Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery

Hospital Son Llatzer

Status and phase: Completed; Phase 3

Conditions: Cholelithiasis

Treatments: Procedure: Transvaginal hybrid NOTES cholecystectomy; Procedure: Cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00835250

LLATZERNOTES-2

Details and patient eligibility

About

The purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic surgery).

Full description

Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. At the present time these procedures are hybrids. It is expected a better cosmetic result and lower incidence in parietal complications in front of laparoscopic cholecystectomy, but is necessary to investigate that these benefits should not be associated with complications of the new access to abdominal cavity.

Methods. Prospective randomized clinical series of 60 female patients with gallstones that underwent endoscopic surgery, 20 of them operated with conventional laparoscopic approach, 20 by transumbilical endoscopic approach and 20 of them by transvaginal endoscopic approach. Variables as surgical wound infection, urinary tract infection, evisceration, hernia, mortality and other complications will be analyzed.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age over 18 and under 65
• symptomatic cholelithiasis with an indication for performing laparoscopic surgery
• absence of any gynecological condition that could complicate the procedure (pelvic inflammatory disease or endometriosis)
• perforated hymen
• agreement on the patient's part not to use the vagina for two weeks after the surgery
• signed specific informed consent upon providing specific information about the new surgical approach.

Exclusion criteria

• age under 18 or over 65
• unperforated hymen
• presence of illness or condition with an increased risk of pelvic damage with transvaginal approach.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Laparoscopy

Active Comparator group

Description:

Laparoscopic cholecystectomy

Treatment:

Procedure: Cholecystectomy

Transumbilical

Experimental group

Description:

Transumbilical endoscopic cholecystectomy

Treatment:

Procedure: Cholecystectomy

Transvaginal

Experimental group

Description:

Transvaginal endoscopic cholecystectomy

Treatment:

Procedure: Cholecystectomy

Procedure: Transvaginal hybrid NOTES cholecystectomy