ObesityChron Pain LSGNCT06686875
Chronic Abdominal Pain After Laparoscopic Sleeve Gastrectomy
An observational study of Obesity and Chronic Pain, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The study aims to evaluate the prevalence of postoperative chronic pain, defined as the persistence of abdominal pain for more than 3 months after laparoscopic sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Chronic Pain, Abdominal Pain
- What is being tested?
- Questionnaire
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent surgery at the Department of General Surgery and Transplantology of the Medical University of Warsaw between January 2020 and December 2024
Who may be able to join
- Patients who underwent laparoscopic sleeve gastrectomy 3 months to 5 years earlier
Who cannot join
- Lack of patient consent to participate in the survey
- No possibility to contact the patient
- Revisional procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of the Prevalence of Persistent Postoperative Pain in Patients Undergoing Laparoscopic Gastrectomy
The study aims to evaluate the prevalence of postoperative chronic pain, defined as the persistence of abdominal pain for more than 3 months after laparoscopic sleeve gastrectomy.
Read the detailed description
The main goal of this study is to determine the incidence of chronic abdominal pain among patients who have undergone laparoscopic sleeve gastrectomy. Patients who underwent this type of surgery at the Department of General Surgery and Transplantology of the Medical University of Warsaw between January 2020 and August 2024 will be qualified for the study. The participants will be asked to complete an online questionnaire, including a pain scale and PainDETECT Questionnaire.
- Conditions
- Obesity, Chronic Pain, Abdominal Pain
- Being tested
- Questionnaire
- Keywords
- laparoscopic sleeve gastrectomy, chronic postoperative pain, neuropathic pain
- Medical subject headings
- Obesity, Chronic Pain, Abdominal Pain, Pain, Postoperative, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Patients will receive a link to a web-based questionnaire on the prevalence and characteristics of pain symptoms including the PainDETECT questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Post surgical group | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of chronic abdominal pain after laparoscopic sleeve gastrectomy
The presence of pain after laparoscopic sleeve gastrectomy, which persists more than 3 months postoperatively.
Measured: Baseline
Secondary outcomes (1)
PainDETECT Questionnaire score
PainDETECT is a simple, easy-to-use screening questionnaire. The questionnaire consists of 9 items and is completed by the patient. There are 7 weighted sensory descriptor items (never to very strongly) and 2 items relating to spatial and temporal pain characteristics. A total score of 19 or more is indicative of likely neuropathic pain.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 Dec 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
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 ObesityStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Mieszczanski, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686875
- Sponsor's protocol ID
- AKBE/266/2024
- Acronym
- Chron Pain LSG
- Status last verified
- Jan 2025
- First submitted
- 11 Nov 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mieszczanski P, Jurczak M, Kolacz M, Gorniewski G, Godlewska I, Ziemianski P, Cylke R, Lisik W, Trzebicki J. Chronic Post-Surgical Pain After Laparoscopic Sleeve Gastrectomy: Is the Opioid-Free Anesthesia Superior? A Cross-Sectional Study. J Clin Med. 2025 Oct 30;14(21):7721. doi: 10.3390/jcm14217721.
PubMed 41227115
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Prevalence of Persistent Postoperative Pain in Patients Undergoing Laparoscopic Gastrectomy
- ClinicalTrials.gov ID
- NCT06686875
- Acronym / sponsor ID
- Chron Pain LSG / AKBE/266/2024
- Conditions
- Obesity, Chronic Pain, Abdominal Pain
- Keywords
- laparoscopic sleeve gastrectomy, chronic postoperative pain, neuropathic pain
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 13 Nov 2024 (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.
The study aims to evaluate the prevalence of postoperative chronic pain, defined as the persistence of abdominal pain for more than 3 months after laparoscopic sleeve gastrectomy.
Detailed description
The main goal of this study is to determine the incidence of chronic abdominal pain among patients who have undergone laparoscopic sleeve gastrectomy. Patients who underwent this type of surgery at the Department of General Surgery and Transplantology of the Medical University of Warsaw between January 2020 and August 2024 will be qualified for the study. The participants will be asked to complete an online questionnaire, including a pain scale and PainDETECT Questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post surgical group | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent surgery at the Department of General Surgery and Transplantology of the Medical University of Warsaw between January 2020 and December 2024
Key inclusion criteria (1 listed)
- Patients who underwent laparoscopic sleeve gastrectomy 3 months to 5 years earlier
Key exclusion criteria (3 listed)
- Lack of patient consent to participate in the survey
- No possibility to contact the patient
- Revisional procedures
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 |
|---|---|---|
| QuestionnairePatients will receive a link to a web-based questionnaire on the prevalence and characteristics of pain symptoms including the PainDETECT questionnaire. | Other | Post surgical group |
Primary outcome
The presence of chronic abdominal pain after laparoscopic sleeve gastrectomy
Time frame: Baseline
The presence of pain after laparoscopic sleeve gastrectomy, which persists more than 3 months postoperatively.
1 secondary outcome
PainDETECT Questionnaire score
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 41227115Mieszczanski P, Jurczak M, Kolacz M, Gorniewski G, Godlewska I, Ziemianski P, Cylke R, Lisik W, Trzebicki J. Chronic Post-Surgical Pain After Laparoscopic Sleeve Gastrectomy: Is the Opioid-Free Anesthesia Superior? A Cross-Sectional Study. J Clin Med. 2025 Oct 30;14(21):7721. doi: 10.3390/jcm14217721.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Chronic Pain, run by Medical University of Warsaw at 1 site in Poland.
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 1 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 31 Jan 2025. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
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?
The presence of chronic abdominal pain after laparoscopic sleeve gastrectomy (time frame: Baseline). 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 NCT06686875, 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 31 Jan 2025.