Pain, PostoperativeNCT02738710
Comparison of Post-operative Pain at Umbilical Wound After Laparoscopic Cholecystectomy With Transumbilical Versus Infraumbilical Incision
A study testing transumbilical incision and Infra umbilical incision in people with Pain, Postoperative and Gallstone, run by Thammasat University at 1 site in Thailand.
Trial summary
This study compare outcomes (i.e. pain, wound infection, and patient satisfaction) between infra-umbilical vs. trans-umbilical incision after Laparoscopic cholecystectomy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Gallstone
- What is being tested?
- transumbilical incision and Infra umbilical incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2016to Nov 2017
- 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
- elective laparoscopic cholecystectomy
- willing to participate
Who cannot join
- pregnancy
- immunocompromised host
- on continuous ambulatory peritoneal dialysis
- morbid obesity (Body mass index > 35 kg/m2)
- End-stage renal disease with hemodialysis dependent
- ascites
- uncontrolled coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
This study compare outcomes (i.e. pain, wound infection, and patient satisfaction) between infra-umbilical vs. trans-umbilical incision after Laparoscopic cholecystectomy
Read the detailed description
Infra-umbilical wound have been used for a while with aim at improving cosmoses of the incision. Formerly, standard incision for laparoscopic cholecystectomy was infra-umbilical wound. However, no study directly compare these types of incisions in term of postoperative pain, wound infection, and patient satisfaction.
- Conditions
- Pain, Postoperative, Gallstone
- Being tested
- transumbilical incision, Infra umbilical incision
- Medical subject headings
- Pain, Postoperative, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transumbilical incisionProcedure or surgery
incision within umbilicus
Infra umbilical incisionProcedure or surgery
incision about 1 cm below umbilicus
| Study group | Role | What they receive |
|---|---|---|
| transumbilical wound | Experimental | transumbilical incision Receives: Procedure: transumbilical incision |
| infra umbilical wound | Active comparator | infra umbilical incision Receives: Procedure: Infra umbilical incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
visual analog scale (0-10)
Measured: 7 days postoperatively
Secondary outcomes (2)
wound infection
yes or no according to Center for Disease Control and Prevention (CDC) criteria
Measured: at 1 week and 1 month postoperatively
patient satisfaction
Visual analog scale (0-10)
Measured: 1 week and 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boonying Siribumrungwong, Thammasat University
- Investigators
- Trilak Chunsurisap, Study chair, Thammasat University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738710
- Sponsor's protocol ID
- MTU-EC-SU-1-042/59
- Status last verified
- Mar 2018
- First submitted
- 5 Apr 2016
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Siribumrungwong B, Chunsirisub T, Limpavitayaporn P, Tongyoo A, Sriussadaporn E, Mingmalairak C, Thowprasert W, Thakkinstian A. Comparison of postoperative pain at umbilical wound after conventional laparoscopic cholecystectomy between transumbilical and infraumbilical incisions: a randomized control trial. Surg Endosc. 2019 May;33(5):1578-1584. doi: 10.1007/s00464-018-6447-y. Epub 2018 Oct 22.
PubMed 30350096
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-operative Pain at Umbilical Wound After Laparoscopic Cholecystectomy With Transumbilical Versus Infraumbilical Incision
- ClinicalTrials.gov ID
- NCT02738710
- Acronym / sponsor ID
- MTU-EC-SU-1-042/59
- Conditions
- Pain, Postoperative, Gallstone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 14 Apr 2016 (estimated)
- 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.
This study compare outcomes (i.e. pain, wound infection, and patient satisfaction) between infra-umbilical vs. trans-umbilical incision after Laparoscopic cholecystectomy
Detailed description
Infra-umbilical wound have been used for a while with aim at improving cosmoses of the incision. Formerly, standard incision for laparoscopic cholecystectomy was infra-umbilical wound. However, no study directly compare these types of incisions in term of postoperative pain, wound infection, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transumbilical wound | Experimental | Procedure: transumbilical incisiontransumbilical incision |
| infra umbilical wound | Active comparator | Procedure: Infra umbilical incisioninfra umbilical incision |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective laparoscopic cholecystectomy
- willing to participate
Key exclusion criteria (7 listed)
- pregnancy
- immunocompromised host
- on continuous ambulatory peritoneal dialysis
- morbid obesity (Body mass index > 35 kg/m2)
- End-stage renal disease with hemodialysis dependent
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 |
|---|---|---|
| transumbilical incisionincision within umbilicus | Procedure or surgery | transumbilical wound |
| Infra umbilical incisionincision about 1 cm below umbilicus | Procedure or surgery | infra umbilical wound |
Primary outcome
Postoperative pain
Time frame: 7 days postoperatively
visual analog scale (0-10)
2 secondary outcomes
wound infection
Time frame: at 1 week and 1 month postoperatively
patient satisfaction
Time frame: 1 week and 3 months postoperatively
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 29 Mar 2018.
- Derived from this study: PubMed 30350096Siribumrungwong B, Chunsirisub T, Limpavitayaporn P, Tongyoo A, Sriussadaporn E, Mingmalairak C, Thowprasert W, Thakkinstian A. Comparison of postoperative pain at umbilical wound after conventional laparoscopic cholecystectomy between transumbilical and infraumbilical incisions: a randomized control trial. Surg Endosc. 2019 May;33(5):1578-1584. doi: 10.1007/s00464-018-6447-y. Epub 2018 Oct 22.
- 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.
Trilak Chunsurisap study chair
Thammasat University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transumbilical incision and Infra umbilical incision in people with Pain, Postoperative and Gallstone, run by Thammasat University at 1 site in Thailand.
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 2 inclusion and 7 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 29 Mar 2018. 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 Thailand. 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?
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 (time frame: 7 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02738710, which also lists 1 linked publication.
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 29 Mar 2018.