Crural Repair During Laparoscopic Sleeve Gastrectomy in Patients With a Lax Gastroesophageal Junction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorSengkang General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Unable or unwilling to provide informed consent
Contraindications to laparoscopic sleeve gastrectomy
Opted not to undergo laparoscopic sleeve gastrectomy
Had previous upper gastrointestinal surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Laparoscopic sleeve gastrectomy with concomitant hiatal hernia repair arm
Procedure/SurgerySurgical 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.
Laparoscopic sleeve gastrectomy arm
Procedure/SurgerySurgical 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.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Laparoscopic sleeve gastrectomy armActive comparator 1 intervention
Group B: Laparoscopic sleeve gastrectomy with hiatal hernia repair armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Presence or absence of post-operative erosive esophagitis
Presence or absence of erosive esophagitis on endoscopy
Time frame
1-year2
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)
Time frame
1-yearSecondary outcomes
1
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.
Time frame
3-month, 6-month, 9-month, 1-year2
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.
Time frame
3-month, 6-month, 9-month, 1-year3
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.
Time frame
3-month, 6-month, 9-month, 1-year4
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.
Time frame
3-month, 6-month, 9-month, 1-yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sengkang General Hospital
Lead sponsor
Singapore General Hospital
Collaborator
Source ClinicalTrials.gov