Clinical trial NCT03659487: Comparison of Total and Partial Fundoplication During Surgery of Patients With Gastroesophageal Reflux Disease
Official title: Comparison of Total and Partial Fundoplication During Surgery of Patients With Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reflux, Gastroesophageal
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Laparoscopic total (Nissen) vs posterior 270 degrees (Toupét) partial fundoplication for the treatment of gastroesophageal reflux disease.
Primary purpose: TREATMENT

Brief summary: 460 patients who are scheduled for surgical treatment of gastroesophageal reflux disease (GERD) participate in the study following the usual preoperative Clinical routines (Medical history, endoscopy with biopsies, esophageal manometry with 24 hour pH (acidity) registration ). Patients are randomized to fundoplication according to Nissen or modified Toupet. Postoperatively, patients are monitored after 6 weeks 12, 36, 24 and 60 months.

Detailed description: Patients aged 18-75 years planned for elective surgical treatment of GERD participate in the study. Patients with recurrent reflux disease following prior surgery, ASA (American Society of Anesthesiologists (ASA) Physical Status") class\> 3, paraesophageal herniating and / or major herniation without reflux and those with other contraindications against laparoscopic surgery are excluded. In addition, patient completes a QOL protocol. Patients in the study are randomized to laparoscopic fundoplication performed either with a 360 degrees (Nissen) alternatively 270 degree (modified Toupét). Both of these techniques are well established clinical routines. General intubation anesthesia is standardized to all study patients. Discharge from the hospital is typically on the first postoperative day. At a visit, after 6-8 weeks for clinical control, is a QOL protocol is completed as well. After 12 and 36 months, patients undergo upper endoscopy and manometry with 24 hour pH-registration and QOL protocol completion. The latter also occurs after 24 months and 60 months.

Eligibility criteria: Inclusion Criteria:

* surgery treatment for GERD
* laparoscopic surgery

Exclusion Criteria:

* previous surgery for GERD
* ASA classification \>3
* paraesophageal hernias or large hiatal

Primary outcomes:
measure: Esophageal acid exposure
timeFrame: Change from baseline at 6 weeks, 12 and 36 month
Secondary outcomes:
measure: Recurrens rates
timeFrame: Change from baseline at 6 weeks, 12, 36 and 60 month
measure: Dysphagia scoring
timeFrame: Change from baseline at 6 weeks, 12, 36 and 60 month
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institut
name: Anders Thorell, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hakanson BS, Lundell L, Bylund A, Thorell A. Comparison of Laparoscopic 270 degrees Posterior Partial Fundoplication vs Total Fundoplication for the Treatment of Gastroesophageal Reflux Disease: A Randomized Clinical Trial. JAMA Surg. 2019 Jun 1;154(6):479-486. doi: 10.1001/jamasurg.2019.0047.