Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery

March 11, 2013 updated by: Jose F. Noguera, Hospital Son Llatzer

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Illes Balears.
      • Palma de Mallorca, Illes Balears., Spain, 07140
        • Hospital Son Llatzer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Laparoscopy
Laparoscopic cholecystectomy
Procedure: Cholecystectomy
Extirpation of the gallbladder by a surgical procedure
EXPERIMENTAL: Transumbilical
Transumbilical endoscopic cholecystectomy
Procedure: Cholecystectomy
Extirpation of the gallbladder by a surgical procedure
EXPERIMENTAL: Transvaginal
Transvaginal endoscopic cholecystectomy
Procedure: Cholecystectomy
Extirpation of the gallbladder by a surgical procedure
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.
Other Names:
  • NOTES cholecystectomy
  • Transvaginal cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Parietal complications after surgery (infection and hernia)
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Surgical pain. General complications. Patient's preferences.
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Son Llatzer

Investigators

  • Study Chair: Angel Cuadrado, MD PhD, Hospital Son Llatzer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

February 2, 2009

First Submitted That Met QC Criteria

February 2, 2009

First Posted (ESTIMATE)

February 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 12, 2013

Last Update Submitted That Met QC Criteria

March 11, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LLATZERNOTES-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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