Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cholelithiasis

Intervention / Treatment
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* Procedure: Transvaginal hybrid NOTES cholecystectomy
* Procedure: Cholecystectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopy<br>Laparoscopic cholecystectomy | Procedure: Cholecystectomy<br>* Extirpation of the gallbladder by a surgical procedure<br>|
| Experimental: Transumbilical<br>Transumbilical endoscopic cholecystectomy | Procedure: Cholecystectomy<br>* Extirpation of the gallbladder by a surgical procedure<br>|
| Experimental: Transvaginal<br>Transvaginal endoscopic cholecystectomy | Procedure: Transvaginal hybrid NOTES cholecystectomy<br>* 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.<br>* Other names: Transvaginal cholecystectomy;Procedure: Cholecystectomy<br>* Extirpation of the gallbladder by a surgical procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parietal complications after surgery (infection and hernia) |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical pain. General complications. Patient's preferences. |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transvaginal cholecystectomy, NOTES, Minilaparoscopy, Endoscopic surgery, Cholecystectomy, Surgical translumenal endoscopic surgery, Transvaginal translumenal endoscopic surgery