Laparoscopic CholecystectomyNCT03067038
Single Incision Versus Three Port Laparoscopic Cholecystectomy
A study testing Single incision laparoscopic cholecystectomy and Three port laparoscopic cholecystectomy in people with Laparoscopic Cholecystectomy, run by South Valley University.
Trial summary
Laparoscopic cholecystectomy (LC) became the standard treatment for symptomatic gallbladder disease. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Single incision laparoscopic cholecystectomy and Three port laparoscopic cholecystectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Oct 2016
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- preoperative diagnosis of symptomatic gallstones
- age from 20 to 60 years,
- American Society of Anesthesiologists (ASA) grade I, II or III,
- agreement to complete the study requirement.
Who cannot join
- patients with contraindication to laparoscopy,
- suspected Mirizzi syndrome,
- choledocholithiasis,
- hepatobiliary malignancy,
- previous upper abdominal surgery,
- previous mesh repair of an umbilical hernia,
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- long-term anticoagulant treatment,
- pregnant female
- stone more than 2 cm in preoperative ultrasonography.
About this study
Official title: Single Incision Versus Three Port Laparoscopic Cholecystectomy in Symptomatic Gallstones: A Prospective Randomized Study
Laparoscopic cholecystectomy (LC) became the standard treatment for symptomatic gallbladder disease. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. The aim of this study was to compare the clinical outcome of single-incision laparoscopic cholecystectomy (SILC) with three port laparoscopic cholecystectomy (TPLC).
Read the detailed description
From February 2014 to September 2016, patients with symptomatic cholecystolithiasis at two university hospitals (Sohag University and Qena University hospitals) were enrolled in this study.
The number of patients needed was calculated. Considering a power of 80% and reliability of 0.05, the investigator found that 76 patients should be present in each group. The study was started with 275 patients for the possible loss of patients and data during the study. Eligible patients (206 patients) were randomly divided equally into two groups (Group 1; SILC, Group 2; TPLC) according to a computer-generated random numbers. Of 103 patients allocated to intervention in each group, 14 patients were excluded from SILC group and 5 patients from TPLC group, and the remaining 89 \& 98 patients in SILC \& TPLC group respectively were included in the study.
Routine investigations and surgical fitness were done in all cases. Patient demographics, BMI, ASA score, indication for cholecystectomy, operative time, estimated blood loss, success and conversion rate, postoperative pain score, postoperative analgesia requirement, morbidity and mortality, length of hospital stay, and patient cosmetic satisfaction were recorded.
A fixed analgesia protocol with intravenous non-narcotic (ketorolac tromethamine 30 mg) was used twice daily. An opioid (pethidine Hcl 50 mg) was added when the pain cannot be tolerable. Postoperative pain was evaluated according to a visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain) on the postoperative sixth hour (VAS-6H) and on postoperative day one (VAS-24H). Patient cosmetic satisfaction was recorded at one month follow-up visit on a scale from 1 (worst) to 10 (best). Patients were shown the same photograph of a right sub-costal (Kocher) incision which was rated 0 on the cosmetic scale and were asked to rate their satisfaction based on the previous observation. The study protocol was approved by the local ethical committee. Also, a written informed consent was obtained from all patients' prior recruitment to study.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Single incision laparoscopic cholecystectomy, Three port laparoscopic cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single incision laparoscopic cholecystectomyDevice
Laparoscopic cholecystectomy with single port device
Three port laparoscopic cholecystectomyDevice
Laparoscopic cholecystectomy with three port
| Study group | Role | What they receive |
|---|---|---|
| Single incision LC | Active comparator | Single incision laparoscopic cholecystectomy (SILC) performed through a single infra-umbilical incision using a single port device or three ports closely placed. Receives: Device: Single incision laparoscopic cholecystectomy |
| Three port LC | Sham comparator | Three port laparoscopic cholecystectomy (TPLC) performed through three different placed trocars Receives: Device: Three port laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain, visual analogue scale (VAS)
Postoperative pain was evaluated according to a visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain) on the postoperative hour six (VAS-6H).
Measured: at 6 hours
postoperative pain, visual analogue scale (VAS)
Postoperative pain was evaluated according to a visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain) on the postoperative day one (VAS-24H).
Measured: at 24 hours
Secondary outcomes (4)
operative duration
Measured: From introduction of first trocar to the recovery of patient, up to 10 hours
post operative opioid requirements (questioner)
Measured: 24 hours
lenght of hospital stay
Measured: from recovery of anaesthesia to discharge of patient, up to 4 days
cosmetic satisfactions (aesthetic scale)
Patient aesthetic satisfaction was recorded at one month follow-up visit on a scale from 1 (worst) to 10 (best). Patients were shown the same photograph of a right sub-costal (Kocher) incision which was rated 0 on the aesthetic scale and were asked to rate their satisfaction based on the previous observation.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study startOct 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ahmed Omar, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067038
- Sponsor's protocol ID
- SVU
- Status last verified
- Feb 2017
- First submitted
- 25 Nov 2016
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Incision Versus Three Port Laparoscopic Cholecystectomy in Symptomatic Gallstones: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03067038
- Acronym / sponsor ID
- SVU
- Conditions
- Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Mar 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.
Laparoscopic cholecystectomy (LC) became the standard treatment for symptomatic gallbladder disease. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. The aim of this study was to compare the clinical outcome of single-incision laparoscopic cholecystectomy (SILC) with three port laparoscopic cholecystectomy (TPLC).
Detailed description
From February 2014 to September 2016, patients with symptomatic cholecystolithiasis at two university hospitals (Sohag University and Qena University hospitals) were enrolled in this study.
The number of patients needed was calculated. Considering a power of 80% and reliability of 0.05, the investigator found that 76 patients should be present in each group. The study was started with 275 patients for the possible loss of patients and data during the study. Eligible patients (206 patients) were randomly divided equally into two groups (Group 1; SILC, Group 2; TPLC) according to a computer-generated random numbers. Of 103 patients allocated to intervention in each group, 14 patients were excluded from SILC group and 5 patients from TPLC group, and the remaining 89 \& 98 patients in SILC \& TPLC group respectively were included in the study.
Routine investigations and surgical fitness were done in all cases. Patient demographics, BMI, ASA score, indication for cholecystectomy, operative time, estimated blood loss, success and conversion rate, postoperative pain score, postoperative analgesia requirement, morbidity and mortality, length of hospital stay, and patient cosmetic satisfaction were recorded.
A fixed analgesia protocol with intravenous non-narcotic (ketorolac tromethamine 30 mg) was used twice daily. An opioid (pethidine Hcl 50 mg) was added when the pain cannot be tolerable. Postoperative pain was evaluated according to a visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain) on the postoperative sixth hour (VAS-6H) and on postoperative day one (VAS-24H). Patient cosmetic satisfaction was recorded at one month follow-up visit on a scale from 1 (worst) to 10 (best). Patients were shown the same photograph of a right sub-costal (Kocher) incision which was rated 0 on the cosmetic scale and were asked to rate their satisfaction based on the previous observation. The study protocol was approved by the local ethical committee. Also, a written informed consent was obtained from all patients' prior recruitment to study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single incision LC | Active comparator | Device: Single incision laparoscopic cholecystectomySingle incision laparoscopic cholecystectomy (SILC) performed through a single infra-umbilical incision using a single port device or three ports closely placed. |
| Three port LC | Sham comparator | Device: Three port laparoscopic cholecystectomyThree port laparoscopic cholecystectomy (TPLC) performed through three different placed trocars |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- preoperative diagnosis of symptomatic gallstones
- age from 20 to 60 years,
- American Society of Anesthesiologists (ASA) grade I, II or III,
- agreement to complete the study requirement.
Key exclusion criteria (9 listed)
- patients with contraindication to laparoscopy,
- suspected Mirizzi syndrome,
- choledocholithiasis,
- hepatobiliary malignancy,
- previous upper abdominal surgery,
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 |
|---|---|---|
| Single incision laparoscopic cholecystectomyLaparoscopic cholecystectomy with single port device | Device | Single incision LC |
| Three port laparoscopic cholecystectomyLaparoscopic cholecystectomy with three port | Device | Three port LC |
Primary outcome
postoperative pain, visual analogue scale (VAS)
Time frame: at 6 hours
Postoperative pain was evaluated according to a visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain) on the postoperative hour six (VAS-6H).
postoperative pain, visual analogue scale (VAS)
Time frame: at 24 hours
Postoperative pain was evaluated according to a visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain) on the postoperative day one (VAS-24H).
4 secondary outcomes
operative duration
Time frame: From introduction of first trocar to the recovery of patient, up to 10 hours
post operative opioid requirements (questioner)
Time frame: 24 hours
lenght of hospital stay
Time frame: from recovery of anaesthesia to discharge of patient, up to 4 days
cosmetic satisfactions (aesthetic scale)
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Single incision laparoscopic cholecystectomy and Three port laparoscopic cholecystectomy in people with Laparoscopic Cholecystectomy, run by South Valley University.
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 4 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: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain, visual analogue scale (VAS) (time frame: at 6 hours). The study lists 2 primary outcomes in all. 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 1 Mar 2017; AzTrials last refreshed its copy on 1 Nov 2026.