Laparoscopic Lightweight Mesh Repair of Large Hiatal Hernias

NCT01408108 | Unknown Phase 3

• 1 other identifier: ONMU-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hernia, Hiatal

Keywords

Hiatal hernia; Gastro-oesophageal reflux disease; Laparoscopic hiatal repair; Laparoscopic anti-reflux surgery; Partially absorbable lightweight 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 (6)

• Repair-related dysphagia/oesophageal stricture/prosthetic erosion

  24 months

• Quality of life and satisfaction

  24 months

• Operative time

  1 day

• Morbidity

  1 month

• Postoperative hospital stay

  1 month

Study Arms (2)

Lightweight mesh repair

ACTIVE COMPARATOR

Laparoscopic hiatal repair with sub-lay partially absorbable lightweight mesh

Procedure: Laparoscopic hiatal repair with sub-lay partially absorbable lightweight mesh

Primary crural repair

ACTIVE COMPARATOR

Laparoscopic primary posterior crural repair

Procedure: Laparoscopic primary posterior crural repair

Interventions

Laparoscopic hiatal repair with sub-lay partially absorbable lightweight mesh PROCEDURE

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).

Also known as: Laparoscopic mesh hiatoplasty, Laparoscopic mesh hiatal closure

Lightweight mesh repair

Laparoscopic primary posterior crural repair PROCEDURE

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).

Also known as: Laparoscopic posterior crurorrhaphy, Laparoscopic posterior crural closure

Primary crural 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 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)

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/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

Sponsors & Collaborators

• Odessa National Medical University: lead

Study Sites (1)

Department of surgery # 1 of Odessa national medical university, Odessa regional hospital

Odesa, 65025, Ukraine

Location

Related Publications (9)

• 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

• 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

• Hazebroek EJ, Ng A, Yong DH, Berry H, Leibman S, Smith GS. Evaluation of lightweight titanium-coated polypropylene mesh (TiMesh) for laparoscopic repair of large hiatal hernias. Surg Endosc. 2008 Nov;22(11):2428-32. doi: 10.1007/s00464-008-0070-2. Epub 2008 Jul 15.

  PMID: 18626699 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

• 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 # 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 # 1

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 3, 2011
• Study Start: January 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2016
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

UA (1)