Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy (NATCH)

October 12, 2013 updated by: Dirk R. Bulian, University of Witten/Herdecke

Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy: a Randomized Clinical Trial

Laparoscopic surgery has become the golden standard for the removal of the gallbladder. Recently, developments have been made so that operations can be performed through a natural orifice instead of the abdominal wall, thus minimizing the trauma of a procedure. This study compares the transvaginal/transumbilical cholecystectomy with the laparoscopic operation using 2-3mm instruments in female patients. It also examines the benefits and disadvantages related to postoperative pain, cosmetic aspects, and potential physiological alterations to the transvaginal approach that affect sexual intercourse.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The amount of trauma inflicted, especially in abdominal operations, depends largely on target organ access. Great efforts have been made to minimize access trauma. The further development of laparoscopy led to the miniaturization of surgical instruments and otherwise the use of natural orifices, like the stomach, rectum or vagina. The cholecystectomy is currently performed needlescopicly with 2-3 mm trocars and in transumbilically assisted transvaginal technique. The aim of this randomized study is to compare these two techniques in female patients that are in need of an elective cholecystectomy. The patients will be randomized on a 1:1 ratio into two treatment groups. In the needlescopic group the investigators will use two 2-3 mm working trocars and one 10 mm optic trocar, also to extract the gallbladder. In the transvaginal/transumbilical group the investigators will perform the Zornig technique using a 5 mm trocar in the umbilicus and a 10 mm trocar together with a 5 mm seizing forceps through the posterior vaginal vault. The primary endpoint of this trial is to measure the intensity of pain in motion measured from the day of the operation until postoperative day 2. Four different measurements of pain will be used. Furthermore the investigators examine perioperative complications as security parameters. The trial is supported in part by the German Ministry of Research and Education (CHIR-Net grant, BMBF No. 01-GH-0605).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Germany
      • Cologne, Germany, 51109
        • Department of Abdominal, Vascular and Transplant Surgery; Cologne-Merheim Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gender: Female
  • Minimum Age: 18 Years
  • Maximum Age: 80 Years
  • indication for elective cholecystectomy on account of symptomatic cholecystolithiasis
  • age >=18 years and <=80 years
  • legal competence

Exclusion Criteria:

  • Acute cholecystitis or locally complicated disease (gallbladder empyema, choledocholithiasis, pancreatitis, etc.)
  • liver cirrhosis (Child Pugh A, B, C)
  • severe comorbidity, class IV or V as defined by the American Society for Anesthesiologists (ASA)
  • intact hymen
  • acute vaginal infection
  • lacking visibility of the uterine orifice
  • endometriosis
  • malignoma
  • obesity with a Body Mass Index (BMI) > 40 kg/m2
  • chronic abuse of analgesics or alcohol
  • neuromuscular disease that could interfere treatment or measures of pain
  • history of major abdominal surgery with a high risk of intraperitoneal adhesions (minor operations such as an appendectomy, inguinal hernia repair, minor gynaecological surgery, etc. will not be considered exclusion criteria)
  • gravidity or breastfeeding
  • allergy against analgesics
  • patients who are dependent on or employed by the trial sponsor or physicians
  • institutionalisation for legal reasons
  • participation in other clinical studies that could interfere with the present trial
  • no written informed consent signed

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transvaginal/transumbilical cholecystectomy
Transvaginal/transumbilical group: we will use a 5 mm trocar in the umbilicus and a 10 mm trocar together with a 5 mm seizing forceps through the posterior vaginal vault to perform the cholecystectomy in the Zornig style
Procedure: Transvaginal/transumbilical
Active Comparator: Needlescopic cholecystectomy
Needlescopic cholecystectomy with 3 trocars: we will use two 2-3 mm working trocars and one 10 mm optic trocar, its access is also used for extraction of the gallbladder
Procedure: Needlescopic with 3 trocars

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intensity of pain in motion
Time Frame: at the operation day
Pain Scores on the Visual Analog Scale (0-10)
at the operation day
Intensity of pain in motion
Time Frame: at postoperative day 1
2 measures (in the morning and in the evening) Pain Scores on the Visual Analog Scale (0-10)
at postoperative day 1
Intensity of pain in motion
Time Frame: at postoperative day 2
Pain Scores on the Visual Analog Scale (0-10)
at postoperative day 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cosmetic aspects and overall satisfaction with the results of the surgery
Time Frame: 10 days after operation
1 (complete satisfaction) to 5 (complete dissatisfaction) scale from patient's and surgeon's point of view
10 days after operation
Intraoperative complications
Time Frame: evaluated at the operation day
e.g. bleeding, organ-injury, especially bile-duct-injury
evaluated at the operation day
Duration of the operation
Time Frame: at the operation day
(in minutes)
at the operation day
Surgical handling for the first and second surgeon
Time Frame: evaluated at the operation day
on a 1 to 5 scale
evaluated at the operation day
Intensity of pain in motion
Time Frame: at postoperative day 2
in the evening pain Scores on the Visual Analog Scale (0-10)
at postoperative day 2
Cumulative use of analgesics
Time Frame: 10 days after the surgery
quantity, dose and class of the used drugs
10 days after the surgery
Return to everyday, work related and free time activities
Time Frame: 3 months after operation
duration of limitations.
3 months after operation
Quality of life
Time Frame: on postoperative day 10
measured with the Gastrointestinal Quality of Life Index (GIQLI) from Eypasch et al.
on postoperative day 10
Postoperative restrictions of sexual function
Time Frame: 3 months after surgery
with questions 14-19 of the "female sexual function index" (FSFI-D)
3 months after surgery
Morphological consequences of transvaginal access
Time Frame: at the day before the operation, and again 10 to 14 days and 6 months after their surgery
all patients from the transvaginal/transumbilical group will be examined by a gynaecologist
at the day before the operation, and again 10 to 14 days and 6 months after their surgery
Cosmetic aspects and overall satisfaction with the results of the surgery
Time Frame: 3 months after operation
1 (complete satisfaction) to 5 (complete dissatisfaction) scale from patient's and surgeon's point of view
3 months after operation
Cosmetic aspects and overall satisfaction with the results of the surgery
Time Frame: 6 months after operation
1 (complete satisfaction) to 5 (complete dissatisfaction) scale; from patient's and surgeon's point of view
6 months after operation
Conversionrate
Time Frame: at the operation day
Conversion from transvaginal to classical laparoscopic or open technique and from needlescopic to open technique
at the operation day
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: at 6 month
including frequency of reoperation
at 6 month
Intensity of pain in motion
Time Frame: at postoperative day 3
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
at postoperative day 3
Intensity of pain in motion
Time Frame: at postoperative day 4
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
at postoperative day 4
Intensity of pain in motion
Time Frame: at postoperative day 5
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
at postoperative day 5
Intensity of pain in motion
Time Frame: at postoperative day 6
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
at postoperative day 6
Intensity of pain in motion
Time Frame: at postoperative day 7
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
at postoperative day 7
Intensity of pain in motion
Time Frame: at postoperative day 8
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
at postoperative day 8
Intensity of pain in motion
Time Frame: at postoperative day 9
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
at postoperative day 9
Intensity of pain in motion
Time Frame: at postoperative day 10
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
at postoperative day 10

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Witten/Herdecke

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dirk R. Bulian, Witten/Herdecke University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U1111-1114-7386
  • DRKS00000341 (Registry Identifier: DRKS-ID)

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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