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GERD - Gastro-Esophageal Reflux DiseaseNCT06986902

Comparative Analysis of Postoperative Manometry Outcomes in Nissen vs Toupet Fundoplication

A study testing Laparoscopic Nissen Fundoplication and Laparoscopic Toupet fundoplication in people with GERD - Gastro-Esophageal Reflux Disease, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled trial investigates the effects of laparoscopic Nissen and Toupet fundoplication on postoperative esophageal manometry findings in patients with gastroesophageal reflux disease (GERD). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
GERD - Gastro-Esophageal Reflux Disease
What is being tested?
Laparoscopic Nissen Fundoplication and Laparoscopic Toupet fundoplication
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteEgypt
Study dates
10 Mar 2024to 15 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients between 18 and 65 years of age
  • Patients with pre-operable low LES pressure proven by High resolution manometry.
  • Patients refractory to medical therapy: Persistent symptoms after 12 weeks of maximal medical therapies, recurrence upon cessation of medications.
  • Patients who are non-compliance with medical therapies or inability to tolerate medical therapies .
  • Patients with esophageal motility more than 30%

Who cannot join

  • Patients with esophageal motility less than 30%.
  • Patent with morbidly obese (BMI more than 35 kg/m2),
  • Patients with recent upper abdominal surgery or severely shortened esophagus
  • Extremes of age less than 18 and more than 65.
  • Patients who are unfit for general anesthesia (ASAIII,IV or V)..

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain Shams University

    Cairo, Egypt, 11111

Other trials in Egypt

About this study

Official title: Comparative Study Between the Effect of Nissen Fundoplication and Toupet Fundoplication on Post Operative Manometry Findings A Randomized Control Trial Study

This randomized controlled trial investigates the effects of laparoscopic Nissen and Toupet fundoplication on postoperative esophageal manometry findings in patients with gastroesophageal reflux disease (GERD). The study, conducted at Ain Shams University Hospitals, involved 20 adult patients randomly assigned to undergo either procedure. Preoperative and postoperative high-resolution manometry (HRM) was used to assess lower esophageal sphincter (LES) pressure and esophageal motility.

Read the detailed description

Preoperative Setting:

Before surgery, all patients underwent a thorough clinical assessment to evaluate the severity of their GERD symptoms, history of medication use, and the presence of extra-esophageal manifestations such as chronic cough or aspiration. A comprehensive diagnostic workup was conducted, including upper gastrointestinal endoscopy to assess mucosal integrity, rule out Barrett's esophagus, and evaluate the presence of a hiatal hernia. A barium swallow study was performed to assess esophageal motility, reflux severity, and anatomical abnormalities. The cornerstone of preoperative evaluation was high-resolution manometry (HRM), which provided precise measurements of lower esophageal sphincter (LES) pressure, esophageal peristalsis, and overall esophagogastric junction function.

Patients were deemed eligible for the study if they were between 18 and 65 years old and had documented low LES pressure on HRM. Those with persistent GERD symptoms despite at least 12 weeks of maximal medical therapy, intolerance to medication, or a desire to avoid lifelong proton pump inhibitor (PPI) therapy were considered suitable candidates. To ensure adequate postoperative esophageal motility, only patients with at least 30% esophageal peristalsis were included. Patients with esophageal motility disorders (such as achalasia), morbid obesity (BMI >35 kg/m²), a history of upper abdominal surgery, or a severely shortened esophagus were excluded. Patients classified as ASA III, IV, or V were also excluded due to the increased surgical risks associated with poor general health.

Patients were required to fast for at least 6-8 hours before surgery to minimize aspiration risk. Routine preoperative laboratory investigations, including a complete blood count (CBC), coagulation profile, and liver and kidney function tests, were performed. All patients underwent a pre-anesthesia assessment to determine their fitness for general anesthesia. On the day of surgery, prophylactic intravenous antibiotics were administered.

Intraoperative Setting:

The surgery was performed laparoscopically under general anesthesia. Patients were positioned in the modified lithotomy position with a reverse Trendelenburg tilt (head-up) to improve surgical exposure of the esophagogastric junction. The abdominal area was sterilized using antiseptic solution, and a CO₂ pneumoperitoneum was established (typically 12-15 mmHg) to facilitate laparoscopic access. A total of five to six laparoscopic ports were placed, with a 10-mm umbilical port for the camera and 5-mm ports for instruments and liver retraction.

For Nissen fundoplication, the procedure included circumferential dissection of the esophagus (ensuring 2-3 cm intra-abdominal length), crural closure with non-absorbable sutures, and mobilization of the gastric fundus (with division of short gastric vessels as needed). A 360° wrap was constructed and secured with four to five interrupted sutures. A 60F esophageal bougie was introduced intraoperatively to prevent a tight wrap.

For Toupet fundoplication, esophageal mobilization and crural closure were performed similarly. A 270° posterior wrap was constructed by positioning the gastric fundus posteriorly around the esophagus. It was secured with two to three sutures anchoring it to the right crura, two to three sutures attaching it to the esophagus, and two sutures securing it to the left crura. No esophageal bougie was used.

After the wrap, the surgeon ensured adequate tension, confirmed hemostasis, inspected for injury, and closed the abdominal incisions. Patients were extubated once fully recovered from anesthesia.

Postoperative Setting:

Following surgery, patients were monitored in the post-anesthesia care unit (PACU). Pain was managed with intravenous analgesics (e.g., paracetamol, NSAIDs, or opioids). Antiemetics such as ondansetron or metoclopramide were administered. Early ambulation was encouraged to reduce risks of deep vein thrombosis (DVT) and pulmonary complications.

Postoperative dietary advancement was structured to support healing. On the first postoperative day, patients were started on clear liquids. Over the next week, they progressed to a full liquid diet, then to soft/puréed foods by weeks 2-4, and finally to solids after four weeks while avoiding carbonated or hard foods.

All patients underwent high-resolution manometry (HRM) at six weeks postoperatively to assess LES pressure and esophageal motility. Data were collected and prepared for later analysis in accordance with study protocols.

Being tested
Laparoscopic Nissen Fundoplication, Laparoscopic Toupet fundoplication
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic Nissen FundoplicationProcedure or surgery

    a 360° total wrap of the gastric fundus around the esophagus.

  • Laparoscopic Toupet fundoplicationProcedure or surgery

    a 270° posterior partial wrap of the gastric fundus around the esophagus.

Study groups in NCT06986902
Study groupRoleWhat they receive
N GROUPExperimentalPatients undergoing laparoscopic Nissen fundoplication (LNF), which involves a 360° total wrap of the gastric fundus around the esophagus.
Receives: Procedure: Laparoscopic Nissen Fundoplication
T groupExperimentalPatients undergoing laparoscopic Toupet fundoplication (LTF), which involves a 270° posterior partial wrap of the gastric fundus around the esophagus.
Receives: Procedure: Laparoscopic Toupet fundoplication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lower Esophageal Sphincter (LES) Resting Pressure

    LES resting pressure will be recorded using high-resolution manometry (HRM) at 6 weeks after surgery to quantify baseline LES tone restoration.

    Unit of Measurment : mm Hg

    Measured: 6 Weeks Postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2025
  2. Study start10 Mar 2024
  3. Primary completion15 Mar 2025
  4. Study completion15 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06986902
Sponsor's protocol ID
No. IRB00006379
Status last verified
Mar 2025
First submitted
6 Apr 2025
Last updated
23 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all data will be shared once study is completed

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic Nissen Fundoplication and Laparoscopic Toupet fundoplication in people with GERD - Gastro-Esophageal Reflux Disease, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lower Esophageal Sphincter (LES) Resting Pressure (time frame: 6 Weeks Postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.

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