Clinical trial · Interventional

ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

JUSTIFICATION OF THE PRINCIPLES OF ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

NCT04633382CI-TRIAL-00048370unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The aim of the study is to improve the immediate results after reconstructive and restorative operations on the biliary tract by substantiating the management of the perioperative period on the principles of "enhanced recovery after surgery".

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Biliary Stricture	—	UNRESOLVED	—
Cholangiocarcinoma	Cholangiocarcinoma	ONTOLOGY_EXACT	0.98
Cholangitis; Choledocholithiasis	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Enhanced recovery after biliary tract surgery	Combination Product	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Conducting research of enhanced recovery after surgery
description
1. Informing the patient about the course of the operation and the postoperative period. Psychological preparation. 2. Refusal from complete starvation. Carbohydrate drink 2 hours before surgery. 3. Refusal of cleansing enemas. 4. Refusal of premedication. NSAIDs 30 minutes before surgery 5. Prevention of thromboembolic complications 6. Multimodal analgesia: epidural catheter, paracetamol. 7. Minimally invasive access. 8. Prevention of hypothermia 9. Targeted infusion therapy. 10. Failure or limited time use of drainages: gastric, intra-abdominal, bile duct drainage. 11. Early activation of the patient. 12. Early enteral nutrition. 13. Prevention of nausea and vomiting.
interventionNames
1. Combination Product: Enhanced recovery after biliary tract surgery
type
PLACEBO_COMPARATOR
label
Conducting research of traditional recovery after surgery
description
1. Informing the patient about the course of the operation and the postoperative period. Psychological preparation. 2. Fasting for 2 days 3. Use of cleansing enemas. Bowel preparation 4. Premedication 5. Prevention of thromboembolic complications 6. Without multimodal analgesia 7. Traditional access. 8. Prevention of hypothermia 9. Targeted infusion therapy. 10. Use of drains: gastric, intra-abdominal, bile duct drainage. 11. Activation of patients within 2 days. 12. Enteral nutrition after 2 days after surgery. 13. Without the use of metoclopramide

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

Inclusion Criteria:

1. Patients with malignant diseases of the biliary tract (cholangiocarcinoma):

   1.1. tumor resectability 1.2. absence:
   * distant metastases
   * carcinomatosis
   * perforation of the tumor and peritonitis
   * sprouting into adjacent organs and tissues (locally advanced cancer)
   * total adhesion process in the abdominal cavity (after previous operations). 1.3. Planned reconstructive surgery on the biliary tract.
2. Patients with benign biliary tract pathology. 2.1. Planned reconstructive or restorative surgery on the biliary tract for the following diseases:

   * choledocholithiasis
   * Mirizzi syndrome
   * cysts of the common bile duct
   * strictures of the common bile duct
   * injuries to the bile ducts
   * adenoma and stricture of the OBD

Exclusion Criteria:

1. Scale ASA\> III (severe concomitant cardiovascular pathology).
2. Palliative reconstructive surgery.
3. Previously performed operations on the bile ducts (up to 1 month).
4. Cachexia.

References

Publications (0)

Data not yet available

No reference posted for this study.