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

Mansoura University

Status: Completed

Conditions: Evidence of Cholecystectomy

Treatments: Other: SURGERY; Procedure: surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01412996

Single access chOLECYSTECTOMY

Details and patient eligibility

About

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

Full description

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.

Enrollment: 250 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• GALL BLADDER STONES

Exclusion criteria

• ACUTE CHOLECYSTITIS
• PREVIOUS LAPAROTOMY
• ASA ABOVE 3

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

250 participants in 2 patient groups

single ACCESS cholecystectomy

Active Comparator group

Description:

single ACCESS laparoscopic cholecystectomy

Treatment:

Procedure: surgery

traditional

Active Comparator group

Description:

conventional laparoscopic cholecystectomy

Treatment:

Other: SURGERY