Improving recovery in repeat laparoscopic surgery for bile duct stones using a modern care protocol
| ISRCTN | ISRCTN14816651 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14816651 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Second Affiliated Hospital of Soochow University |
| Funder | Second Affiliated Hospital of Soochow University |
- Submission date
- 22/03/2025
- Registration date
- 07/04/2025
- Last edited
- 31/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Surgery for bile duct stones can be challenging, especially in patients who have had previous operations. This study looks at whether a modern recovery protocol called "enhanced recovery after surgery" (ERAS) can help patients recover faster and more comfortably after repeat laparoscopic bile duct surgery.
Who can participate?
Adults aged 18 and over with confirmed extrahepatic bile duct stones and a history of biliary surgery, where endoscopic treatment was not successful.
What does the study involve?
Participants are randomly assigned to one of two groups. One group receives standard surgical care, while the other receives enhanced recovery care, including shorter fasting, early movement and feeding, and better pain control. Both groups undergo the same laparoscopic surgery.
What are the possible benefits and risks of participating?
Participants in the ERAS group may experience faster recovery and less discomfort. All procedures follow standard medical practices, and no unusual risks are expected.
Where is the study run from?
The Second Affiliated Hospital of Soochow University, China.
When is the study starting and how long is it expected to run for?
June 2017 to December 2025
Who is funding the study?
The Scientific Pre-research Foundation of the Second Affiliated Hospital of Soochow University, China
Who is the main contact?
Dr Lin Changjie, 631118863@qq.com
Contact information
Public, Scientific, Principal investigator
Department of Hepatobiliary Surgery
Nuclear Industry General Hospital (The Second Affiliated Hospital of Soochow University)
Suzhou
215004
China
| Phone | 67784099 |
|---|---|
| 631118863@qq.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center double-blind randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Application of enhanced recovery after surgery in the secondary surgery of extrahepatic bile duct stones |
| Study objectives | Primary Aim: To assess whether enhanced recovery after surgery (ERAS) protocols improve postoperative recovery, reduce inflammation and complications, and shorten hospital stay in patients undergoing laparoscopic biliary reoperation for extrahepatic bile duct stones. |
| Ethics approval(s) |
Approved 09/07/2024, Ethics Committee of the Second Affiliated Hospital of Soochow University (1055 Sanxiang Road, Suzhou, 215004, China; +86 512-6828-9999; sdfeylunli@163.com), ref: JD-LK2024-47-101 |
| Health condition(s) or problem(s) studied | Enhancing recovery surgery (ERAS) protocols after laparoscopic biliary reoperation for extrahepatic bile duct stones |
| Intervention | The patients were randomly divided into the ERAS group and the control group by block randomization with 30 cases in each group. The random numbers were generated by computer and allocated in a 1:1 ratio. The designer prepared random number envelopes and distributed them to the clinical doctors. The entire experimental process was without contact with the patients. Similarly, the clinical doctors responsible for patient enrollment, intervention implementation, and result analysis did not participate in the randomization process. ERAS Group: Patients received perioperative care following ERAS principles, including shortened fasting, carbohydrate loading, no routine nasogastric tube or bowel prep, early oral feeding and ambulation, controlled fluids, multimodal analgesia, and early removal of drains. Control Group: Patients received standard perioperative management, including prolonged fasting, traditional bowel prep, nasogastric decompression, delayed oral intake and ambulation, routine drain management, and conventional analgesia. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Pain intensity measured using the Faces Pain Scale – Revised at 6, 12, 18, 24, 48, and 72 hours postoperatively. |
| Key secondary outcome measure(s) |
1. Time to first anal ventilation (hours) recorded postoperatively |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. MRCP confirmed presence of extrahepatic bile duct stones with multiple stones and large diameters 2. There was a history of biliary tract surgery in the past, including cholecystectomy or biliary tract exploration 3. After confirmation by the gastroenterology doctor, ERCP could not remove the stones at one time 4. The extrahepatic bile duct is dilated with a diameter larger than 8 mm |
| Key exclusion criteria | 1. The diameter of extrahepatic bile duct is less than 8 mm 2. The number of extrahepatic bile duct stones is small, and their diameters are also small, and ERCP is expected to be able to remove all of them at one time 3. Severe cardiopulmonary dysfunction 4. History of choledochojejunostomy surgery |
| Date of first enrolment | 01/06/2017 |
| Date of final enrolment | 31/12/2019 |
Locations
Countries of recruitment
- China
Study participating centre
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
31/03/2025: Study's existence confirmed by the Ethics Committee of the Second Affiliated Hospital of Soochow University.
