Quality of Life Measures After Single Access Vs Conventional Laparoscopic Cholecystectomy: Prospective Randomized Study.

NCT ID: NCT01412996

Last Updated: 2012-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aimed to compare the short term outcomes between SALC and conventional laparoscopic cholecystectomy (CLC).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In a prospective study, two hundred fifty patients with symptomatic gall bladder stone were randomized to SALC or conventional laparoscopic cholecystectomy (CLC) (125 in each group). The primary endpoint of this study was to assess the total outcomes of quality of life using EuroQoL EQ-5D questionnaire. The secondary endpoints were postoperative pain, analgesia requirement and duration, operative time, perioperative complications, estimated blood loss, hospital stay, cosmoses outcomes and number of days required to return to normal activities.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Evidence of Cholecystectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

single ACCESS cholecystectomy

single ACCESS laparoscopic cholecystectomy

Group Type ACTIVE_COMPARATOR

surgery

Intervention Type PROCEDURE

single ACCESS laparoscopic cholecystectomy

traditional

conventional laparoscopic cholecystectomy

Group Type ACTIVE_COMPARATOR

SURGERY

Intervention Type OTHER

CONVENTIONAL LAPAROSCOPIC CGOLECYSTECTOMY

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

surgery

single ACCESS laparoscopic cholecystectomy

Intervention Type PROCEDURE

SURGERY

CONVENTIONAL LAPAROSCOPIC CGOLECYSTECTOMY

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SALC GROUP I CLC GROUP II

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* GALL BLADDER STONES

Exclusion Criteria

* ACUTE CHOLECYSTITIS
* PREVIOUS LAPAROTOMY
* ASA ABOVE 3
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

MOHAMED ABDELLATIF

ASS. PROF.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

RAMADAN ELLITHY, MD

Role: STUDY_CHAIR

Mansoura University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mohamed Abdellatif

Al Mansurah, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Single access chOLECYSTECTOMY

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Laparoscopic Cholecystectomy:
NCT04107909 UNKNOWN NA
Preoperative Counseling in Cholecystectomy
NCT01629992 COMPLETED PHASE2/PHASE3