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.
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.
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.
- Conditions
- GERD - Gastro-Esophageal Reflux Disease
- 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 group | Role | What they receive |
|---|---|---|
| N GROUP | Experimental | Patients undergoing laparoscopic Nissen fundoplication (LNF), which involves a 360° total wrap of the gastric fundus around the esophagus. Receives: Procedure: Laparoscopic Nissen Fundoplication |
| T group | Experimental | Patients 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.
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.
- First posted23 May 2025
- Study start10 Mar 2024
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERD - Gastro-Esophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward A Gadalla, MS, Principal investigator, Assistant lecturer in General surgery Department , Ain shams University Hospitals
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
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Effect of Nissen Fundoplication and Toupet Fundoplication on Post Operative Manometry Findings A Randomized Control Trial Study
- ClinicalTrials.gov ID
- NCT06986902
- Acronym / sponsor ID
- No. IRB00006379
- Conditions
- GERD - Gastro-Esophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N GROUP | Experimental | Procedure: Laparoscopic Nissen FundoplicationPatients undergoing laparoscopic Nissen fundoplication (LNF), which involves a 360° total wrap of the gastric fundus around the esophagus. |
| T group | Experimental | Procedure: Laparoscopic Toupet fundoplicationPatients undergoing laparoscopic Toupet fundoplication (LTF), which involves a 270° posterior partial wrap of the gastric fundus around the esophagus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (5 listed)
- 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)..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Nissen Fundoplicationa 360° total wrap of the gastric fundus around the esophagus. | Procedure or surgery | N GROUP |
| Laparoscopic Toupet fundoplicationa 270° posterior partial wrap of the gastric fundus around the esophagus. | Procedure or surgery | T group |
Primary outcome
Lower Esophageal Sphincter (LES) Resting Pressure
Time frame: 6 Weeks Postoperative
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: Yes. all data will be shared once study is completed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward A Gadalla, MS principal investigator
Assistant lecturer in General surgery Department , Ain shams University Hospitals
1 site in 1 country: see every site and its status.
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.