Comparing two types of keyhole surgery for gallbladder removal: A clinical trial
| ISRCTN | ISRCTN50339464 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50339464 |
- Submission date
- 09/09/2024
- Registration date
- 11/09/2024
- Last edited
- 18/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
This study aims to compare two different methods of performing keyhole surgery for removing the gallbladder in patients with gallstones. The first method, known as conventional laparoscopic cholecystectomy (CLC), uses three small instruments to ensure a safe view of the surgical area. The second method, called two ports plus one puncture laparoscopic cholecystectomy (TPPOP LC), uses a slightly different technique that involves fewer entry points but still provides a clear view for the surgeon. The study will compare the outcomes of these two methods to determine if the new approach is as safe and effective as the standard one.
Who can participate?
Patients aged 12 - 80 years who have gallstones causing symptoms and require gallbladder removal surgery can participate in this study. Participants should be classified as ASA I or II, which means they are either healthy or have only mild, controlled health conditions.
What does the study involve?
Participants will undergo one of two types of keyhole surgery to remove the gallbladder. They will be randomly assigned to either the conventional laparoscopic cholecystectomy (CLC) or the two ports plus one puncture laparoscopic cholecystectomy (TPPOP LC). All participants will receive the standard care and monitoring before, during, and after surgery.
What are the possible benefits and risks of participating?
The conventional laparoscopic surgery is the current standard method and has a low risk of complications, such as wound infections, pain, bleeding, or injury to nearby structures like the bile duct, bowel, or liver. There is a small chance (1% to 2%) of injury to the bile duct, and in rare cases, the surgery may need to be converted to an open procedure (less than 1%).
The newer two ports plus one puncture approach may involve a slightly longer operation time but could reduce the number of incisions. However, it also carries similar risks of complications, including wound infections, pain, bleeding, and injury to nearby structures, with a bile duct injury rate of 1% to 3%. If complications occur, the surgery may need to be switched to the conventional method (around 5.45% of cases) or to an open surgery (about 0.18% of cases).
Where is the study run from?
The study is being conducted at the No. (1) Military Hospital (700 bedded) in Pyin Oo Lwin, Myanmar.
When is the study starting and how long is it expected to run for?
April 2019 to September 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Min Nay Zar Wyke, minnayzarwyke3681@gmail.com
Contact information
Public, Scientific, Principal Investigator
Yay Chan Oe Quater, Block 12
Pyin Oo Lwin
05081
Myanmar
 ORCID ID |
0009-0005-0986-1047 |
|---|---|
| Phone | +95 95501867 |
| minnayzarwyke3681@gmail.com |
Study information
| Study design | Single-center hospital based interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 46054 PIS.pdf |
| Scientific title | Conventional versus two ports plus one puncture laparoscopic cholecystectomy: A clinical trial |
| Study objectives | Two ports plus one puncture laparoscopic cholecystectomy is as safe and effective as conventional laparoscopic cholecystectomy. |
| Ethics approval(s) |
Approved 14/11/2019, Ethical Review Committee, Defence Services Medical Academy (No. 94, D-1, Pyay Road, Mingalardon, Yangon, 11021, Myanmar; +95 03135062; registrardsma@gmail.com), ref: 11/Ethics 2018 |
| Health condition(s) or problem(s) studied | Two ports plus one puncture laparoscopic cholecystectomy is as safe and effective as conventional laparoscopic cholecystectomy. |
| Intervention | This is a hospital-based, interventional, randomized controlled study that was carried out over a period of 21 months in a surgical unit at No. (1) Military Hospital (700 bedded) in Pyin Oo Lwin, Myanmar. All patients with symptomatic gallstones who were treated by laparoscopic cholecystectomy were included in the study. Patients with ASA III, IV & V, previous upper abdominal surgery, common bile duct pathology, clinical or USG suspected gall bladder cancer, and bleeding disorders were excluded from the study. Patients were evaluated using a detailed history, a thorough physical examination, and investigations such as liver function tests, a complete blood picture, urea, creatinine, viral serology, and abdominal sonography. An informed written consent explaining the research procedure was obtained at least one day before surgery. The patients were randomized into group A (CLC) (n = 49) and group B (TPPOP LC) (n = 49). In conventional laparoscopic cholecystectomy, the procedure will be done with four ports which will be placed 10 mm port in the subumbilical region, another 10 mm port in the subxiphoid epigastric region, 5 mm port in the right subcostal midclavicular line and another 5 mm port in the right subcostal anterior axillary line location. In two ports plus one puncture laparoscopic cholecystectomy, the procedure will be done with two ports, which will be placed 10 mm port in the subumbilical region, 5 mm port in the subxiphoid epigastric region, and with 2.3 mm alligator grasper which will be punctured below the right costal margin. The end points of this research were to compare operation time, intraoperative complications, conversion rate, postoperative pain, postoperative complications, and postoperative hospital stay. Statistics were analyzed on a total of 98 patients by using SPSS software package version 28.0. The categorical data was calculated by the statistical method Chi-square. For continuous variables, the statistical significance of patients was analyzed by two independent Student’s t tests. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Measured using patient records unless noted otherwise: 1. The operation time is noted from the time of skin incision to the last stitch of skin closure. 2. Intraoperative complications including bile duct injury, bowel injury, vascular injury, and injuries to nearby structures are observed in all cases during operation. 3. Postoperative pain is measured using a visual analogue scale (VAS) within 12 hour, 24 hour, 36 hour and 48 hour. 4. Rescue analgesia is added with injection of intravenous tramadol 1mg/kg if VAS is more than 4 and/or if the patient suffers breakthrough pain or if the patient complains of pain between the assessments. 5. Postoperative complications like prolonged ileus and wound infection in all cases are observed daily during the hospital stay. 6. The duration of a hospital stay is measured from the time it takes from the date of surgery to the date of discharge based on the discharge criteria. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/04/2019 |
| Completion date | 30/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 12 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 98 |
| Total final enrolment | 98 |
| Key inclusion criteria | All patients with symptomatic gall stones with ASA I & II |
| Key exclusion criteria | 1. Patients with ASA III, IV & V 2. Previous upper abdominal surgery 3. Patients with common bile duct pathology 4. Patients with clinical or USG suspected gall bladder cancer 5. Patients with bleeding disorders |
| Date of first enrolment | 01/12/2019 |
| Date of final enrolment | 31/07/2021 |
Locations
Countries of recruitment
- Myanmar
Study participating centre
Pyin Oo Lwin
05081
Myanmar
Sponsor information
Government
No. 94, D-1, Pyay Road, Mingalardon
Yangon
11021
Myanmar
| info@dsma.edu.mm |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 10/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request Min Nay Zar Wyke Email: minnayzarwyke3681@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 11/09/2024 | No | Yes | ||
| Protocol file | 11/09/2024 | No | No |
Additional files
Editorial Notes
18/10/2024: The intention to publish date was changed from 10/10/2024 to 10/03/2025.
11/09/2024: Trial's existence confirmed by Ethical Review Committee, Defence Services Medical Academy.
