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Laparo- Endoscopic Single site Surgery vs Conventional Laparoscopic Removal of the Gall Bladder

Laparo- Endoscopic Single site Surgery vs Conventional Laparoscopic Removal of the Gall Bladder - GALLESS study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34133
Enrollment
60
Registered
2010-09-27
Start date
2010-09-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gallbladder removal Symptomatic Gallstones

Interventions

The conventional technique Patients undergo surgery under general anesthesia and positioned in the supine position. The operator is left of the patient. The other set-up is as usual in a laparosco

Sponsors

Alysis Zorggroep
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient on waitinglist for laparoscopic gallbladder removal Age between 18 and 70 years BMI

Exclusion criteria

Exclusion criteria: In Prior history; Cholecystitis, ERCP, Upper GI surgery, other liver disease, Cancer in upper GI trackt, Alcohol or substance abuse Participation in other research Psychiatric condition Unability to comply to study criteria Patients without social network/ unable to care for themselves Pregnancy

Design outcomes

Primary

MeasureTime frame
Main objective research Investigate whether a significant difference in pain (VAS score) between the conventional laparoscopic approach and the approach for a gallbladder removal LESS Either VAS scores

Secondary

MeasureTime frame
Secondary goals a. Explore the possibility of a significant difference in abdominal and umbilical rupture between the different approaches b. Investigate whether a significant difference in wound infection between the different approaches. c. Investigate whether a difference in patient satisfaction as to the final outcome between the different approaches. d. Investigate whether there is a difference in overall complications between the different approaches e. Investigate whether there is a difference in operative time f. Investigate whether there is a difference in treatment costs Either outcome echoes observations infection outcome, VAS score

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)