NCT06686875

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

November 11, 2024

Last Update Submit

January 30, 2025

Conditions

Keywords

laparoscopic sleeve gastrectomychronic postoperative painneuropathic pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (1)

  • PainDETECT Questionnaire score

    Baseline

Study Arms (1)

Post surgical group

Other: Questionnaire

Interventions

Patients will receive a link to a web-based questionnaire on the prevalence and characteristics of pain symptoms including the PainDETECT questionnaire.

Post surgical group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Patients who underwent laparoscopic sleeve gastrectomy 3 months to 5 years earlier

You may not qualify if:

  • Lack of patient consent to participate in the survey
  • No possibility to contact the patient
  • Revisional procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University in Warsaw

Warsaw, 02-091, Poland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

ObesityChronic PainAbdominal PainPain, PostoperativeNeuralgia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms, DigestivePostoperative ComplicationsPathologic ProcessesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2024

First Posted

November 13, 2024

Study Start

December 1, 2024

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

January 31, 2025

Record last verified: 2025-01

Locations