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

Primary Purpose

Obesity, Bariatric Surgery Candidate, Esophagus Injury

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Laparoscopic sleeve gastrectomy with concomitant hiatal hernia repair arm
Laparoscopic sleeve gastrectomy arm
Sponsored by
Sengkang General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Bariatric Surgery, Esophagitis, Gastroesophageal reflux disease, Laparoscopic sleeve gastrectomy

Eligibility Criteria

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

Inclusion Criteria:

  • 21-65 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Singapore General HospitalRecruiting
  • Sengkang General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Laparoscopic sleeve gastrectomy arm

Laparoscopic sleeve gastrectomy with hiatal hernia repair arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Presence or absence of post-operative erosive esophagitis
Presence or absence of erosive esophagitis on endoscopy
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)

Secondary Outcome Measures

General Quality of Life Scores
36-item Short Form Survey. It is a commonly employed questionnaire to assess overall quality of life. It comprises 36 short questions, which directly translates into a 0-100 scoring system. The higher the scores, the better the quality of life.
Gastroesophageal reflux disease symptoms
Gastrointestinal Symptom Rating Scale. It is a questionnaire assessing 5 different symptom clusters of gastrointestinal symptoms, namely Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. Each domain has a 7-point graded scale, where 1 represents no symptoms and 7 represents very troublesome symptoms. Hence, the higher the scores in a particular domain, the more troublesome the symptoms. In assessing the endpoint of gastroesophageal reflux disease symptoms, the domain of reflux in the GSRS questionnaire will be evaluated.
Dysphagia symptoms
Gastrointestinal Symptom Rating Scale. It is a questionnaire assessing 5 different symptom clusters of gastrointestinal symptoms, namely Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. Each domain has a 7-point graded scale, where 1 represents no symptoms and 7 represents very troublesome symptoms. Hence, the higher the scores in a particular domain, the more troublesome the symptoms. In assessing the endpoint of dysphagia symptoms as the secondary outcome, the domain of indigestion in the GSRS questionnaire will be evaluated.
Gastrointestinal reflux disease specific quality of life scores
Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD). The QOLRAD (reflux version) is a 25-item questionnaire specifically focusing on gastroesophageal reflux symptoms. It can be scored based on frequencies, from none of the time to all of the time, for each question. The higher the frequency, the more prevalent the symptoms.

Full Information

First Posted
March 27, 2022
Last Updated
April 10, 2022
Sponsor
Sengkang General Hospital
Collaborators
Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05330910
Brief Title
Crural Repair During Laparoscopic Sleeve Gastrectomy in Patients With a Lax Gastroesophageal Junction
Acronym
REPAIR
Official Title
A Randomized Controlled Trial Evaluating PAtients With Lax Gastroesophageal Junction to Initial Sleeve Gastrectomy With or Without Concomitant Crural Repair (REPAIR)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 30, 2027 (Anticipated)
Study Completion Date
April 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sengkang General Hospital
Collaborators
Singapore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Laparoscopic sleeve gastrectomy (LSG) is one of the most common bariatric procedures performed worldwide, accounting for more than 50% of all bariatric procedures, and with respectable weight loss and metabolic benefits which are comparable to the gold standard laparoscopic Roux-en-Y gastric bypass. However, one of the main disadvantages of LSG is its tendency to cause post-operative gastroesophageal reflux disease (GERD) and erosive esophagitis (EE). To date, it is widely accepted that LSG should be avoided for patients with underlying GERD or EE. However, there is no consensus for asymptomatic patients, including those with an underlying hiatal hernia, which is known to predispose to GERD. Currently, the two commonly employed methods for endoscopic classification of a hiatal hernia are via its axial length, or by grading the gastroesophageal flap valve, better known as the Hill's classification system. Multiple retrospective cohort studies have documented a reduction in postoperative GERD following a concomitant LSG with a hiatal hernia repair, in patients with a preoperative diagnosed hiatal hernia. However, to date, there is only one randomized controlled trial which compared the efficacy of concomitant LSG with or without a concomitant hiatal hernia repair. Of the 100 patients, the trial did not report any differences in the incidence of postoperative GERD between the 2 groups. However, the trial had several limitations. Firstly, it included patients with no underlying hiatal hernia. In fact, of the 100 patients, 25 of them have no underlying hiatal hernia, thus may favour the outcome towards the null hypothesis. Subsequently, though the study attempted to randomize participants, while most baseline characteristics are well randomized, the most crucial element in the study, which was the length of the hiatal hernia, was significantly different between the 2 groups. Thirdly, the primary outcome was a subjective score via the Gastrointestinal Symptom Rating Scale (GSRS). Lastly, assessment of the presence of a hiatal hernia via the axial length is known to be operator-dependent, as well as subject to changes between inspiration and expiration, which can make its assessment less objective. The investigators' propose using the alternative classification system for grading a hiatal hernia, called the Hill's classification system, to determine the preoperative hiatal laxity of the gastroesophageal flap valve, to determine which patients will likely benefit from a LSG with a concomitant hiatal hernia repair. The system, first introduced by Hill et al in 1996, was derived from an observational study of 13 cadavers to determine the presence of an anti-reflux valve and hiatal hernia. In the absence of a hiatal hernia, the angle of His, defined as the acute angulation along the greater curve of the stomach where the esophagus enters the stomach, creates a flap valve mechanism. This laxity of this flap valve varies and can be objectively graded based on the Hill's classification. This classification has been shown to be superior to the axial measurement of a hiatal hernia in the endoscopic assessment of the gastroesophageal junction and its association with GERD. The Hill's classification system is much more objective. The grade III gastroesophageal junction is easily and objectively assessed, with little inter-observer variability, by the presence of a failure of closure of the endoscope around the hiatus. Unlike patients with Hill's grade IV gastroesophageal junction with a frank hiatal hernia, these patients with a grade III gastroesophageal junction mainly have a lax junction, with at most a physiological (<3cm) hiatal hernia on axial length. Thus, this study proposes using the Hill's classification system to assess the efficacy of a concomitant crural repair with LSG in patients with a lax gastroesophageal flap valve. The investigators' hypothesize that a select group of patients with an underlying lax gastroesophageal junction may benefit from a concomitant crural repair with LSG. This group of patients, with grade III gastroesophageal junction, who have a lax hiatus and a small or physiological hiatal hernia, may potentially the only patient group that may benefit from a laparoscopic hiatal hernia or crural repair. Study design: 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). Study population: Eligible patients will come from patients visiting the bariatric surgery consultation clinic from both SKH and SGH. Patients that are deemed eligible for bariatric surgery will always undergo a routine esophagogastroduodenoscopy as part of standard preoperative evaluation. Patients found on esophagogastroduodenoscopy preoperatively to have a Hill's grade 3 gastroesophageal flap valve, with no evidence of EE will then be recruited. Included patients should be patients aged between 21-65 years old, able to provide informed consent, with Hill's grade III gastroesophageal junction, that have opted to undergo LSG. Excluded patients will include patients who are unable or unwilling to provide informed consent, with contraindications to LSG, who have opted not for LSG, who had previous upper gastrointestinal surgery, who have preoperative documented EE on endoscopy, who are graded Hill's grade I, II or IV gastroesophageal junction on retroflexion view of the endoscope with the stomach fully distended. Randomization: Patients will be blinded to their randomization allocation. Their allocation will only be made known should there be any adverse event, as per ethical guidelines, or after their end of 1-year follow-up. Outcome measures: Primary outcome measures will be presence of EE at the end of their 1-year follow-up after 1-year endoscopy. Secondary outcome measures will include any differences in SF-36 quality of life questionnaire, differences in their Gastrointestinal Symptom Rating Scale, as well as a Quality of Life in Reflux and Dyspepsia questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Bariatric Surgery Candidate, Esophagus Injury, Gastroesophageal Reflux
Keywords
Obesity, Bariatric Surgery, Esophagitis, Gastroesophageal reflux disease, Laparoscopic sleeve gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic sleeve gastrectomy arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Laparoscopic sleeve gastrectomy with hiatal hernia repair arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic sleeve gastrectomy with concomitant hiatal hernia repair arm
Other Intervention Name(s)
Laparoscopic sleeve gastrectomy with concomitant crural repair arm, Laparoscopic sleeve gastrectomy with concomitant cruroplasty arm
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic sleeve gastrectomy arm
Other Intervention Name(s)
Laparoscopic sleeve gastrectomy, Laparoscopic sleeve gastrectomy alone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence or absence of post-operative erosive esophagitis
Description
Presence or absence of erosive esophagitis on endoscopy
Time Frame
1-year
Title
Degree of Post-operative erosive esophagitis
Description
Grading of erosive esophagitis on endoscopy, noted as absent, or grade A, B, C or D (based on the Los Angeles classification)
Time Frame
1-year
Secondary Outcome Measure Information:
Title
General Quality of Life Scores
Description
36-item Short Form Survey. It is a commonly employed questionnaire to assess overall quality of life. It comprises 36 short questions, which directly translates into a 0-100 scoring system. The higher the scores, the better the quality of life.
Time Frame
3-month, 6-month, 9-month, 1-year
Title
Gastroesophageal reflux disease symptoms
Description
Gastrointestinal Symptom Rating Scale. It is a questionnaire assessing 5 different symptom clusters of gastrointestinal symptoms, namely Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. Each domain has a 7-point graded scale, where 1 represents no symptoms and 7 represents very troublesome symptoms. Hence, the higher the scores in a particular domain, the more troublesome the symptoms. In assessing the endpoint of gastroesophageal reflux disease symptoms, the domain of reflux in the GSRS questionnaire will be evaluated.
Time Frame
3-month, 6-month, 9-month, 1-year
Title
Dysphagia symptoms
Description
Gastrointestinal Symptom Rating Scale. It is a questionnaire assessing 5 different symptom clusters of gastrointestinal symptoms, namely Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. Each domain has a 7-point graded scale, where 1 represents no symptoms and 7 represents very troublesome symptoms. Hence, the higher the scores in a particular domain, the more troublesome the symptoms. In assessing the endpoint of dysphagia symptoms as the secondary outcome, the domain of indigestion in the GSRS questionnaire will be evaluated.
Time Frame
3-month, 6-month, 9-month, 1-year
Title
Gastrointestinal reflux disease specific quality of life scores
Description
Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD). The QOLRAD (reflux version) is a 25-item questionnaire specifically focusing on gastroesophageal reflux symptoms. It can be scored based on frequencies, from none of the time to all of the time, for each question. The higher the frequency, the more prevalent the symptoms.
Time Frame
3-month, 6-month, 9-month, 1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 21-65 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koy Min Chue, MBBS, FRCSEd
Phone
+65 91196091
Email
chuekoymin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baldwin Po Man Yeung, MBChB, FRCS
Organizational Affiliation
Sengkang General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeremy Tian Hui Tan, MBBS, FRACS
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Koy Min Chue, MBBS, FRCSEd
Organizational Affiliation
Sengkang General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
168753
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Tian Hui Tan, MBBS, FRACS
Facility Name
Sengkang General Hospital
City
Singapore
ZIP/Postal Code
544886
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koy Min Chue, MBBS, FRCSEd
Phone
+65 91196091
Email
chuekoymin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Unless there is Institutional Ethics Board approval and patient consent
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Crural Repair During Laparoscopic Sleeve Gastrectomy in Patients With a Lax Gastroesophageal Junction

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