Crural Repair During Laparoscopic Sleeve Gastrectomy in Patients With a Lax Gastroesophageal Junction

NCT05330910 | Recruiting DMC

• 1 other identifier: 2022/2028
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Laparoscopic sleeve gastrectomy (LSG) is one of the commonest bariatric procedures. However, it is associated with postoperative gastroesophageal reflux disease (GERD) and erosive esophagitis (EE). The investigators' preliminary study suggests that the incidence of postoperative GERD and EE appears to be correlated with the preoperative presence of a lax gastroesophageal flap valve and hiatal hernia. Hypothesis/ Aim: To investigate the impact of a concomitant hiatal hernia repair with LSG on the incidence of postoperative EE. Significance: For patients with pre-existing EE, most surgeons will recommend a laparoscopic Roux-en-Y gastric bypass (LRYGB) as their primary bariatric procedure. However, compared to LSG, LRYGB is a technically more demanding procedure with increased morbidity and long term nutritional deficiencies. For asymptomatic patients at risk of postoperative EE due to presence of a hiatal hernia, there is still no consensus on the most appropriate bariatric surgical option. A LSG with a concomitant hiatal hernia repair, if shown to reduce EE postoperatively, may help to expand the pool of patients suitable for LSG in the future. Methods: A two center, double-blinded, randomized controlled trial of all patients, undergoing LSG with a preoperative diagnosis of a Hill's grade III gastroesophageal junction, will be randomized to having a concomitant hiatal hernia repair (experimental arm) versus just LSG alone (control arm). Primary outcome measures include 1-year postoperative EE on endoscopy. Secondary outcome measures include postoperative morbidity, blood loss, quality of life and GERD symptoms at 1-year postoperatively.

Conditions

Obesity; Bariatric Surgery Candidate; Esophagus Injury; Gastroesophageal Reflux

Keywords

Obesity; Bariatric Surgery; Esophagitis; Gastroesophageal reflux disease; Laparoscopic sleeve gastrectomy

Outcome Measures

Primary Outcomes (2)

• Presence or absence of post-operative erosive esophagitis

  Presence or absence of erosive esophagitis on endoscopy

  1-year

• Degree of Post-operative erosive esophagitis

  Grading of erosive esophagitis on endoscopy, noted as absent, or grade A, B, C or D (based on the Los Angeles classification)

  1-year

Secondary Outcomes (4)

• General Quality of Life Scores

  3-month, 6-month, 9-month, 1-year

• Gastroesophageal reflux disease symptoms

  3-month, 6-month, 9-month, 1-year

• Dysphagia symptoms

  3-month, 6-month, 9-month, 1-year

• Gastrointestinal reflux disease specific quality of life scores

  3-month, 6-month, 9-month, 1-year

Study Arms (2)

Laparoscopic sleeve gastrectomy arm

ACTIVE COMPARATOR

Surgical technique will be standardized and will be performed by the study team. The bougie size for the LSG will be 40Fr, and a standard 5-port LSG will be performed. Standard protocolized postoperative recovery for all bariatric patients will be employed, including liquid diet with vitamins for the first 2 weeks postoperatively, followed by introduction of solid foods after.

Procedure: Laparoscopic sleeve gastrectomy arm

Laparoscopic sleeve gastrectomy with hiatal hernia repair arm

EXPERIMENTAL

Surgical technique will be standardized and will be performed by the study team. The bougie size for the LSG will be 40Fr, and a standard 5-port LSG will be performed. Standard protocolized postoperative recovery for all bariatric patients will be employed, including liquid diet with vitamins for the first 2 weeks postoperatively, followed by introduction of solid foods after. A hiatal dissection will also be performed during initial surgery, followed by a cruroplasty with Ethibon 0 sutures, in an interrupted manner.

Procedure: Laparoscopic sleeve gastrectomy with concomitant hiatal hernia repair arm

Interventions

Laparoscopic sleeve gastrectomy with concomitant hiatal hernia repair arm PROCEDURE

Surgical technique will be standardized and will be performed by the study team. The bougie size for the LSG will be 40Fr, and a standard 5-port LSG will be performed. Standard protocolized postoperative recovery for all bariatric patients will be employed, including liquid diet with vitamins for the first 2 weeks postoperatively, followed by introduction of solid foods after. A hiatal dissection will also be performed during initial surgery, followed by a cruroplasty with Ethibon 0 sutures, in an interrupted manner.

Also known as: Laparoscopic sleeve gastrectomy with concomitant crural repair arm, Laparoscopic sleeve gastrectomy with concomitant cruroplasty arm

Laparoscopic sleeve gastrectomy with hiatal hernia repair arm

Laparoscopic sleeve gastrectomy arm PROCEDURE

Surgical technique will be standardized and will be performed by the study team. The bougie size for the LSG will be 40Fr, and a standard 5-port LSG will be performed. Standard protocolized postoperative recovery for all bariatric patients will be employed, including liquid diet with vitamins for the first 2 weeks postoperatively, followed by introduction of solid foods after.

Also known as: Laparoscopic sleeve gastrectomy, Laparoscopic sleeve gastrectomy alone

Laparoscopic sleeve gastrectomy arm

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Able to provide informed consent
• Hill's grade III gastroesophageal junction on preoperative endoscopy
• Opted to undergo laparoscopic sleeve gastrectomy as their bariatric procedure

You may not qualify if:

• Unable or unwilling to provide informed consent
• Contraindications to laparoscopic sleeve gastrectomy
• Opted not to undergo laparoscopic sleeve gastrectomy
• Had previous upper gastrointestinal surgery
• Had documented erosive esophagitis on preoperative endoscopy
• Had Hill's grade I, II or IV gastroesophageal junction on preoperative endoscopy

Sponsors & Collaborators

• Sengkang General Hospital: lead
• Singapore General Hospital: collaborator

Study Sites (2)

Singapore General Hospital

Singapore, 168753, Singapore

RECRUITING

Sengkang General Hospital

Singapore, 544886, Singapore

RECRUITING

Related Publications (14)

• Berger ER, Huffman KM, Fraker T, Petrick AT, Brethauer SA, Hall BL, Ko CY, Morton JM. Prevalence and Risk Factors for Bariatric Surgery Readmissions: Findings From 130,007 Admissions in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. Ann Surg. 2018 Jan;267(1):122-131. doi: 10.1097/SLA.0000000000002079.

  PMID: 27849660 BACKGROUND

• Peterli R, Wolnerhanssen BK, Peters T, Vetter D, Kroll D, Borbely Y, Schultes B, Beglinger C, Drewe J, Schiesser M, Nett P, Bueter M. Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity: The SM-BOSS Randomized Clinical Trial. JAMA. 2018 Jan 16;319(3):255-265. doi: 10.1001/jama.2017.20897.

  PMID: 29340679 BACKGROUND

• Salminen P, Helmio M, Ovaska J, Juuti A, Leivonen M, Peromaa-Haavisto P, Hurme S, Soinio M, Nuutila P, Victorzon M. Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA. 2018 Jan 16;319(3):241-254. doi: 10.1001/jama.2017.20313.

  PMID: 29340676 BACKGROUND

• Yeung KTD, Penney N, Ashrafian L, Darzi A, Ashrafian H. Does Sleeve Gastrectomy Expose the Distal Esophagus to Severe Reflux?: A Systematic Review and Meta-analysis. Ann Surg. 2020 Feb;271(2):257-265. doi: 10.1097/SLA.0000000000003275.

  PMID: 30921053 BACKGROUND

• Assalia A, Gagner M, Nedelcu M, Ramos AC, Nocca D. Gastroesophageal Reflux and Laparoscopic Sleeve Gastrectomy: Results of the First International Consensus Conference. Obes Surg. 2020 Oct;30(10):3695-3705. doi: 10.1007/s11695-020-04749-0. Epub 2020 Jun 12.

  PMID: 32533520 BACKGROUND

• Sgouros SN, Mpakos D, Rodias M, Vassiliades K, Karakoidas C, Andrikopoulos E, Stefanidis G, Mantides A. Prevalence and axial length of hiatus hernia in patients, with nonerosive reflux disease: a prospective study. J Clin Gastroenterol. 2007 Oct;41(9):814-8. doi: 10.1097/01.mcg.0000225678.99346.65.

  PMID: 17881926 BACKGROUND

• Hansdotter I, Bjor O, Andreasson A, Agreus L, Hellstrom P, Forsberg A, Talley NJ, Vieth M, Wallner B. Hill classification is superior to the axial length of a hiatal hernia for assessment of the mechanical anti-reflux barrier at the gastroesophageal junction. Endosc Int Open. 2016 Mar;4(3):E311-7. doi: 10.1055/s-0042-101021. Epub 2016 Feb 10.

  PMID: 27004249 BACKGROUND

• Hill LD, Kozarek RA, Kraemer SJ, Aye RW, Mercer CD, Low DE, Pope CE 2nd. The gastroesophageal flap valve: in vitro and in vivo observations. Gastrointest Endosc. 1996 Nov;44(5):541-7. doi: 10.1016/s0016-5107(96)70006-8.

  PMID: 8934159 BACKGROUND

• 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.

  PMID: 25348434 BACKGROUND

• Snyder B, Wilson E, Wilson T, Mehta S, Bajwa K, Klein C. A randomized trial comparing reflux symptoms in sleeve gastrectomy patients with or without hiatal hernia repair. Surg Obes Relat Dis. 2016 Nov;12(9):1681-1688. doi: 10.1016/j.soard.2016.09.004. Epub 2016 Sep 14.

  PMID: 27989522 BACKGROUND

• Holloway RH. The anti-reflux barrier and mechanisms of gastro-oesophageal reflux. Baillieres Best Pract Res Clin Gastroenterol. 2000 Oct;14(5):681-99. doi: 10.1053/bega.2000.0118.

  PMID: 11003803 BACKGROUND

• Thor KB, Hill LD, Mercer DD, Kozarek RD. Reappraisal of the flap valve mechanism in the gastroesophageal junction. A study of a new valvuloplasty procedure in cadavers. Acta Chir Scand. 1987 Jan;153(1):25-8.

  PMID: 3577567 BACKGROUND

• Navarini D, Madalosso CAS, Tognon AP, Fornari F, Barao FR, Gurski RR. Predictive Factors of Gastroesophageal Reflux Disease in Bariatric Surgery: a Controlled Trial Comparing Sleeve Gastrectomy with Gastric Bypass. Obes Surg. 2020 Apr;30(4):1360-1367. doi: 10.1007/s11695-019-04286-5.

  PMID: 32030616 BACKGROUND

• Chue KM, Toh BC, Ong LWL, Kariyawasam GM, Wong WK, Lim CH, Tan JTH, Yeung BPM. Rationale and Trial Protocol for a Double-Blinded Randomized Controlled Trial to assess the Impact of a Concomitant Crural Repair during Laparoscopic Sleeve Gastrectomy in Patients with a Lax Gastroesophageal Junction without Frank Hiatal Hernia (REPAIR trial protocol). Eur Surg Res. 2024 Feb 27. doi: 10.1159/000538043. Online ahead of print.

  PMID: 38412840 DERIVED

MeSH Terms

Conditions

Obesity; Gastroesophageal Reflux; Esophagitis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

Study Officials

• Baldwin Po Man Yeung, MBChB, FRCS

  Sengkang General Hospital

  PRINCIPAL INVESTIGATOR

• Jeremy Tian Hui Tan, MBBS, FRACS

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

• Koy Min Chue, MBBS, FRCSEd

  Sengkang General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koy Min Chue, MBBS, FRCSEd

CONTACT

+65 91196091; chuekoymin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Allocation concealment will be achieved via a central computer-generated random assignment, that will only be made known to the surgeon after the patient is induced on table prior to surgery. Participants from both institutions (SKH, SGH) will be within the same pool for block randomization, to ensure allocation concealment. Access or knowledge about the sequence of the randomization, will not be made known to the PI, Co-Is or mentor, and is only held by protocol administrator. Patient will be blinded to the randomization, and will only be told of the group of allocation at the end of completion of the study, at 1-year, after their postoperative endoscopy at 1-year. Outcomes assessor for primary outcomes at 1-year endoscopy will also be blinded to the initial surgery that was performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Model Details: This study will be a double institution, double-blinded, randomized controlled trial, involving surgeons from the Upper Gastrointestinal and Bariatric Service, Department of General Surgery, Sengkang General Hospital (SKH) as well as the Department of Upper Gastrointestinal and Bariatric Surgery, Singapore General Hospital (SGH). Randomization will be performed by block randomization, with each block of 4. Block randomization was selected given the small study size, to ensure equal representation in both arms of the study.

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: April 15, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)