Pain and Nausea After Gallbladder Surgery

NCT06083558 | Recruiting

• 1 other identifier: GALLSPOR
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief Summary

The study is primarily an exploratory study of quality registry data for a swedish national cohort of patients who have undergone gallbladder surgery or ERCP, with the aim of investigating the occurrence of pain and PONV (Postoperative Nausea and Vomiting) after gallbladder surgery. Furthermore, the investigators will explorer if there are factors related to the patient or the surgical procedure that are associated with a higher risk of PONV or pain.

Conditions

PONV; Postoperative Pain; Postoperative Complications; Gall Bladder Disease

Keywords

cholecystectomy

Outcome Measures

Primary Outcomes (4)

• Postoperative nausea and vomiting

  Incidence of PONV in the postoperative ward (number of surgical cases with nausea and/or vomiting) / \[total number of surgical cases\].

  Through the stay at the PACU, an average of 3.5 hours

• Postoperative Pain

  Median pain score (NRS) in the postoperative ward. NRS = Numerical Rating Scale 0-10. 0 = No pain and 10 = Worst imaginable pain

  Through the stay at the PACU, an average of 3.5 hours

• Severe postoperative pain

  Incidence of severe pain (NRS\>=7) \[number of surgical cases with NRS\>=7\] / \[total number of surgical cases\]. NRS = Numerical Rating Scale 0-10. 0 = No pain and 10 = Worst imaginable pain

  Through the stay at the PACU, an average of 3.5 hours

• Complications after surgery

  Percentage of patients with complications, unplanned hospitalizations, or reoperations after 30 days and 6 months

  up to 6 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients that had undergone gallbladder surgery in Sweden.

You may qualify if:

• Primary gallstone surgery
• Adult patients (\>=18 years)
• Procedure performed between 2016 and 2025
• Surgical procedure registered in the national quality registry Gallriks.

You may not qualify if:

• If multiple surgeries on the same patient in the study database, subsequent procedures to the first procedure is excluded.

Sponsors & Collaborators

• Umeå University: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Umeå University, Dept of surgical and perioperative sciences

Sundsvall, X, 85357, Sweden

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative; Postoperative Complications; Gallbladder Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Jakob Wallden, MD PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakob Wallden, MD PhD

CONTACT

+46703644392; jakob.wallden@umu.se

Tomi Myrberg, MD PhD

CONTACT

tomi.myrberg@umu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 16, 2023
• Study Start: January 1, 2016
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

SE (1)