Comparative Analysis of Postoperative Manometry Outcomes in Nissen vs Toupet Fundoplication

NCT06986902 | Completed DMC

• 1 other identifier: No. IRB00006379
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

GERD - Gastro-Esophageal Reflux Disease

Outcome Measures

Primary Outcomes (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

  6 Weeks Postoperative

Other Outcomes (5)

• Distal Contractile Integral (DCI)

  6 Weeks Postoperative

• Integrated Relaxation Pressure over 4 seconds (IRP-4s)

  6 Weeks Postoperative

• Distal Latency

  6 Weeks Postoperative

Study Arms (2)

N GROUP

EXPERIMENTAL

Patients undergoing laparoscopic Nissen fundoplication (LNF), which involves a 360° total wrap of the gastric fundus around the esophagus.

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.

Procedure: Laparoscopic Toupet fundoplication

Interventions

Laparoscopic Nissen Fundoplication PROCEDURE

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

N GROUP

Laparoscopic Toupet fundoplication PROCEDURE

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

T group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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)..

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt, 11111, Egypt

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Edward A Gadalla, MS

  Assistant lecturer in General surgery Department , Ain shams University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: May 23, 2025
• Study Start: March 10, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)