Enhanced Recovery After SurgeryNCT03120754
Study of Abdominal Drainage in LCBDE+PC
A study testing Place the peritoneal drainage and No peritoneal drainage in people with Enhanced Recovery After Surgery, run by Zhongshan Hospital Xiamen University at 1 site in China.
Trial summary
Common bile duct stones in clinical manifestations of biliary colic, obstructive jaundice, cholangitis, pancreatitis and other symptoms. At present, thanks to the rapid development of minimally invasive surgery and the concept of ERAS, laparoscopic common bile duct incision and primary suture has been gradually used… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Enhanced Recovery After Surgery
- What is being tested?
- Place the peritoneal drainage and No peritoneal drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cholecystocholedocholithiasis or simple choledocholithiasis, no intrahepatic bile duct stones, bile duct diameter greater than 8 mm;
- no acute suppurative cholangitis or severe acute biliary pancreatitis;
- all patients were treated with internal medicine before operation, such as anti inflammation, liver protection, correction of anemia, hypoproteinemia, disturbance of electrolyte and acid-base imbalance;
- there was no obvious stenosis of common bile duct;
- aged from 18 to 80 years;
- BMI<30 kg / m2;
- American Society of anesthesiologists (ASA) anesthesia risk rating of 1 or 2.
Who cannot join
- severe anemia or thrombocytopenia in patients with 50*109/L, PT is greater than 15s and can not correct the coagulation disorders;
- severe heart and lung complications can not tolerate pneumoperitoneum and other laparoscopic surgery contraindications;
- IgG4 associated cholangitis and other immune system diseases;
- there is a serious systemic disease. The patients with the following conditions:
- there was inflammatory stenosis or Oddi sphincter hyperemia and edema at the lower end of the common bile duct;
- in acute inflammation in patients with obstructive jaundice, such patients have biliary dilatation, the bile duct wall edema obviously and easily with bile duct opening at the lower end of the inflammatory edema, biliary high pressure, suture of bile duct after prone to bile leakage;
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- the presence of severe cholangitis requiring emergency biliary drainage;
- it is difficult to get a combination of intrahepatic bile duct stones and choledochoscopy;
- Mirizzi syndrome type II-IV.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of hepatobiliary and pancreatic surgery; Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, 361000
About this study
Official title: Clinical Study of Abdominal Drainage in Laparoscopic Common Bile Duct Exploration With Primary Closure
Common bile duct stones in clinical manifestations of biliary colic, obstructive jaundice, cholangitis, pancreatitis and other symptoms. At present, thanks to the rapid development of minimally invasive surgery and the concept of ERAS, laparoscopic common bile duct incision and primary suture has been gradually used as a routine surgical approach in clinical application. However, whether or not to place the abdominal drainage tube after surgery, so far has not yet reached a consensus. Therefore, this study focuses on the clinical advantages of LCBDE+PC placed abdominal drainage.
Read the detailed description
On the basis of the analysis of 7 cases were selected by laparoscopic treatment of cholecystolithiasis complicated with choledocholithiasis bile duct suture in patients with a clinical data of our hospital were prospectively divided into peritoneal drainage group of 40 cases, no abdominal drainage group of 40 cases, compared two groups of operation time, hospitalization time and cost, operation cost, operation bleeding and postoperative bilirubin recovery, complication and return to hospital again and so on, and to explore the clinical significance of indwelling drainage tube.
- Conditions
- Enhanced Recovery After Surgery
- Being tested
- Place the peritoneal drainage, No peritoneal drainage
- Keywords
- ERAS, Peritoneal drainage, Primary Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Place the peritoneal drainageProcedure or surgery
In the experimental group, the abdominal drainage was not placed
No peritoneal drainageProcedure or surgery
Intraoperative placement of peritoneal drainage as control group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Placement of peritoneal drainage Receives: Procedure: Place the peritoneal drainage |
| Control group | Active comparator | No peritoneal drainage Receives: Procedure: No peritoneal drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital stay
length of patient stay.
Measured: 3 days
Secondary outcomes (1)
Postoperative pain
Observation on pain after operation in the two groups, were evaluated according to the standard for evaluation of VAS pain score.
Measured: 24 and 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start24 Mar 2017
- Primary completion30 Jul 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SPSS statistical analysis system by the deputy director of our department physician, accepted treatment of 80 subjects (test group and control group) randomly arranged, which lists the serial number from 1 to 80 corresponding to the treatment assignment. In the experiment, 1 patients were divided into the exper
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Hospital Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianyin Zhou, Zhongshan Hospital Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120754
- Sponsor's protocol ID
- 011314
- Status last verified
- Mar 2017
- First submitted
- 7 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Abdominal Drainage in Laparoscopic Common Bile Duct Exploration With Primary Closure
- ClinicalTrials.gov ID
- NCT03120754
- Acronym / sponsor ID
- 011314
- Conditions
- Enhanced Recovery After Surgery
- Keywords
- ERAS, Peritoneal drainage, Primary Closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhongshan Hospital Xiamen UniversityUniversity, hospital or other
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Common bile duct stones in clinical manifestations of biliary colic, obstructive jaundice, cholangitis, pancreatitis and other symptoms. At present, thanks to the rapid development of minimally invasive surgery and the concept of ERAS, laparoscopic common bile duct incision and primary suture has been gradually used as a routine surgical approach in clinical application. However, whether or not to place the abdominal drainage tube after surgery, so far has not yet reached a consensus. Therefore, this study focuses on the clinical advantages of LCBDE+PC placed abdominal drainage.
Detailed description
On the basis of the analysis of 7 cases were selected by laparoscopic treatment of cholecystolithiasis complicated with choledocholithiasis bile duct suture in patients with a clinical data of our hospital were prospectively divided into peritoneal drainage group of 40 cases, no abdominal drainage group of 40 cases, compared two groups of operation time, hospitalization time and cost, operation cost, operation bleeding and postoperative bilirubin recovery, complication and return to hospital again and so on, and to explore the clinical significance of indwelling drainage tube.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SPSS statistical analysis system by the deputy director of our department physician, accepted treatment of 80 subjects (test group and control group) randomly arranged, which lists the serial number from 1 to 80 corresponding to the treatment assignment. In the experiment, 1 patients were divided into the exper
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Place the peritoneal drainagePlacement of peritoneal drainage |
| Control group | Active comparator | Procedure: No peritoneal drainageNo peritoneal drainage |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- cholecystocholedocholithiasis or simple choledocholithiasis, no intrahepatic bile duct stones, bile duct diameter greater than 8 mm;
- no acute suppurative cholangitis or severe acute biliary pancreatitis;
- all patients were treated with internal medicine before operation, such as anti inflammation, liver protection, correction of anemia, hypoproteinemia, disturbance of electrolyte and acid-base imbalance;
- there was no obvious stenosis of common bile duct;
- aged from 18 to 80 years;
Key exclusion criteria (9 listed)
- severe anemia or thrombocytopenia in patients with 50*109/L, PT is greater than 15s and can not correct the coagulation disorders;
- severe heart and lung complications can not tolerate pneumoperitoneum and other laparoscopic surgery contraindications;
- IgG4 associated cholangitis and other immune system diseases;
- there is a serious systemic disease. The patients with the following conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Place the peritoneal drainageIn the experimental group, the abdominal drainage was not placed | Procedure or surgery | Experimental Group |
| No peritoneal drainageIntraoperative placement of peritoneal drainage as control group. | Procedure or surgery | Control group |
Primary outcome
Hospital stay
Time frame: 3 days
length of patient stay.
1 secondary outcome
Postoperative pain
Time frame: 24 and 48hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Place the peritoneal drainage and No peritoneal drainage in people with Enhanced Recovery After Surgery, run by Zhongshan Hospital Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhou Jianyin (+86 13606097132, zhoujianyin2000@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital stay (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.