Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-26 @ 11:10 AM
Ignite Modification Date: 2025-12-26 @ 11:10 AM
NCT ID: NCT04454112
Brief Summary: The aim of this study was to evaluate 24-hour pH monitoring results before and after gastrostomy in neurological impaired (NI) children who underwent gastrostomy or Nissen fundoplication (NF) concurrently with gastrostomy.
Detailed Description: Gastrointestinal (GI) problems causing malnutrition may develop quite frequently in patients with neuromotor developmental delay. Diagnosis of GERD in patients with neurological impairment (NI) might be more difficult due to the absence of characteristic features in many cases. One of the best methods for the diagnosis of GER is the 24-hour esophageal pH monitoring.Even though there are some statements in the literature advocating that gastroesophageal reflux may develop in the late period in patients undergoing only gastrostomy, there are also reports supporting that gastrostomy does not contribute to the development of reflux.Regardless of whether the patient received anti-reflux surgery or not, the long-term follow-up is necessary in patients feeding with gastrostomy.The aim of this study is to compare the results of pre- and postoperative 24-hour pH monitoring in patients who underwent gastrostomy only and who underwent fundoplication concurrently with gastrostomy and to evaluate influence of gastrostomy/ LNF+ gastrostomy on GER.
Study: NCT04454112
Study Brief:
Protocol Section: NCT04454112