42 %. Polypropylene and composite PTFE meshes used most widely, result in unacceptable rates of long-term dysphagia (10-15 %) and oesophageal strictures. Own experience of the interventors 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 for large hernias and a few cases of long-term dysphagia. For giant hiatal hernias, this technique provides acceptable results (20 % of recurrence) which correspond to the literature. Nevertheless, these results may be improved, probably by using of new type of prosthesis. Thus, in collaboration with Minnesota Medical Development, Inc., USA, the interventors created fundamentally new method of hiatal repair by using new prosthesis - Rebound HRD-Hiatus hernia. This prosthesis is heart-shaped lightweight PTFE mesh with peripheral nitinol frame. It is easily fixated to the crura posteriorly to the oesophagus completely covering hernia defect, and supports a strong framework of the hiatus, and, therefore, allows to save a principle a real tension-free repair. Mid-term results (mean follow-up period of 15 months) of 29 procedures showed no recurrences or oesophageal complications. Naturally, final conclusions regarding superiority of the new technique could be established by prospective randomized study. The hypothesis of the current trial is: new method of nitinol-framed lightweight PTFE mesh repair is more effective in terms of recurrence rate compared to sub-lay partially absorbable lightweight mesh repair, and is characterized by at least similar safety in terms of oesophageal complications. 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
Device: Nitinol-framed lightweight PTFE mesh for hiatal repair
Device: Partially absorbable lightweight mesh for hiatal 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 Repair of Giant Hiatal Hernias With Nitinol-framed Lightweight Polytetrafluoroethylene Mesh

Resource links provided by NLM:


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 ]
    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

  • Morbidity [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Time to discharge [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Time to discharge will be measured in days, from the day of primary surgical procedure, i.e. laparoscopic hiatal hernia repair, to the day of discharge from the hospital

  • Number of participants completely recovered from extra-oesophageal complications of hiatal hernia following surgical procedure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Extra-oesophageal complications of hiatal hernia to be assessed are: asthma, chronic obstructive pulmonary disease, laryngitis, angina, and arrhythmias


Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nitinol-framed PTFE mesh hiatal repair
Nitinol-framed lightweight PTFE mesh for hiatal repair
Device: Nitinol-framed lightweight PTFE mesh for hiatal repair
The heart-shaped nitinol-framed lightweight PTFE prosthesis "Rebound HRD-Hiatus hernia" (Minnesota Medical Development, Inc.) of small (4,0 x 4,5 cm) to large size (5,5 х 6,0 cm) is sutured to the crura posteriorly to oesophagus with 3 or 5 interrupted non-absorbable (Ethibond 3-0 by Ethicon, Inc.) sutures, thus performing complete tension-free hiatal repair.
Other Name: Rebound HRD-Hiatus hernia
Active Comparator: Lightweight mesh hiatal repair
Partially absorbable lightweight mesh for hiatal repair
Device: Partially absorbable lightweight mesh for hiatal repair

A fashioned according to the dimensions of hernia defect partially absorbable lightweight mesh Ultrapro (Ethicon, Inc.) will be sutured to both crura posteriorly to oesophagus 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).

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

Other Name: Ultrapro

  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 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) exceeding 20 sq.cm (by Granderath et al, 2007) which correspond to the diameter of hernia defect exceeding 8 cm (the distinct size is determined intraoperatively, those with smaller diameter will be excluded from the study),
  • Nissen fundoplication (intraoperative criterion)

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/sq.m
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780285

Contacts
Contact: Andriy V. Malinovskyy, PhD +380663269040 uamelt@gmail.com
Contact: Volodymyr V. Grubnik, Prof., MD +380503912196 algrub@te.net.ua

Locations
Ukraine
Department of surgery No. 1 of Odessa national medical university, Odessa regional hospital Recruiting
Odessa, Ukaraine, Ukraine, 65025
Contact: Grubnik V. Volodymyr, Prof., MD    +380503912196    algrub@te.net.ua   
Contact: Andriy V. Malinovskyy, PhD    +380663269040    uamelt@gmail.com   
Principal Investigator: Volodymyr V. Grubnik, Prof., MD         
Sub-Investigator: Andriy V. Malinovskyy, PhD         
Sponsors and Collaborators
Odessa National Medical University
Investigators
Principal Investigator: Volodymyr V. Grubnik, Prof., MD Department of surgery No. 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 No. 1, Odessa National Medical University
ClinicalTrials.gov Identifier: NCT01780285     History of Changes
Other Study ID Numbers: ONMU-2
Study First Received: January 26, 2013
Last Updated: November 17, 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
Polytetrafluoroethylene
PTFE
Nitinol
Nitinol-framed lightweight PTFE mesh

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

ClinicalTrials.gov processed this record on July 31, 2014