Clinical trial NCT00835250: Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery
Official title: Prospective Randomized Clinical Trial Comparing Laparoscopic Cholecystectomy and Hybrid Natural Orifice Translumenal Endoscopic Surgery (NOTES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cholelithiasis
Keywords: Transvaginal cholecystectomy
NOTES
Minilaparoscopy
Endoscopic surgery
Cholecystectomy
Surgical translumenal endoscopic surgery
Transvaginal translumenal endoscopic surgery
Lead sponsor: Hospital Son Llatzer
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Parietal complications after surgery (infection and hernia)
timeFrame: One year
Secondary outcomes:
measure: Surgical pain. General complications. Patient's preferences.
timeFrame: One year
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer
state: Illes Balears.
Study officials:
affiliation: Hospital Son Llàtzer
name: Angel Cuadrado, MD PhD
role: STUDY_CHAIR
References:
citation: Dolz C, Noguera JF, Martin A, Vilella A, Cuadrado A. [Transvaginal cholecystectomy (NOTES) combined with minilaparoscopy]. Rev Esp Enferm Dig. 2007 Dec;99(12):698-702. doi: 10.4321/s1130-01082007001200004. Spanish.
citation: Noguera JF, Cuadrado A, Dolz C, Olea JM, Garcia JC. Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250). Surg Endosc. 2012 Dec;26(12):3435-41. doi: 10.1007/s00464-012-2359-4. Epub 2012 May 31.