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

Morbid Obesity Clinical Trial

Official title:

Laparoscopic Sleeve Gastrectomy With or Without Hiatal Hernia Repair in Morbidly Obese Patients: a Single-center Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03776669
• Other study ID #: 201810017RINB
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2019
• Est. completion date: December 17, 2024

Study information

• Verified date: January 2022
• Source: National Taiwan University Hospital
• Contact: PoChu Lee, MD
• Phone: 886972651953
• Email: pochu.leepochu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 17, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Hernia
• Hernia, Hiatal
• Hiatal Hernia
• Morbid Obesity
• Obesity, Morbid
• Sleeve Gastrectomy

Intervention

Procedure:
• Laparoscopic sleeve gastrectomy + Hiatal hernia repair
To evaluate the role of concomitant hiatal hernia repair in laparoscopic sleeve gastrectomy for morbidly obese patients.
• Laparoscopic sleeve gastrectomy alone
Current mainstay and standard surgical treatment for morbidly obese patients.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (17)

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. — View 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 1:57-65. doi: 10.1111/j.1365-2982.2011.01834.x. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Oor JE, Roks DJ, Ünlü Ç, 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. Review. — View 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. — View 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. — View 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. — View Citation

Soricelli E, Casella G, Rizzello M, Calì 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. — View Citation

Soricelli E, Iossa A, Casella G, Abbatini F, Calì 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. — View 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. — View 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. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	De novo reflux esophagitis	Los angles classification grade B/C/D reflux esophagitis diagnosed by esophagogastroduodenoscopy.	Within 12 months after surgery if symptomatic or at 12 months if asymptomatic.
Secondary	Impedance reflux	Impedance reflux after single swallow by high resolution impedance manometry	12 months after the surgery
Secondary	Esophagogastric junction (EGJ) resting pressure	Measured by high resolution impedance manometry	12 months after the surgery
Secondary	Lower esophageal sphincter (LES) length	Measured by high resolution impedance manometry	12 months after the surgery
Secondary	De novo or aggravating hiatal hernia	Diagnosed by high resolution impedance manometry or esophagogastroduodenoscopy.	12 months after the surgery (or within 12 months after surgery if symptomatic )
Secondary	GerdQ score	Questionnaire for gastroesophageal reflux symptoms	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.
Secondary	Post-operative complication	Defined as complication ? grade III Clavien-Dindo classification	Within 30 days of surgery
Secondary	Mesh-related complication	infection, allergic reaction, intestinal complication, fistula formation, seroma formation, hematoma, recurrence of tissue defect, dysphagia, esophageal erosion or perforation.	Within 12 months after surgery