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

NCT01780285 | Unknown Phase 3

• 1 other identifier: ONMU-2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hernia, Hiatal

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Anatomical and functional recurrence of hiatal hernia and GERD

  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.

  24 months

Secondary Outcomes (5)

• Repair-related dysphagia/oesophageal stricture/prosthetic erosion

  24 months

• Quality of life and satisfaction

  24 months

• Morbidity

  1 month

• Time to discharge

  1 month

• Number of participants completely recovered from extra-oesophageal complications of hiatal hernia following surgical procedure

  24 months

Study Arms (2)

Nitinol-framed PTFE mesh hiatal repair

ACTIVE COMPARATOR

Nitinol-framed lightweight PTFE mesh for hiatal repair

Device: Nitinol-framed lightweight PTFE mesh for hiatal repair

Lightweight mesh hiatal repair

ACTIVE COMPARATOR

Partially absorbable lightweight mesh for hiatal repair

Device: Partially absorbable lightweight mesh for hiatal repair

Interventions

Nitinol-framed lightweight PTFE mesh for hiatal repair DEVICE

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.

Also known as: Rebound HRD-Hiatus hernia

Nitinol-framed PTFE mesh hiatal repair

Partially absorbable lightweight mesh for hiatal repair DEVICE

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).

Also known as: Ultrapro

Lightweight mesh hiatal repair

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Odessa National Medical University: lead

Study Sites (1)

Department of surgery No. 1 of Odessa national medical university, Odessa regional hospital

Odesa, Ukaraine, 65025, Ukraine

Location

Related Publications (14)

• Draaisma WA, Gooszen HG, Tournoij E, Broeders IA. Controversies in paraesophageal hernia repair: a review of literature. Surg Endosc. 2005 Oct;19(10):1300-8. doi: 10.1007/s00464-004-2275-3. Epub 2005 Aug 4.

  PMID: 16151684 BACKGROUND

• Frantzides CT, Madan AK, Carlson MA, Stavropoulos GP. A prospective, randomized trial of laparoscopic polytetrafluoroethylene (PTFE) patch repair vs simple cruroplasty for large hiatal hernia. Arch Surg. 2002 Jun;137(6):649-52. doi: 10.1001/archsurg.137.6.649.

  PMID: 12049534 BACKGROUND

• Granderath FA, Schweiger UM, Kamolz T, Asche KU, Pointner R. Laparoscopic Nissen fundoplication with prosthetic hiatal closure reduces postoperative intrathoracic wrap herniation: preliminary results of a prospective randomized functional and clinical study. Arch Surg. 2005 Jan;140(1):40-8. doi: 10.1001/archsurg.140.1.40.

  PMID: 15655204 BACKGROUND

• Grubnik VV, Malinovskii AV. [Analysis of long-term results of laparoscopic repair of hiatal hernias and Nissen fundoplication]. Klin Khir. 2012 Oct;(10):34-6. No abstract available. Russian.

  PMID: 23272622 BACKGROUND

• Oelschlager BK, Pellegrini CA, Hunter JG, Brunt ML, Soper NJ, Sheppard BC, Polissar NL, Neradilek MB, Mitsumori LM, Rohrmann CA, Swanstrom LL. Biologic prosthesis to prevent recurrence after laparoscopic paraesophageal hernia repair: long-term follow-up from a multicenter, prospective, randomized trial. J Am Coll Surg. 2011 Oct;213(4):461-8. doi: 10.1016/j.jamcollsurg.2011.05.017. Epub 2011 Jun 29.

  PMID: 21715189 BACKGROUND

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

  BACKGROUND

• Champion JK, Rock D. Laparoscopic mesh cruroplasty for large paraesophageal hernias. Surg Endosc. 2003 Apr;17(4):551-3. doi: 10.1007/s00464-002-8817-7. Epub 2003 Feb 17.

  PMID: 12582773 BACKGROUND

• Frantzides CT, Carlson MA, Loizides S, Papafili A, Luu M, Roberts J, Zeni T, Frantzides A. Hiatal hernia repair with mesh: a survey of SAGES members. Surg Endosc. 2010 May;24(5):1017-24. doi: 10.1007/s00464-009-0718-6. Epub 2009 Dec 8.

  PMID: 19997755 BACKGROUND

• Granderath FA, Schweiger UM, Pointner R. Laparoscopic antireflux surgery: tailoring the hiatal closure to the size of hiatal surface area. Surg Endosc. 2007 Apr;21(4):542-8. doi: 10.1007/s00464-006-9041-7. Epub 2006 Nov 14.

  PMID: 17103275 BACKGROUND

• Johnson JM, Carbonell AM, Carmody BJ, Jamal MK, Maher JW, Kellum JM, DeMaria EJ. Laparoscopic mesh hiatoplasty for paraesophageal hernias and fundoplications: a critical analysis of the available literature. Surg Endosc. 2006 Mar;20(3):362-6. doi: 10.1007/s00464-005-0357-5. Epub 2006 Jan 25.

  PMID: 16437267 BACKGROUND

• Nguyen NT, Christie C, Masoomi H, Matin T, Laugenour K, Hohmann S. Utilization and outcomes of laparoscopic versus open paraesophageal hernia repair. Am Surg. 2011 Oct;77(10):1353-7.

  PMID: 22127087 BACKGROUND

• Rathore MA, Andrabi SI, Bhatti MI, Najfi SM, McMurray A. Metaanalysis of recurrence after laparoscopic repair of paraesophageal hernia. JSLS. 2007 Oct-Dec;11(4):456-60.

  PMID: 18237510 BACKGROUND

• Targarona EM, Bendahan G, Balague C, Garriga J, Trias M. Mesh in the hiatus: a controversial issue. Arch Surg. 2004 Dec;139(12):1286-96; discussion 1296. doi: 10.1001/archsurg.139.12.1286.

  PMID: 15611451 BACKGROUND

• Grubnik VV, Malynovskyy AV. Laparoscopic repair of hiatal hernias: new classification supported by long-term results. Surg Endosc. 2013 Nov;27(11):4337-46. doi: 10.1007/s00464-013-3069-2. Epub 2013 Jul 23.

  PMID: 23877759 BACKGROUND

MeSH Terms

Conditions

Hernia, Hiatal; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Volodymyr V. Grubnik, Prof., MD

  Department of surgery No. 1 of Odessa national medical university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant of department of surgery No. 1

Study Record Dates

• First Submitted: January 26, 2013
• First Posted: January 31, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2017
• Last Updated: June 30, 2016

Record last verified: 2016-06

Locations

UA (1)