Comparison of Laparoscopic Nissen Fundoplication and Hill-Snow Repair for Hiatus Hernia With Endoscopic Evaluation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorMinia University

About this trial

The goal of this clinical trial is to compare the clinical efficacy and safety of laparoscopic Nissen fundoplication (LNF) versus laparoscopic Hill-Snow repair (LHS) in the management of patients with congenital hiatus hernia, to evaluate the role of upper gastrointestinal endoscopy in the preoperative diagnosis and planning \& to determine the utility of intraoperative endoscopy in guiding the surgical repair and ensuring its technical adequacy.

main questions are:

* which one of these techniques is safer with higher clinical efficacy represented by relief of GERD symptoms ? * does upper GI endoscopy have a role in preoperative stage regarding diagnosis of condition and planning of treatment ? * does upper GI endoscopy have a role in intraoperative stage regarding guiding the surgical repair and ensuring its adequacy ?

all participants will be randomly assigned in one of two groups:

* one group undergoing Laparoscopic Nissen Fundoplication * the other group undergoing Laparoscopic Hill-Snow repair

each participsant will have preopertive, intraoperative and postoperative upper GI endoscopy to assess objectively clinical efficacy of both techniques and to define the integral role of endoscopy in all three perioperative stages

Eligibility criteria

Qualifiers

Patients aged less than 18 years including both sexes with a confirmed diagnosis of congenital hiatus hernia

Diagnosis of hiatus hernia refractory to maximal medical therapy (PPI for ≥12 weeks) AND/OR presence of complications (e.g., erosive esophagitis, Barrett's esophagus, recurrent aspiration pneumonia, failure to thrive)

Objective evidence of pathological GERD on upper endoscopy e.g: erosive esophagitis, Barrett's esophagus.

Disqualifiers

Previous esophageal or gastric surgery

Contraindications to laparoscopy e.g: cardiopulmonary decompensated cases.

Trial design

Treatments tested in this trial

  • Laparoscopic Hill-Snow repair
  • Laparoscopic Nissen Fundoplication

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators