NCT03396796

Modified Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection

Modified Vagus Nerve-preserving Versus Conventional Laparoscopic Splenectomy and Azygoportal Disconnection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Yangzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to evaluate whether vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection is effective and safe, and to determine whether a reduction in the incidence of postoperative complications of the digestive system improves postoperative quality of life compared with conventional laparoscopic splenectomy and azygoportal disconnection.

Detailed description

After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline parameter will be recorded and the patient will be randomized into either interventional (vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection) or control (conventional laparoscopic splenectomy and azygoportal disconnection) group. From postoperative day 3, all patients will receive 100 mg oral aspirin enteric-coated tablets (Bayer, Leverkusen, Germany) once daily for 1 year, low-molecular-weight heparin (CS Bio, Hebei, China) subcutaneously (4.100 IU/day) for 5 days, and 25 mg of oral dipyridamole (Henan Furen, Henan, China) thrice daily for 3 months. At months 3, 9, and 12 after operation, electron gastroscopy examination for delayed gastric emptying will be done for all patients. Postoperative complications of the digestive system (including diarrhea, epigastric fullness, bloating, nausea, and vomiting), liver and renal function, and body weight will be recorded at the seventh day, months 1, 3, 6, 9, and 12 after operation. Then one year monitoring will be done in the both groups as per the primary or secondary outcome.

Conditions

• Cirrhosis
• Hypertension
• Splenectomy
• Laparoscopy

Interventions

Type	Name	Description
PROCEDURE	Vagus nerve-preserving group	The modified vagus nerve-preserving procedure was performed in the following order: (1) left gastroepiploic vein along greater curvature; (2) the posterior surface of stomach, including the posterior gastric veins; (3) the left lateral surface of the distal esophagus; (4) the left inferior phrenic veins; (5) the posterior surface of the distal esophagus;(6) the anterior surface of the distal esophagus; and (7) the right lateral surface of the distal esophagus. The hepatogastric ligament was conserved. the adherent junction between visceral peritoneum and the right crural diaphragm, and divided it into the lesser omental sac. The left gastric artery and vein and the posterior gastric veins were transected en bloc using a linear laparoscopic vascular stapler.

Timeline

• Start date: 2018-04-09
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-01-11
• Last updated: 2020-01-22

Locations

1 site across 1 country: China