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Laparoscopic Sleeve Gastrectomy With or Without Hiatal Hernia Repair in Morbidly Obese Patients

Primary Purpose

Morbid Obesity, Hiatal Hernia, Gastroesophageal Reflux Disease

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Laparoscopic sleeve gastrectomy + Hiatal hernia repair
Laparoscopic sleeve gastrectomy alone
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Morbid obesity, Hiatal hernia, Gastroesophageal reflux disease, High resolution impedance manometry

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with:

    1. Body mass index (BMI) ≧ 35, or
    2. 30 ≦ BMI < 35, with inadequately controlled type 2 diabetes mellitus (T2DM) or metabolic syndrome, or
    3. T2DM with BMI ≧ 32.5, or
    4. T2DM with BMI between 27.5 and 32.5 not well controlled by medication, especially for those with major cardiovascular risk.
  • Age: 20 to 65 years old.
  • Hiatal hernia diagnosed by either:

    1. HRIM: defined as the distance between low esophageal sphincter (LES) and crural diaphragm (CD) equal to or greater than 2 cm. (LES-CD ≧ 2 cm)
    2. EGD: defined as the apparent separation between the squamocolumnar junction and the diaphragmatic impression is greater than 2 cm.

Exclusion Criteria:

  • Prior major gastrointestinal (GI) tract surgery.
  • Bleeding tendency.
  • American Society of Anesthesiologists physical status (ASA) ≧ class III.
  • Pregnancy or lactating women.
  • Allergy to contrast medium for CT scan.
  • Concomitantly untreated or uncontrolled endocrine disease.
  • Alcohol or drug abuse.
  • Mental, behavioral, and neurodevelopmental disorders.

    1. Patients who possess "National Health Insurance (NHI) Major Illness/Injury Certificate" for ICD-10-CM codes F01-F99. (ICD: International Classification of Diseases; CM: Clinical Modification)
    2. Patients who have been hospitalized in psychiatric ward in the recent one year.
  • Type IV hiatal hernia.
  • Moderate to severe reflux esophagitis (LA classification grade B/C/D) refractory to medical treatment.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

LSG alone

LSG + HHR

Arm Description

Intervention: laparoscopic sleeve gastrectomy alone. LSG will be performed laparoscopically via a 5-port technique. The greater omentum is dissected by using the 5-mm laparoscopic LigaSure or Harmonic from 4 cm proximal to the pyloric ring to the angle of His. Sleeve calibration is done by a 36-French bougie inserted along the lesser curvature. Then the stomach is transected with sequential firings of linear green, gold, and blue 60 mm staplers starting about 4 cm proximal to the pylorus and ending approximately 2 cm distal to the left of the esophagus. The staple-line of the remnant gastric tube is oversewn with 3-0 V-Loc to prevent leakage and hemorrhage.

Intervention: concomitant laparoscopic sleeve gastrectomy + hiatal hernia repair. The surgical detail of LSG is the same as described in "LSG alone" arm, and the surgical detail of HHR is described as below. The hiatus is approached from the right side of the EGJ, through the lesser omentum. The hiatal defect is repaired by 1-0 Surgilon interruptedly, and then a commercialized "U-shaped" Biodesign Hiatal Hernia Graft is placed to the EGJ to cover the posterior side but spare the anterior side of the hiatus. Care must be taken to avoid direct contact of mesh to the esophagus to avoid any unnecessary complication. After the mesh is appropriately placed and oriented, 2 ml of TISSEEL solution for sealant is applied all over the mesh for fixation.

Outcomes

Primary Outcome Measures

De novo reflux esophagitis
Los angles classification grade B/C/D reflux esophagitis diagnosed by esophagogastroduodenoscopy.

Secondary Outcome Measures

Impedance reflux
Impedance reflux after single swallow by high resolution impedance manometry
Esophagogastric junction (EGJ) resting pressure
Measured by high resolution impedance manometry
Lower esophageal sphincter (LES) length
Measured by high resolution impedance manometry
De novo or aggravating hiatal hernia
Diagnosed by high resolution impedance manometry or esophagogastroduodenoscopy.
GerdQ score
Questionnaire for gastroesophageal reflux symptoms
Post-operative complication
Defined as complication ≧ grade III Clavien-Dindo classification
Mesh-related complication
infection, allergic reaction, intestinal complication, fistula formation, seroma formation, hematoma, recurrence of tissue defect, dysphagia, esophageal erosion or perforation.

Full Information

First Posted
December 13, 2018
Last Updated
January 19, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03776669
Brief Title
Laparoscopic Sleeve Gastrectomy With or Without Hiatal Hernia Repair in Morbidly Obese Patients
Official Title
Laparoscopic Sleeve Gastrectomy With or Without Hiatal Hernia Repair in Morbidly Obese Patients: a Single-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2019 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Background: Obesity and hiatal hernia are both risk factors of gastroesophageal reflux disease (GERD), and the incidence of hiatal hernia is much higher in morbidly obese patients. Many believe that higher intra-abdominal pressure with higher esophagogastric junction (EGJ) pressure gradient in morbidly obese patients is the main mechanism accounting for the occurrence of GERD. Hiatal hernia, on the other hand, is associated with structure abnormality of EGJ. Sleeve gastrectomy (SG) has been becoming a standalone bariatric surgery for decades, and it has been proved to effectively induce long-term weight loss in morbidly obese patients. Some studies found morbidly obese patients benefited from resolution of GERD after SG, however, other studies had the opposite findings. Some morbidly obese patients had aggravating GERD or de novo GERD after SG. The mechanism is still unclear now. It might result from removal of fundus and sling muscular fibers of EGJ, increased intra-gastric pressure (IIGP), and hiatal hernia after surgery. High resolution impedance manometry (HRIM) is used to access esophageal and EGJ function objectively. Impedance reflux was more frequently observed in patients having gastroesophageal reflux (GER) symptoms after SG. In addition, previous studies also found decreased EGJ resting pressure, decreased length of lower esophageal sphincter (LES), and presence of hiatal hernia were associated with more GERD after SG. Objective: To evaluate the long-term EGJ function and GERD in morbidly obese patients with hiatal hernia receiving laparoscopic sleeve gastrectomy (LSG) with or without hiatal hernia repair (HHR).
Detailed Description
Patients and methods: A total of 70 patients will be recruited and randomized to two groups with a 1:1 allocation ratio. Patients in the control group receive LSG alone and in the experimental group receive LSG with HHR. All subjects should provide basic clinical and demographic information, be evaluated for GER symptoms using GerdQ score, sign informed consent, and complete preoperative abdominal computed tomography (CT) scan, esophagogastroduodenoscopy (EGD), and HRIM. Outpatient follow-up would be arranged 1 weeks after discharge, then 1 month, 3 months, 6 months, and 12 months after surgery. Weight change and GER symptoms will be evaluated at every outpatient visit. Abdominal CT scan, EGD, and HRIM will be performed 12 months after surgery. Expected results: Less reflux esophagitis, less impedance reflux episodes, lower incidence of hiatal hernia, higher EGJ resting pressure, and longer LES length should be observed in morbidly obese patients receiving LSG with HHR at 12-month follow-up, using EGD and HRIM as evaluation tools. Furthermore, lower GerdQ score should be observed in these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Hiatal Hernia, Gastroesophageal Reflux Disease, Sleeve Gastrectomy
Keywords
Morbid obesity, Hiatal hernia, Gastroesophageal reflux disease, High resolution impedance manometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LSG alone
Arm Type
Active Comparator
Arm Description
Intervention: laparoscopic sleeve gastrectomy alone. LSG will be performed laparoscopically via a 5-port technique. The greater omentum is dissected by using the 5-mm laparoscopic LigaSure or Harmonic from 4 cm proximal to the pyloric ring to the angle of His. Sleeve calibration is done by a 36-French bougie inserted along the lesser curvature. Then the stomach is transected with sequential firings of linear green, gold, and blue 60 mm staplers starting about 4 cm proximal to the pylorus and ending approximately 2 cm distal to the left of the esophagus. The staple-line of the remnant gastric tube is oversewn with 3-0 V-Loc to prevent leakage and hemorrhage.
Arm Title
LSG + HHR
Arm Type
Experimental
Arm Description
Intervention: concomitant laparoscopic sleeve gastrectomy + hiatal hernia repair. The surgical detail of LSG is the same as described in "LSG alone" arm, and the surgical detail of HHR is described as below. The hiatus is approached from the right side of the EGJ, through the lesser omentum. The hiatal defect is repaired by 1-0 Surgilon interruptedly, and then a commercialized "U-shaped" Biodesign Hiatal Hernia Graft is placed to the EGJ to cover the posterior side but spare the anterior side of the hiatus. Care must be taken to avoid direct contact of mesh to the esophagus to avoid any unnecessary complication. After the mesh is appropriately placed and oriented, 2 ml of TISSEEL solution for sealant is applied all over the mesh for fixation.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic sleeve gastrectomy + Hiatal hernia repair
Intervention Description
To evaluate the role of concomitant hiatal hernia repair in laparoscopic sleeve gastrectomy for morbidly obese patients.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic sleeve gastrectomy alone
Intervention Description
Current mainstay and standard surgical treatment for morbidly obese patients.
Primary Outcome Measure Information:
Title
De novo reflux esophagitis
Description
Los angles classification grade B/C/D reflux esophagitis diagnosed by esophagogastroduodenoscopy.
Time Frame
Within 12 months after surgery if symptomatic or at 12 months if asymptomatic.
Secondary Outcome Measure Information:
Title
Impedance reflux
Description
Impedance reflux after single swallow by high resolution impedance manometry
Time Frame
12 months after the surgery
Title
Esophagogastric junction (EGJ) resting pressure
Description
Measured by high resolution impedance manometry
Time Frame
12 months after the surgery
Title
Lower esophageal sphincter (LES) length
Description
Measured by high resolution impedance manometry
Time Frame
12 months after the surgery
Title
De novo or aggravating hiatal hernia
Description
Diagnosed by high resolution impedance manometry or esophagogastroduodenoscopy.
Time Frame
12 months after the surgery (or within 12 months after surgery if symptomatic )
Title
GerdQ score
Description
Questionnaire for gastroesophageal reflux symptoms
Time Frame
At 1 week (± 1 week) after discharge, then 1 month (± 2 weeks), 3 months (± 1 month), 6 months (± 1 month), and 12 months (± 1 month) after surgery.
Title
Post-operative complication
Description
Defined as complication ≧ grade III Clavien-Dindo classification
Time Frame
Within 30 days of surgery
Title
Mesh-related complication
Description
infection, allergic reaction, intestinal complication, fistula formation, seroma formation, hematoma, recurrence of tissue defect, dysphagia, esophageal erosion or perforation.
Time Frame
Within 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with: Body mass index (BMI) ≧ 35, or 30 ≦ BMI < 35, with inadequately controlled type 2 diabetes mellitus (T2DM) or metabolic syndrome, or T2DM with BMI ≧ 32.5, or T2DM with BMI between 27.5 and 32.5 not well controlled by medication, especially for those with major cardiovascular risk. Age: 20 to 65 years old. Hiatal hernia diagnosed by either: HRIM: defined as the distance between low esophageal sphincter (LES) and crural diaphragm (CD) equal to or greater than 2 cm. (LES-CD ≧ 2 cm) EGD: defined as the apparent separation between the squamocolumnar junction and the diaphragmatic impression is greater than 2 cm. Exclusion Criteria: Prior major gastrointestinal (GI) tract surgery. Bleeding tendency. American Society of Anesthesiologists physical status (ASA) ≧ class III. Pregnancy or lactating women. Allergy to contrast medium for CT scan. Concomitantly untreated or uncontrolled endocrine disease. Alcohol or drug abuse. Mental, behavioral, and neurodevelopmental disorders. Patients who possess "National Health Insurance (NHI) Major Illness/Injury Certificate" for ICD-10-CM codes F01-F99. (ICD: International Classification of Diseases; CM: Clinical Modification) Patients who have been hospitalized in psychiatric ward in the recent one year. Type IV hiatal hernia. Moderate to severe reflux esophagitis (LA classification grade B/C/D) refractory to medical treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PoChu Lee, MD
Phone
886972651953
Email
pochu.leepochu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PoChu Lee, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PoChu Lee, MD
Phone
886972651953
Email
pochu.leepochu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no individual patient data (IPD) sharing plan now.
Citations:
PubMed Identifier
23810611
Citation
Che F, Nguyen B, Cohen A, Nguyen NT. Prevalence of hiatal hernia in the morbidly obese. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):920-4. doi: 10.1016/j.soard.2013.03.013. Epub 2013 Apr 19.
Results Reference
background
PubMed Identifier
24355324
Citation
Santonicola A, Angrisani L, Cutolo P, Formisano G, Iovino P. The effect of laparoscopic sleeve gastrectomy with or without hiatal hernia repair on gastroesophageal reflux disease in obese patients. Surg Obes Relat Dis. 2014 Mar-Apr;10(2):250-5. doi: 10.1016/j.soard.2013.09.006. Epub 2013 Sep 20.
Results Reference
background
PubMed Identifier
22867558
Citation
Soricelli E, Iossa A, Casella G, Abbatini F, Cali B, Basso N. Sleeve gastrectomy and crural repair in obese patients with gastroesophageal reflux disease and/or hiatal hernia. Surg Obes Relat Dis. 2013 May-Jun;9(3):356-61. doi: 10.1016/j.soard.2012.06.003. Epub 2012 Jun 19.
Results Reference
background
PubMed Identifier
25348434
Citation
Mahawar KK, Carr WR, Jennings N, Balupuri S, Small PK. Simultaneous sleeve gastrectomy and hiatus hernia repair: a systematic review. Obes Surg. 2015 Jan;25(1):159-66. doi: 10.1007/s11695-014-1470-0.
Results Reference
background
PubMed Identifier
27440196
Citation
Crawford C, Gibbens K, Lomelin D, Krause C, Simorov A, Oleynikov D. Sleeve gastrectomy and anti-reflux procedures. Surg Endosc. 2017 Mar;31(3):1012-1021. doi: 10.1007/s00464-016-5092-6. Epub 2016 Jul 20.
Results Reference
background
PubMed Identifier
20013071
Citation
Braghetto I, Lanzarini E, Korn O, Valladares H, Molina JC, Henriquez A. Manometric changes of the lower esophageal sphincter after sleeve gastrectomy in obese patients. Obes Surg. 2010 Mar;20(3):357-62. doi: 10.1007/s11695-009-0040-3. Epub 2009 Dec 15.
Results Reference
background
PubMed Identifier
24500799
Citation
DuPree CE, Blair K, Steele SR, Martin MJ. Laparoscopic sleeve gastrectomy in patients with preexisting gastroesophageal reflux disease : a national analysis. JAMA Surg. 2014 Apr;149(4):328-34. doi: 10.1001/jamasurg.2013.4323.
Results Reference
background
PubMed Identifier
26341463
Citation
Oor JE, Roks DJ, Unlu C, Hazebroek EJ. Laparoscopic sleeve gastrectomy and gastroesophageal reflux disease: a systematic review and meta-analysis. Am J Surg. 2016 Jan;211(1):250-67. doi: 10.1016/j.amjsurg.2015.05.031. Epub 2015 Aug 14.
Results Reference
background
PubMed Identifier
20049652
Citation
Soricelli E, Casella G, Rizzello M, Cali B, Alessandri G, Basso N. Initial experience with laparoscopic crural closure in the management of hiatal hernia in obese patients undergoing sleeve gastrectomy. Obes Surg. 2010 Aug;20(8):1149-53. doi: 10.1007/s11695-009-0056-8. Epub 2010 Jan 5.
Results Reference
background
PubMed Identifier
26428202
Citation
Ruscio S, Abdelgawad M, Badiali D, Iorio O, Rizzello M, Cavallaro G, Severi C, Silecchia G. Simple versus reinforced cruroplasty in patients submitted to concomitant laparoscopic sleeve gastrectomy: prospective evaluation in a bariatric center of excellence. Surg Endosc. 2016 Jun;30(6):2374-81. doi: 10.1007/s00464-015-4487-0. Epub 2015 Oct 1.
Results Reference
background
PubMed Identifier
25990380
Citation
Samakar K, McKenzie TJ, Tavakkoli A, Vernon AH, Robinson MK, Shikora SA. The Effect of Laparoscopic Sleeve Gastrectomy with Concomitant Hiatal Hernia Repair on Gastroesophageal Reflux Disease in the Morbidly Obese. Obes Surg. 2016 Jan;26(1):61-6. doi: 10.1007/s11695-015-1737-0. Erratum In: Obes Surg. 2016 Jan;26(1):67.
Results Reference
background
PubMed Identifier
12960718
Citation
Tutuian R, Vela MF, Shay SS, Castell DO. Multichannel intraluminal impedance in esophageal function testing and gastroesophageal reflux monitoring. J Clin Gastroenterol. 2003 Sep;37(3):206-15. doi: 10.1097/00004836-200309000-00004.
Results Reference
background
PubMed Identifier
25469569
Citation
Kahrilas PJ, Bredenoord AJ, Fox M, Gyawali CP, Roman S, Smout AJ, Pandolfino JE; International High Resolution Manometry Working Group. The Chicago Classification of esophageal motility disorders, v3.0. Neurogastroenterol Motil. 2015 Feb;27(2):160-74. doi: 10.1111/nmo.12477. Epub 2014 Dec 3.
Results Reference
background
PubMed Identifier
15329186
Citation
Suter M, Dorta G, Giusti V, Calmes JM. Gastro-esophageal reflux and esophageal motility disorders in morbidly obese patients. Obes Surg. 2004 Aug;14(7):959-66. doi: 10.1381/0960892041719581.
Results Reference
background
PubMed Identifier
26956879
Citation
Mion F, Tolone S, Garros A, Savarino E, Pelascini E, Robert M, Poncet G, Valette PJ, Marjoux S, Docimo L, Roman S. High-resolution Impedance Manometry after Sleeve Gastrectomy: Increased Intragastric Pressure and Reflux are Frequent Events. Obes Surg. 2016 Oct;26(10):2449-56. doi: 10.1007/s11695-016-2127-y.
Results Reference
background
PubMed Identifier
19737151
Citation
Jones R, Junghard O, Dent J, Vakil N, Halling K, Wernersson B, Lind T. Development of the GerdQ, a tool for the diagnosis and management of gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1030-8. doi: 10.1111/j.1365-2036.2009.04142.x. Epub 2009 Sep 8.
Results Reference
background
PubMed Identifier
22248109
Citation
Bredenoord AJ, Fox M, Kahrilas PJ, Pandolfino JE, Schwizer W, Smout AJ; International High Resolution Manometry Working Group. Chicago classification criteria of esophageal motility disorders defined in high resolution esophageal pressure topography. Neurogastroenterol Motil. 2012 Mar;24 Suppl 1(Suppl 1):57-65. doi: 10.1111/j.1365-2982.2011.01834.x.
Results Reference
background

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Laparoscopic Sleeve Gastrectomy With or Without Hiatal Hernia Repair in Morbidly Obese Patients

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