Skip to main content
OpenTrials
Completed

NCT Number: NCT06630767

Enhanced Recovery After Surgery Program Versus Conventional Care for Laparoscopic Common Bile Duct Exploration

Laparoscopic common bile duct exploration (LCBDE) is a minimally invasive procedure to treat common bile duct stones (CBDS). Perioperative anxiety, hunger, thirst, fatigue, pain, nausea, and vomiting can influence a patient's recovery after surgery and prolong the in-hospital stay. Enhanced Recovery After Surgery (ERAS) is a modern concept that aims to improve perioperative patient care by implementing an evidence-based, patient-centered team approach. However, few reports focused on the safety and efficacy of the ERAS program in LCBDE. Therefore, this paper aims to compare the outcome of the ERAS program and conventional (C) care for patients undergoing LCBDE

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Valley University, Luxor, Egypt

Loading trial locations.

About this study

All patients undergoing surgery prefer to stay at the hospital for a shorter period and resume work as early as possible. The post-operative recovery and rehabilitation are influenced by numerous surgical factors such as inadequate pain management and postoperative complications, and non-surgical factors such as anxiety and stress, reduced physical activity, and unintended prolonged fasting due to improper scheduling.

Carefully planned perioperative care is approved to shorten the rehabilitation period and accelerate the recovery by preserving preoperative organ function, reducing the depth of intraoperative stress reaction, and minimizing postoperative complications, through many parameters such as emotional support, pharmacological prophylaxis, wound anesthesia, PONV prophylaxis, low-pressure pneumoperitoneum, and restricted use of surgical drains and infusions contributing to medical and economic benefit in healthcare. Two techniques are believed to improve post-operative recovery and rehabilitation; the first is the minimally invasive surgery and the second is the enhanced recovery after surgery (ERAS) program.

Laparoscopic common bile duct exploration (LCBDE) is one of the recent minimally invasive maneuvers to treat common bile duct stones (CBDS) that may be combined with laparoscopic cholecystectomy for gallbladder stones as a one-stage procedure with the advantage of minor trauma and bleeding, low postoperative complication and pain, quick recovery, and shorter hospital stay. On the contrary, It has various complications due to pneumoperitoneum and positioning including changes in cardiac output and blood pressure, decreased lung volumes, basal atelectasis, increased intrapulmonary shunting, raised airway pressures, acute postoperative pain, and postoperative nausea and vomiting (PONV).

Enhanced recovery after surgery (ERAS) programs are a recent combination of evidenced-based perioperative care approaches that work synergistically to improve recovery after surgery. The underlying mechanism of ERAS protocols is thought to be an attenuation of the peri-operative stress response and early gut function. The core elements of ERAS protocols are preoperative advice, optimization of diet, systematic analgesic and anesthetic regimes, and early mobilization. It facilitates early mobilization and nutrition by controlling pain and dyspepsia, therefore reducing the postoperative length of stay, and allowing patients to return to their usual lifestyle as promptly as possible.

Although ERAS programs have become more popular over the past decade and the Association of Surgeons of Great Britain and Ireland, and ERAS society guidelines have recommended 23 guidelines for different surgical fields, it remains controversial and conflicts with the traditional doctrine for surgery. It therefore has been slow to be implemented so far. Also, no ERAS program for LCBDE was offered till now. Therefore, this study aimed to compare the efficacy and safety of ERAS versus conventional care in LCBDE.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with CBDS
  • American Society of Anesthesiologists (ASA) scores of I - II
  • Age 20-70 years

Exclusion criteria

  • Severe cholangitis
  • Severe pancreatitis
  • Mirizzi syndrome
  • Perforated gallbladder
  • Biliary peritonitis
  • Intrahepatic stones
  • Hepatobiliary malignancy
  • Pregnancy
  • Conversion to open surgery
  • Previous upper abdominal surgery

Treatment and study plan

ERAS

Procedure

Enhanced recovery after surgery (ERAS) programs are a combination of evidenced-based perioperative care approaches that work synergistically to improve recovery after surgery. The core elements of ERAS protocols are preoperative advice, optimization of diet, systematic analgesic and anesthetic regimes, and early mobilization.

Other names: Enhanced recovery after surgery

Conventional

Procedure

Conventional care for patients subjected for laparoscopic common bile duct exploration

Primary outcomes

  1. Lenghth of hospital stay

    Time frame: 1 - 30 days

    The duration from the surgery to discharge

Secondary outcomes

  1. Postoperative complications

    Time frame: 1 - 30 days

    the number of complications within 30 days postoperatively

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Enhanced Recovery After Surgery Program Versus Conventional Care for Laparoscopic Common Bile Duct Exploration: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.