ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626001104347

Ethics application status

Approved

Date submitted

7/08/2026

Date registered

7/09/2026

Date last updated

7/09/2026

Date data sharing statement initially provided

7/09/2026

Type of registration

Retrospectively registered

Titles & IDs

Public title

The effect of revision surgery (hiatus hernia repair, alone or with gastric bypass) on reflux in adults who have reflux after weight-loss sleeve gastrectomy

Scientific title

Investigating the efficacy of revision surgery (hiatus hernia repair alone or with conversion to Roux-en-Y gastric bypass) in alleviating gastro-oesophageal reflux in adults with reflux following laparoscopic sleeve gastrectomy: a prospective non-randomised pilot study of oesophageal acid exposure and symptom scores

Additional trial identifiers [1]

UGIS-SLEEVEREFLUX-2024

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Gastro-oesophageal reflux disease following laparoscopic sleeve gastrectomy

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Surgery

Other surgery

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of the intervention or exposure

Participants are adults with gastro-oesophageal reflux following laparoscopic sleeve gastrectomy who undergo revision surgery as part of usual clinical care. Two revision approaches are used. For the purpose of this registration, the exposure group comprises participants undergoing laparoscopic hiatus hernia repair with conversion of the sleeve to a Roux-en-Y gastric bypass; the control group comprises participants undergoing laparoscopic hiatus hernia repair alone, described in the comparator field.

Exposure arm: laparoscopic hiatus hernia repair with crural closure, followed by conversion of the sleeve gastrectomy to a Roux-en-Y gastric bypass. This is performed under general anaesthesia as a single operative episode, typically lasting two to three hours, and is not repeated. There is no ongoing study intervention after the operation.

Allocation is not assigned by the study. The choice between the two approaches is made by the treating surgeon on clinical grounds, and all surgical and clinical care is delivered as usual care.

Oesophageal acid exposure is measured by ambulatory pH or pH-impedance monitoring before revision surgery and once between 3 and 12 months after revision surgery. Catheter-based studies are recorded over 24 hours; catheter-free (Bravo) wireless studies are recorded over 48 hours. Patient-reported symptom (Visick) scores are collected before surgery and at 3, 6 and 12 months and 3 years after surgery.

Intervention code [1]

Diagnosis / Prognosis

Description of the comparator or control

The control approach is laparoscopic hiatus hernia repair alone, with crural closure and without conversion of the sleeve. This is performed under general anaesthesia as a single operative episode, typically lasting one to two hours, and is not repeated. Participants in this group are followed with the same assessments and at the same timepoints as the exposure group.

The primary comparison is within-participant: each participant's oesophageal acid exposure (pH testing) and patient-reported symptom (Visick) scores after revision surgery are compared with their own pre-operative values. A secondary comparison is between the two revision approaches, hiatus hernia repair alone versus hiatus hernia repair with conversion to Roux-en-Y gastric bypass. There is no separate untreated control group.

Control group

Active

Outcomes

Primary outcome [1]

Change in oesophageal acid exposure

Timepoint [1]

Before revision surgery (baseline) and once within 3 to 12 months after revision surgery.

Primary outcome [2]

Change in reflux symptoms

Timepoint [2]

Before revision surgery (baseline) and at 3, 6 and 12 months and 3 years after revision surgery.

Primary outcome [3]

Complications of revision surgery

Timepoint [3]

From revision surgery until 3 years after surgery.

Secondary outcome [1]

Resumption of anti-reflux medication

Timepoint [1]

At 3, 6 and 12 months and 3 years after revision surgery.

Secondary outcome [2]

Severity of erosive oesophagitis at gastroscopy

Timepoint [2]

Before revision surgery (baseline) and once within 3 to 12 months after revision surgery (in participants who undergo endoscopy).

Secondary outcome [3]

Patient satisfaction with revision surgery

Timepoint [3]

At 3, 6 and 12 months and 3 years after revision surgery.

Eligibility

Key inclusion criteria

Adults aged 18 years or older with gastro-oesophageal reflux following laparoscopic sleeve gastrectomy (reflux symptoms by self-report plus at least one objective measure of reflux on diagnostic testing) who are undergoing revision surgery (hiatus hernia repair alone, or hiatus hernia repair with conversion to Roux-en-Y gastric bypass) by an upper gastrointestinal surgeon at the study site, and who are able to provide informed consent.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

Inability to provide informed consent; pregnancy or breastfeeding; a decision not to proceed with revision surgery; and inability to communicate in English sufficiently to complete the study questionnaires.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

This is a pilot study; a formal power calculation is not applicable as there is no existing published data on objective reflux measures in this specific cohort before and after revision surgery. A convenience sample of up to 192 participants was chosen as achievable within clinical practice volumes, with a minimum of approximately 10 participants per revision type. Pre-operative and post-operative data will be compared using paired-sample t-tests for continuous variables and McNemar's or Bowker's tests for paired categorical variables, with a two-sided p-value below 0.05 considered statistically significant; analyses will be performed in SPSS.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

6/06/2026

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

192

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

St George Private Hospital - Kogarah

Recruitment postcode(s) [1]

2217 - Kogarah

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Upper Gastrointestinal and Metabolic Research Foundation Ltd

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

A/Prof Michael Talbot, St George Private Hospital

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ramsay Health Care Human Research Ethics Committee A

Ethics committee address [1]

https://www.ramsayhealth.com.au/Ramsay-Research/Reseach-Ethics-at-Ramsay

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

29/09/2025

Ethics approval number [1]

2024/ETH/0089

Summary

Brief summary

Some people who have weight-loss (sleeve gastrectomy) surgery later develop troublesome acid reflux, and when medication does not control it surgeons can offer revision surgery: repairing a hiatus hernia on its own, or repairing it and converting the stomach to a gastric bypass. This study follows adults having this revision surgery as part of their usual care and measures whether their reflux improves. Before surgery and again afterwards we compare each patient's acid-reflux test results (pH monitoring) and their reflux symptom (Visick) scores, and we record any complications, whether anti-reflux medication is restarted, and satisfaction with surgery. There is no separate control group; each participant acts as their own comparison, and we also compare the two revision approaches. We expect revision surgery to reduce both acid exposure and symptoms, which will help patients and surgeons choose between the two revision options.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Michael Talbot

Address

Upper GI Surgery, St George Private Hospital, 1 South Street, Kogarah NSW 2217

Country

Australia

Phone

+61 2 9553 1120

Fax

[email protected]

Contact person for public queries

Name

Michael Talbot

Address

Upper GI Surgery, St George Private Hospital, 1 South Street, Kogarah NSW 2217

Country

Australia

Phone

+61 2 9553 1120

Fax

[email protected]

Contact person for scientific queries

Name

Michael Talbot

Address

Upper GI Surgery, St George Private Hospital, 1 South Street, Kogarah NSW 2217

Country

Australia

Phone

+61 2 9553 1120

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor

What individual participant data might be shared?

• De-identified individual participant data:
• Published results

What types of analyses could be done with individual participant data?

• Systematic reviews and meta-analyses
• Studies testing whether findings can be repeated or confirmed

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
No end date

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: Requests should be directed to the principal investigator and data custodian, A/Prof Michael Talbot, at [email protected].

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically