Clinical trial NCT05132816: High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux
Official title: High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux: Does the Ineffective Preoperative Oesophageal Motility Change Postoperatively?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux
Esophageal Motility Disorders
Upper Gastrointestinal Disorder
Lead sponsor: Spital Limmattal Schlieren
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a combined retro- and prospective, monocentric study. All patients who underwent or are planned for laparoscopic partial fundoplication (180° anterior or 270° posterior) between 2020-2023 are assessed for preoperative ineffective esophageal motility (IEM).

The main hypothesis is, that preoperative oesophageal motility disorders, especially hypo-contractility or failed peristalsis, are caused by gastro-oesophageal reflux. Therefore, postoperative manometry after partial wrap fundoplication (270° posterior, 180° anterior) shows a decrease in comparison to preoperative motility disorders.

The primary objective of this study is to examine the postoperative esophageal motility in patients with known preoperative motility disorders.

Secondary endpoints are the presence of other oesophageal motility disorders pre- vs. postoperatively (including new onset disorders), the assessment of the Gastrointestinal Symptom Rating Scale (GSRS) pre- vs. postoperatively, and more.

If IEM is present preoperatively, patients are contacted at least 1 year after surgery and will be informed about the study and asked to participate. In case of agreement, they are invited to the study site. They undergo high-resolution manometry 18-24 months postoperatively (study intervention).


Eligibility criteria: Inclusion Criteria:

* Age older than 18 years
* Ineffective esophageal motility disorder according the Chicago classification (7), defined as ≥ 7/10 (70%) of swallows with weak contraction (distal contraction interval (DCI) between 100mmHg/s/cm and less than 450 mmHg/s/cm) or ≥ 5/10 (50%) of swallows with failed peristalsis (DCI \<100mgHg/s/cm)Performance of partial fundoplication (180° anterior or 270° posterior) at Spital Limmattal
* Informed Consent as documented by signature

Exclusion Criteria:

* Age under 18 years
* Pregnancy
* Normal preoperative esophageal motility
* Other specifically defined esophageal motility disorders such as Nutcracker or Jackhammer esophagus
* Preoperative presence of a hiatal hernia with migration of \>20% of stomach in the chest
* Revisional surgery (after other procedures for reflux or at the hiatus)

Primary outcomes:
measure: Incidence of persistent postoperative IEM
timeFrame: 1-2 years postoperatively
Secondary outcomes:
measure: Presence of other oesophageal motility disorders
timeFrame: 1-2 years postoperatively
measure: GSRS
timeFrame: 1-2 years postoperatively
Other outcomes:
Locations:
city: Schlieren
country: Switzerland
facility: Spital Limmattal
state: ZH
Study officials:
References: