Chronic Abdominal Pain After Laparoscopic Sleeve Gastrectomy (Chron Pain LSG)

January 30, 2025 updated by: Piotr Mieszczanski, Medical University of Warsaw

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02-091
        • Medical University in Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post surgical group
Other: Questionnaire
Patients will receive a link to a web-based questionnaire on the prevalence and characteristics of pain symptoms including the PainDETECT questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PainDETECT Questionnaire score
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Actual)

November 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKBE/266/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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