Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery

Cholelithiasis Clinical Trial

Official title:

Prospective Randomized Clinical Trial Comparing Laparoscopic Cholecystectomy and Hybrid Natural Orifice Translumenal Endoscopic Surgery (NOTES)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835250
• Other study ID #: LLATZERNOTES-2
• Status: Completed
• Phase: Phase 3
• First received: February 2, 2009
• Last updated: March 11, 2013
• Start date: February 2009
• Est. completion date: April 2012

Study information

• Verified date: March 2013
• Source: Hospital Son Llatzer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• Transvaginal hybrid NOTES cholecystectomy
Cholecystectomy performed by using a combination of working tools inserted through the entry port for the minilaparoscopy and the videogastroscope, inserted into peritoneal cavity by transvaginal approach. The gallbladder is removed transvaginally through the videogastroscope.
• Cholecystectomy
Extirpation of the gallbladder by a surgical procedure

Locations

Country	Name	City	State
Spain	Hospital Son Llàtzer	Palma de Mallorca	Illes Balears.

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Son Llatzer

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Dolz C, Noguera JF, Martín A, Vilella A, Cuadrado A. [Transvaginal cholecystectomy (NOTES) combined with minilaparoscopy]. Rev Esp Enferm Dig. 2007 Dec;99(12):698-702. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parietal complications after surgery (infection and hernia)		One year	Yes
Secondary	Surgical pain. General complications. Patient's preferences.		One year	Yes